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Disclaimer:

The Saudi Guidelines on the Prevention and Management of Obesity


developed by the Obesity Control Program is not meant to replace
clinical judgments of physicians but are only tools to help the
practicing doctors to manage obese patients. Although a lot of effort
was exerted to ensure the accurate names and doses of medications,
the authors encourage the readers to refer to the medications’
information for further clarification.
i

CONTENTS:
ABBREVIATIONS iii
FORWARD BY THE DIRECTOR GENERAL iv
WORD FROM SAUDI ARABIAN SOCIETY OF METABOLIC AND BARIATRIC SURGERY v
ACKNOWLEDGEMENT vi
INTRODUCTION 1
Magnitude of the problem in the Kingdom of Saudi Arabia (KSA) 1
GUIDELINES DEVELOPMENT PROCESS 2
Scope of guidelines 2
Aim of the guidelines 2
Clinical question to be answered 2
Development process 3
Implementation strategies 4
Update of the guidelines 4
HOW TO USE THE GUIDELINES 5
PRIMARY PREVENTION OF OBESITY IN CHILDREN, ADOLESCENTS AND ADULTS 6
Guidelines for Healthy Eating 7

Guidelines for Physical Activity 9


Children 9
Adults 9
WEIGHT MANAGEMENT IN CHILDREN 10
Clinical and laboratory assessment of overweight and obesity in children 12
Devise goals 12
Management of obesity in children and adolescents 12
Referral of children and adolescents to secondary or tertiary care 14
Plan for regular monitoring of weight management in children and adolescents 14
ii

WEIGHT MANAGEMENT IN ADULTS 15


Clinical and laboratory assessment of overweight and obesity 17
Assess for readiness to change lifestyle behaviors’ 22
Management of obesity 25
Devise goals 25

Psychological/behavioral interventions 27
Long-term weight management 28
Referral for specialist support 28
PHARMACOLOGICAL TREATMENT 29
BARIATRIC SURGERY 35
ANNEX 1: KEY TO EVIDENCE STATEMENTS AND GRADES OF RECOMMENDATIONS 43
ANNEX 2: MEMBERS OF ADOPTION GROUP OF FIRST DRAFT OF THE GUIDELINES 47
ANNEX 3: OBESITY CONTROL PROGRAM SCIENTIFIC COMMITTEE 48
ANNEX 4: GUIDELINES PREPARATION COMMITTEE 49
ANNEX 5: CHARTS FOR BMI TO AGE PERCENTILES AMONG CHILDREN 50
iii

ABBREVIATIONS:
ASBP American Society of Bariatric Physicians
ACEI Angiotensin-converting-enzyme inhibitor
ARB Angiotensin receptor blockers
BMI Body mass index
CVD Cardio-vascular disease
CCB Calcium-channel blocker
GAG Guidelines Adoption Group
HDL High- density lipoprotein
ICSI Institute for Clinical Systems Improvement
Kcal Kilo-calorie
Kg Kilo-gram
KSA Kingdom of Saudi Arabia
LDL Low-density lipoprotein
NICE National Institute for health and Care Excellence (UK)
NCD Non-Communicable Disease
NHMRC National Health and Medical Research Council (Australia)
SAGES Society of American Gastrointestinal and Endoscopic Surgeons
SASMBS Saudi Arabian Society of Metabolic and Bariatric Surgery
SIGN Scottish Intercollegiate Guidelines Network
SHIS Saudi Health Information Survey
TSH Thyroid-stimulating hormone
WC Waist circumference
iv

FORWARD :
The health system in KSA has witnessed enormous development and reforms during the last few decades; however, it
continues to face many emerging challenges. The country is already experiencing the demographic and epidemiologic
transitions, whereby the health scene is dominated by non-communicable diseases (NCDs).

In the Kingdom of Saudi Arabia, obesity and overweight has become one of the most common public health problems
affecting people of both sexes and all age groups. The prevalence is on the rise, which requires prompt actions and
efforts from health and related stakeholders.

We are putting forward these evidence based guidelines for obesity to health care workers in the Kingdom of Saudi
Arabia. The guidelines have been adapted by national experts who are also users of clinical guidelines in their own
practices. They are intended to provide health care professionals with the tools to effectively prevent and manage
overweight and obesity.

We are very grateful to H.E. the Minister of Health for his constant support and advice to the General Directorate for
Control of Genetic and Chronic Diseases to combat NCDs and its risk factors in the country.

Looking forward to see tangible results of this effort in combating obesity in the country.

Dr. Mohammad Y. Saeedi, General Director


General Directorate for Control of Genetic & Chronic Diseases
Ministry of Health, Riyadh,
Kingdom of Saudi Arabia
v

WORD FROM SAUDI ARABIAN SOCIETY OF METABOLIC AND BARIATRIC


SURGERY:
Saudi Arabian Society of Metabolic and Bariatric Surgery is one of the growing societies that were established in 2010
under the umbrella of the Saudi Commission for Health Specialties. One of the aims of the society includes publishing
and disseminating clinical guidelines on prevention and treatment of obesity in Saudi Arabia.

Overweight and obesity affect more than 60% of the total population in Saudi Arabia. Almost all age groups are affected
in general and adults in particularly. In order to introduce high quality health-care for these individual, it is mandatory
to establish clinical guidelines that will help health-care providers to manage this common problems at all levels. These
guidelines are adapted from Scottish Intercollegiate Guidelines Network (SIGN) for management of obesity after taking
permission in this regard. The guidelines will cover preventive and curative aspects of overweight and obesity and could
be implemented at primary, secondary, and tertiary care levels in Saudi Arabia.

Finally we thank the Scientific Committee of Saudi Arabian Society of Metabolic and Bariatric Surgery for adapting these
guidelines and acknowledge the untiring efforts of our partner; the General Directorate for Control of Genetic and
Chronic Diseases, Ministry of Health, Kingdom of Saudi Arabia, for their major contribution in issuing the guidelines. We
hope that all health care providers will implement it in order to introduce the best quality health care for our community.

Dr. Waleed S Abu-Melha, President,


MBBS/CABFM/Fellowship Obesity,
Department of Preventive Medicine, Military Hospital, Khamis Mushyait, KSA
vi

ACKNOWLEDGEMENT:
First and foremost I offer my sincerest gratitude to the Director General of the General Directorate for Control of Genetic
and Chronic Diseases, who has supported us throughout preparation process in developing these guidelines. His
guidance, enthusiastic encouragement and useful critiques were valuable.

I would also like to thank the Saudi Arabian Society of Metabolic and Bariatric Surgery (SASMBS) where these Guidelines
are based on their work which was published in the Saudi Journal of Obesity.

Special thanks are extended to the members of adoption group of first draft of the guidelines of obesity for their unlimited
help.

I would like to express my appreciation to obesity control program scientific committee and guidelines preparation
committee for their valuable and constructive suggestions during planning and development of this work. Their
willingness to give their time so generously has been very much appreciated.

Finally, I would also like to extend my thanks to the obesity program coordinators, doctors and nurses from all the regions
of the Kingdom for their dedicated work.

Dr. Shaker Abdulaziz Alomary


Director of Obesity Control Program
Ministry of Health, Kingdom of Saudi Arabia
1

INTRODUCTION:
Obesity results from accumulation of body fats overtime. It occurs when the energy intake exceeds energy requirements.
This could occur as a result of many factors including increased food intake, physical inactivity, and genetic factors1,2.

Obesity is a key risk factor for many non-communicable diseases (NCDs), including type 2 diabetes, hypertension, heart
disease and some cancers. The risk increases with increase in the level of obesity. Obesity and overweight are also strongly
associated with mental health and eating disorders2, 3, 4.

Obesity and overweight have become the most prevalent nutritional problems in the world putting an increased burden
on the health care system. They affect almost one third (2.1 billion people) of the global population and result in five
percent of all deaths worldwide3,4,5. The magnitude of the problem may reach almost half of the world’s adult population
by 2030 if the current trend persists6.

A comprehensive, systemic multi-sectoral program comprising of multiple interventions involves and includes broad
behavioral change component is required to produce positive impact in managing obesity among the population. Physical
activity and nutritional behavior are a vital part of any obesity control program. This necessitates the development of
multi-setting programs (e.g. schools and work-places). Prevention efforts should also invest in, and target all age groups
and individuals with parental and/or family involvement3,5.

Magnitude of the problem in the Kingdom of Saudi Arabia (KSA)


In Saudi Arabia, obesity has become one of the most common public health problems affecting people of both sexes
and all age groups. According to Saudi Health Interview Survey (SHIS) conducted in 2013, obesity and overweight affect
28.7% and 30.7% of individuals 15 years and older respectively (collectively overweight and obesity affect 59.4% of the
total population). The prevalence of obesity among adult males and females was 24.1% and 33.5% respectively, while
33.4% adult males and 28.0% females were overweight 7.
2

GUIDELINES DEVELOPMENT PROCESS:

Scope of guidelines:

These guidelines address the following areas:


• Prevention of overweight and obesity in children and adults through education and counseling.
• Prevention of overweight and obesity through screening high-risk individuals.
• Management of overweight and obesity through life-style changes, drugs and surgical interventions.

Aim of the guidelines:

The guidelines aim to provide recommendations for the prevention and management of overweight/obesity in children
and adults based on current evidence for best practices that is suitable for our target population, culture, health-care
system, and resources.

Clinical question to be answered:

The following five items (PIPOH) were used to define the health question and cover different aspects 8:
(P) The Population concerned and characteristic of disease condition:
- The target population includes all sex and age groups.
(I) The Interventions of interest:
- Screening the population for overweight and obesity.
- Psychological, dietary and physical exercise interventions.
- Referral to secondary and tertiary care for further assessment and management.
(P) The Professionals to whom the guidelines will be targeted:
- These guidelines are intended for the use of healthcare professionals at all levels, including physicians, nurses,
dietitians, psychologists and physiotherapists.
3

(O) The expected Outcome including patients, public and system outcome:
- To reduce the prevalence of overweight and obesity and their co-morbidities.
- To reduce the expenditure on the health system.
- To decrease clinical practice variation.
(H) The Health care setting and context in which the guidelines are to be implemented:
- PHC centers and Hospitals.

Development process:

The General Directorate for Control of Genetic and Chronic diseases (NCDs) constituted a team to develop
“Saudi Guidelines for the Prevention and Management of Obesity”. The team operated under supervision of the
Director General of NCDs and headed by the Director of Obesity control Program (members of the team are listed at
annex 3). The assistance of the Obesity Control Programhs Scientific Committee was available for guidance during
the process.
The team reviewed the Clinical Practice Guidelines for the Prevention and Management of Obesity in Saudi Arabia
developed by the Saudi Arabian Society of Metabolic and Bariatric Surgery (SASMBS); and also conducted a rigorous
review of relevant evidenced based scientific literature. After a thorough assessment, a consensus was reached to use
the SIGN guideline as the main guideline based on the work of SASMBS and to fill the gap from the following guidelines9:
• Clinical Practice Guidelines for the Management of overweight and obesity in adults, adolescents and children in
Australia.
• 2006 Canadian clinical practice guidelines on the management and prevention of obesity in adults and children.
• NICE (National Institute for health and Care Excellence) guidelines - Obesity: identification, assessment and
management of overweight and obesity in children, young people and adults (November 2014).
• Institute for Clinical Systems Improvement (ICSI) guideline for Prevention and Management of Obesity for Children
and Adolescents.
4

To avoid duplication of efforts, the team adopted the grading of evidence used by different guidelines used in this
document (annex1).

The updated version was presented in a workshop, involving the Obesity Control Program Scientific Committee, in
addition to other relevant stakeholders and the recommendation of the participants were included.

The final draft was distributed for review by Obesity Control Program Scientific Committee and their comments were
included (annex 3 lists the membership of the Committee).

Implementation strategies:

Obesity Control Program will be responsible for implementation of the guidelines with the support of regional
directorates. The printed document will be distributed to all targeted health professionals. Training of Trainers (TOT)
will be organized at national level to train regional level trainers.

Wide scale training workshops will be conducted at regional level to train health professionals from primary and
secondary level health facilities.

Feedback will be obtained from health professionals trained on the guidelines, and their recommendations will be
considered in updating the future edition.

Update of the guidelines:

Updating the guidelines will be considered every 5 years.


5

HOW TO USE THE GUIDELINES:


The goal of these Guidelines is to provide health care professionals with the tools to effectively prevent and manage
overweight and obesity among children and adults. The guidelines are structured as follows:

Chapter (1) is on primary prevention of obesity among children, young people and adults; the guidelines provide information
on preventing overweight and obesity through lifestyle modification program, focusing on recommendations for healthy
diet, physical activity and periodic medical examination.

Chapters (2&3) are about weight management in children and adults; where the guidelines introduce two algorithms to be
followed for assessment and management of obesity and overweight. The assessment is based on Body Mass Index (BMI) for
age percentiles for children and BMI and Waist Circumference (WC) for adult, in addition to a set of laboratory investigation
to assess for underlying causes, risk factors and co-morbidities.

Chapter (4) explains pharmacological management of obesity; it briefly presents a list of medications used for pharmacological
treatment. It provides brief description of each medication including mechanism of action, indications, contraindications,
maintenance dosage and mode of administration.

Chapter (5) on surgical management of obesity (bariatric surgery); it describes briefly the indications for considering bariatric
surgery as part of obesity management pass-way. It describes briefly the common types of bariatric surgery highlighting its
potential short term and long term complications.

Different grades are used in the document based on the source of evidence. In order to effectively use the document
the reader should refer to annex 1, which summarizes the grade of evidences used by different sources quoted in this
document.
6

Chapter 1

PRIMARY PREVENTION OF OBESITY IN CHILDREN,


ADOLESCENTS AND ADULTS
7

PRIMARY PREVENTION OF OBESITY IN CHILDREN, ADOLESCENTS AND


ADULTS:
• For all age groups, assess diet, physical activity and sedentary behaviors annually (ICSI, strong recommendation, high
quality evidence)10.

Guidelines for Healthy Eating:

Birth to five years:


• Recommend exclusive breastfeeding from birth up to the age of six months (ICSI, High Quality Evidence)11,10.
• Gradually introduce solid food starting at the age of six months11.
• Carefully introduce – one at a time- foods which may cause allergies such as milk, eggs, wheat, seeds, nuts, fish and
shellfish11.
• Provide three meals and two between-meal snacks for children one year old11.
• Avoid high fiber foods and large volume of full fat dairy products in below two years children11.
• Introduce gradually, low fat dairy products, for normally growing above two years old children11.
• Adjust salt intake to the age of the child; (less than 1 g/day up to age 12 months; from 1-3 years no more than 2 g/day
and a maximum of 3 g/day for 4-6 year olds) 11.

Children above five years and adults


• Recommend food in accordance with healthy eating guidelines from the age of five years onwards unless there is
specific clinical dietary requirement (see table 1). Adjust portion sizes to age, gender, weight and activity level10,11 :
- Encourage the child to eat to appetite.
- Encourage children to eat regular meals including breakfast (ICSI, strong recommendation, high quality evidence)10
- Discourage availing easy access to foods not recommended for the child11.
- Encourage intake of low salt foods and limit the intake of energy-dense foods and fast foods (SIGN, Evidence
grade B) 11.
- Follow the 5-2-1-0 message every day:
8

* 5= Encourage intake of daily 5 portions of fruits and vegetables (ICSI, strong recommendation, high
quality evidence).
* 2= Encourage eating with the child in a sociable atmosphere without distractions, separate eating from other
activities and keep recreational screen time to less than 2 hours, (ICSI, strong recommendation, high quality
evidence)10.
* 1= Include at least 1 hour or more of active play every day (see physical activity section below).
* 0= Skip sugar sweetened beverages, drink more water every day.
• Advise patients using medications associated with weight gain on weight management, as shown in table 3 (SIGN,
evidence grade B)11.

Table 1: The eat-well plate guidelines (8)

Food group Recommendation


Bread, rice, potatoes, pasta, and other starchy foods Eat plenty, choose whole-grain varieties when you can
Fruits and vegetables Eat plenty, at least 5 portions of a variety of fruit and vegetables a day
Milk and dairy foods Eat some, choose lower fat alternatives whenever possible or eat higher fat versions
infrequently or in smaller amounts
Meat, fish, eggs, beans, and other non-dairy sources of Eat some, choose lower fat alternatives whenever possible or eat higher fat versions
protein infrequently or in smaller amounts. Aim for at least two portions of fish a week,
including a portion of oily fish
Foods and drinks high in fat and/or sugar Consume just a small amount

Source: SIGN Guidelines


9

Guidelines for Physical Activity:

Children:
• Encourage children gradually to perform at least 60 minutes of moderate to vigorous exercise daily – continuous or
accumulated in short bouts (ICSI, Moderate Recommendation, High Quality Evidence)10,11.
• Encourage children to lead active daily life such as walking, cycling, skipping and using the stairs and support them to
practice regular physical activity appropriate to their age and ability such as football and swimming11.
• Discourage sedentary behavior of more than two hours for children particularly of screen time, like watching TV,
computer use and playing video games (ICSI, strong recommendation, high quality evidence)10,11.
• Encourage family approach to physical exercise (e.g. walking and cycling to school and shops, going to the park or for
swimming) 11.

Adults:
• Provide physical activity advice appropriate to specific individual situation. The focus should be on activities that can
fit easily into their everyday lives and are tailored to their individual preferences and circumstances. Attention should
be given to pregnant women, those at risk of post-natal weight retention, women reaching the age of menopause, or
while quitting smoking11.
• Inform the individuals about the benefits of physical activity on reducing the risk of Cardiovascular Disease (CVD) and
type 2 diabetes, even without evident weight reduction11.
• Encourage adults to do at least 30 minutes of moderate-intensity physical activity on 5 or more days a week. This
should be built up over time; start by walking 10 minutes a day on a few days during the first couple of weeks then
add more time and days gradually11.
10

Chapter 2

WEIGHT MANAGEMENT IN CHILDREN


11

Algorithm for Managing Overweight and Obesity in Children


Measure BMI (age and sex-specific percentile) Assess for co-morbidities and underlying causes
If BMI for age percentile (>85th - <95th centile - Assess eating, physical activity, emotional/ psychological issues and use of medications
(overweight) - Conduct clinical and laboratory investigations if indicated
If BMI for age percentile > 95th centile (obese) - Assess the readiness for behaviors change and barriers to weight loss

YES NO
PATIENT
Determine Goals WILLING TO
- Pre-pubertal: Weight maintenance rather than weight loss.. Offer lifestyle advice
- Post-pubertal: weight loss rather than weight maintenance CHANGE

Lifestyle modification program Repeat previous option

Progress towards achieving goals NO RE EVALUATE

YES Refer to specialist services for


Weight maintenance and prevention of weight gain:
- Nutritional therapy • Disordered eating, poor body image, depression and anxiety
- Physical activity • Management of co-morbidities such as sleep apnea,
- Cognitive-behavior therapy orthopedic problems, risk factors for cardiovascular disease or
type 2 diabetes and psychological distress.
• An underlying medical or endocrine cause is suspected
• Concerns about height and development
• Pharmacologic or bariatric surgery

Adapted from 2006 Canadian clinical practice guidelines & SIGN Guidelines
12

WEIGHT MANAGEMENT IN CHILDREN


Clinical and laboratory assessment of overweight and obesity in children:

• Use the Saudi sex-specific BMI for age percentile chart for assessing overweight and obesity in infants and children
0-19 years of age (there are two sets of gender specific charts, Birth to 36 months and 2 to 19 years (see annex 5)).
The Growth Chart for Saudi Children and adolescents categorizes overweight as between the 85th and 95th
percentile and obesity as above the 95th percentile12,13,14 .
• Inquire about the presence of parental obesity, type 2 diabetes and CVD which are a strong predictor of a child’s
weight and co-morbidities (ICSI, Strong Recommendation, High Quality Evidence)4,10.
• Assess child developmental history, physical and mental health and assess for current health problems, co-
morbidities (e.g. raised blood pressure, joint pain, gastrointestinal symptoms, insulin resistance, intertrigo, dental
health) and risks for future disease (ICSI, Strong Recommendation, High Quality Evidence) 4,10.

Devise goals:

• In children and pre-pubertal adolescents the goal should be weight maintenance rather than weight loss.
Maintaining weight during growth will result in a declining BMI and will prevent potential adverse effects (NHMRC,
evidence grade D)4,5.
• In post-pubertal adolescents the goal is weight loss rather than weight maintenance4,5.

Management of obesity in children and adolescents:

• Recommend early start of weight management in children and adolescents with the objectives of preventing
adulthood overweight or obesity, reducing risk of co-morbidities and enhancing healthy life style behaviors 4.
• Target weight management of the child or adolescent through family approach – addressing healthy lifestyle
behavior of the whole family (ICSI, Strong Recommendation, High Quality Evidence and NHMRC, evidence grade PP4.
• Recommend frequent contacts with health professionals for children and adolescents (NHMRC, evidence grade B)4.
• Consider child preference, ability and strength when choosing lifestyle activities. It is recommend that the activities
13

should be fun, recreational and tailored to the relative strengths of child and family (Canadian, evidence grade A,
level 2)3.
• Lifestyle interventions should focus on changing the health behaviors, consume healthy diet, and perform physical
activity 4,10 :
- Advise the reduction of screen time to less than 2 hours per day (ICSI, Strong Recommendation, High Quality
Evidence).
- Encourage daily 60 minutes of moderate and vigorous exercise, e.g. household tasks, walking to school, sports
clubs, swimming pool, walking tracks. etc (ICSI, Strong Recommendation, moderate Quality Evidence).
- Encourage children to have regular meals in a sociable atmosphere (ICSI, Strong Recommendation, High Quality
Evidence).
- Encourage children to eat a nutrient-dense breakfast daily (ICSI, High Quality Evidence).
- Discourage eating energy-dense food, like fast food (ICSI, High Quality Evidence).
- Encourage children to eat to appetite (ICSI, Moderate Quality Evidence).
- Advice on availing healthy food choices.
- Encourage drinking water instead of sugary drinks and energy drinks (ICSI, Strong Recommendation, High Quality
Evidence).
- Advice on separating eating from other activities, e.g. watching TV (ICSI, Moderate Quality Evidence).
• Weight management of obese child should include a family based behavior change components targeting lifestyle
change of the whole family (SIGN, evidence grade B)11.
• Sustained behavioral changes are essential to achieve weight maintenance and/or weight loss in children (SIGN,
evidence grade D)11.
14

Referral of children and adolescents to secondary or tertiary care:

• Specialist services may be required for the following (NHMRC, evidence grade D) 4:
- Disordered eating,
- Poor body image,
- Depression and anxiety,
- Presence of co-morbidities (e.g. sleep apnea, orthopedic problems, risk factors for cardiovascular disease or type
2 diabetes and psychological distress),
- Suspected underlying medical or endocrine cause, and
- Concerns about height and development.
• Referral for pharmacologic or bariatric surgery may be considered in post-pubertal adolescents, with severe obesity
(a BMI > 40 kg/m2 or > 35 kg/m2 with obesity-related complications), who failed to respond to lifestyle interventions
(NHMRC, evidence grade D)4.

Plan for regular monitoring of weight management in children and adolescents:

• Follow-up the cases regularly every 3 months (NHMRC, evidence grade PP)4.
15

Chapter 3

WEIGHT MANAGEMENT IN ADULTS


16

Adapted from 2006 Canadian clinical practice guidelines & SIGN Guideline
17

WEIGHT MANAGEMENT IN ADULTS

Clinical and laboratory assessment of overweight and obesity:

• Obtain a thorough history and a general physical examination to assess obesity, overweight and obesity related risks
and to exclude secondary causes of obesity (Canadian, evidence grade A, level 3)3,4. See tables 2 to 9 for details.
• Measure body mass index (BMI) (weight in kilograms divided by height in meters squared) to assess overweight or
obesity in adults - (Canadian, evidence grade A, level 3)3,4. Table 2 provides the reference for different BMI categories.
• Measure the waist circumference (WC) in addition to BMI to assess for abdominal fat and risk of obesity-related co-
morbidities particularly cardiovascular disease and diabetes (Canadian, evidence grade A, level 3)3. Males with WC ≥
102 cm and females with WC ≥88 cm are at high-risk of the above mentioned complications, see Table 3 11.
• Request/ Conduct laboratory tests when appropriate to assess for co-morbidities. Recommended tests include:
- Fasting plasma glucose level, lipid profile, including total cholesterol, triglycerides, low-density lipoprotein
cholesterol (LDL), high-density lipoprotein (HDL) and ratio of total cholesterol to HDL (Canadian, evidence grade A,
level 3)3.
- Liver enzyme tests, urinalysis and sleep studies (Canadian, evidence grade B, level 3)3.
• Refer for professional assessment as appropriate for eating disorders, depression and psychiatric disorders
(Canadian, evidence grade B, level 3)3.
18

Table 2: Classification of Obesity 2 Table 3: Measuring Waist Circumference 4


BMI Class • Use a measuring tape that is checked monthly for stretching (replace if
<18.5 Underweight stretched).
18.5-24.9 Normal • Ask the person to remove heavy outer garments, loosen any belt and empty
25-29.9 Overweight pockets.
30-34.9 Obesity class I (mild) • Ask the person to stand with their feet fairly close together (about 12–15 cm)
35-39.9 Obesity class II (moderate) with their weight equally distributed and to breathe normally.
≥40 Obesity class III (morbid obesity) • Holding the measuring tape firmly, wrap it horizontally at a level midway
between the lower rib margin and iliac crest (approximately in line with the
umbilicus). The tape should be loose enough to allow the measure to place one
finger between the tape and the person’s body.
• Record the measurement taken on an exhalation

Table4: Risk factors of obesity 15


Evidence has shown that individuals with following conditions are at high-risk of becoming overweight or obese.
• After smoking cessation.
• On certain medications (see table 5)
• Polycystic ovarian syndrome
• Hypothyroidism and pseudo-hypoparathyroidism
• Hypogonadism
• Cushing syndrome
• Hypothalamic Obesity
• Genetic Syndromes (e.g. Prader-Willi syndrome, Alstrom syndrome, Bardet-Biedl syndrome, Cohen syndrome, Borjeson-Forssman-Lehmann
syndrome, Frohlich syndrome)
• Growth hormone deficiency
• Eating disorders (especially binge-eating disorder, bulimia nervosa, and night eating disorder)
• Dyslipidemia.
• Family history of obesity.
• Pregnancy, post-natal weight retention, and at the menopause
19

Table 5: Medications that interfere with weight loss or induce weight gain15
Medication Class Alternatives
Antipsychotics/ Mood Stabilizers Ziprasidone, Aripiprazole
• Phenothiazines
• Atypical antipsychotics: Clozapine, olanzapine, risperidone, quetiapine
• Lithium
Antidepressants: Nefazodone, Bupropion, Venlafaxine
• Sedating tricyclics: Amitriptyline > imipramine
• Monoamine oxidase inhibitors (non-selective): Isocarboxazid, Phenelzine, tranylcypromine
• Selective serotonin reuptake inhibitors: Paroxetine > citalopram, fluvoxamine, sertraline
• Mirtazapine
Antiepileptics: Lamotrigine, Topiramate
• Gabapentin, Valproate, Carbamazepine, Pregabalin
Antiepileptics/antipsychotics used in bipolar disorder Lamotrigine, Topiramate, Ziprasidone
• Valproate, Carbamzepine, Clozapine, Olanzapine, Risperidone
• Hormonal contraceptives Barrier methods
• Corticosteroids NSAIDs
Progestational steroids: Weight loss Aromatase Inhibitors
• Megestrol acetate
Antidiabetic agents: Metformin, Acarbose
• Insulin
• Sulfonylureas
• Thiazolidinediones
Antihypertensives: ACEI, ARB, Diuretics, CCB
• Beta and alpha1- adrenergic blocking agents
Antihistamines: Diphenhydramine, Decongestants, inhaler
• Cyproheptadine
20

Table 6: Co-morbidities and consequences of obesity15


Cardiovascular Respiratory
• Hypertension • Dyspnea
• Heart failure • Obstructive sleep apnea
• Coronary artery diseases • Hyperventilation syndrome
• Varicose veins • Pick wickian syndrome
• Pulmonary embolism • Asthma
Endocrine Gastrointestinal
• Metabolic syndrome • Gastro-esophageal reflux diseases,
• Diabetes type 2 • Fatty liver disease
• Dyslipidemia • Cholelithiasis,
• Polycystic ovarian syndrome • Hernias
• Reduced fertility and menstrual disorders • Pancreatitis
• Pregnancy complications
Genitourinary Surgical
• Urinary stress incontinence • Increased surgical risk
• Obesity related glomerulopathy • Increased post-operative complications
Neurologic Musculoskeletal
• Stroke • Osteoarthritis (knee and hip)
• Idiopathic intracranial hypertension • Immobility,
• Meralgia parasthetica • Low back pain
• Dementia • Hyperuricemia and gout
Psychological Cutaneous
• Depression/ low self-esteem • Stretch marks
• Body image disturbances • Status pigmentation of legs
• Social stigmatization • Lymph edema
Neoplasms • Cellulitis
• Breast cancer • Intertrigo and carbuncles
• Uterine cancer • Acanthosis nigricans
• Colonic cancer • Skin tags
21

Table 7: Diagnostic Evaluation of Obese Patient15:


All obese\ patients • BP measurement & heart rate
• Fasting blood sugar, HbA1c and lipid profile
Suspected Obstructive Sleep Apnea (daytime • Measurement of neck circumference (>17 inches in men, >16 inches in women)
sleepiness, loud snoring, gasping or chocking • Polysomnograpy for oxygen desaturation, apnea and hypo-apneic events
episodes during sleep and awakening headaches ) • ENT examination for upper airway obstruction
Suspected Alveolar Hyperventilation (Pickwickian) • Polysomnography (to rule out obstructive sleep apnea)
syndrome (hypersomnolence, right sided heart • CBC to rule out polycythemia
failure including elevated JVP, hepatomegaly and • Blood gases (Pco2 often elevated)
lower limb edema • Chest x-ray (enlarged heart and elevated hemi-diaphragm)
• ECG: right atrial and right ventricular enlargement
• Pulmonary function test: reduced vital capacity and respiratory reserve volume
Suspected Hypothyroidism • TSH
Suspected Cushing's syndrome (moon face, thin skin • Elevated late night salivary cortisol level (>7 nmol/l diagnostic, 3-7 nmol/l
that bruise easily, severe fatigue, striae equivocal)
• Repeatedly elevated measurements of cortisol secretion (late night salivary
cortisol or urine free cortisol, upper normal 110-138 nmol/l)
Suspected Polycystic Ovarian Syndrome • Morning blood draw for total testosterone, free and weakly testosterone, DHEAS,
(oligomenorrhea, hirsutism, enlarged ovaries may be prolactin, TSH and early morning 17-hydroxyprogesteron
palpable, hypercholesterolemia, impaired glucose
tolerance, persistent acne and androgenic alopecia

Table 8 : The following questions can help in discussing readiness to change lifestyle behaviors:
• How important do you think it is for you to make changes at the moment?
• How confident are you that you can change your eating patterns and increase your physical activity to improve health?
• Are there any stressful events in your life now that might get in the way?
• Do you feel you can succeed in changing health behaviors’, and how much do you believe it is worth the effort?
• Can you picture yourself changing health behaviors? How do you think your friends and family will react to your efforts?
• Are there people who can support you to change health behaviors’? Do you think they will help you in your efforts?
22

Assess for readiness to change lifestyle behaviors


• Assess readiness for change in adults who are overweight or obese (NHMRC, evidence grade D)4.
• Inform all obese or overweight adults that modest or even minor weight reduction could bring health benefits
(NHMRC, evidence grade -D) including:
- Decreasing cardiovascular risk (reduced blood pressure and improved lipid profiles (NHMRC, evidence grade A)4.
- Preventing, delaying progression of, or improving control of type 2 diabetes (NHMRC, evidence grade A), kidney
disease, sleep apnea, musculoskeletal problems (NHMRC, evidence grade B), gastro-esophageal reflux or urinary
incontinence (NHMRC, evidence grade C)4.
- Improving quality of life, self-esteem and depression (NHMRC, evidence grade C)4.
• Life style modification e.g. physical exercise and reduced energy intake is likely to produce some health benefits
even without actual weight loss (NHMRC, evidence grade C)4.

Table 9: Assessment of overweight/obese patients 12


(Assessment helps to find answers to the following questions):
1- What is the class of obesity?
2- Is there any co-morbid condition? e.g. depression, eating disorders, sleep apnea, arthritis, or use of medications
3- Is it secondary obesity?
4- How much does the obesity affect the individual›s quality of life? e.g. mobility, self-esteem, socializing.
5- Is the individual aware of the health consequences of obesity, and benefit of treatment?
6- Has there been any attempt to lose weight? If so, why was it not effective?
7- Is the individual ready to start changing?
8- Is the individual a candidate for medication therapy or surgical interventions?
9- Is there any indication for specialist referral?
23

Figure 1: Stages of Change Model to Assess Readiness to Lose Weight15


24

Table 10: Applying the Stages of Change Model to Assess Readiness to Lose Weight15

Stages Characteristics Patient verbal cues Appropriate Sample dialogue


intervention
Pre-contemplation Unaware of problem; I am not really interested Provide information Would you like to read some
no interest in change in weight loss. It is not a about the health information about the health aspects
problem aspects of obesity of obesity
Contemplation Aware of problem, I know I need to lose Help resolve Let's look at the benefit of weight
beginning to think of weight, but with all that's ambivalence, discuss loss, as well as what you may need to
changing going on in my life right barriers change
now, I am not sure I can
Preparation Realizes benefits of I have to lose weight and I Teach behavior Let's take a closer look at how you can
making changes and am planning to do that modification; provide reduce some of the calories you eat
thinking about how to education
change
Action Actively taking steps I am doing my best; this is Provide support and It is terrific that you are working so
toward change harder than I thought guidance, with a focus hard. What problems have you had so
on the long term far? How have you solved them?
Maintenance Initial treatment goals I've learned a lot through Relapse control What situations continue to tempt you
reached this process to over eat? What can be helpful for the
next time you face such a situation?
25

Management of obesity

Devise goals:

• The ultimate goal of weight management is to improve health and to reduce the risk of obesity related co-
morbidities 11.
- For adults with BMI 25-35 kg/m2 the target is to lose 5-10% of body weight (0.5-1 kg per week)3,11.
- For adults with BMI>35 kg/m2 and obesity-related co-morbidities the target is to lose a greater than 15-20% of
body weight 11.

Devise life style modification program for weight loss and reduction of risk factors:

• The focus of life style modification goals should be on improving health rather than reducing weight 4.
• Lifestyle modification should target at reducing energy intake, increasing energy expenditure and assisting in
behavioral change (NHMRC, evidence grade A) 4.
• Optimal dietary plan for achieving healthy body weight should be developed with a qualified and experienced
health professional team together with the individual and family 11.
• On discussing weight management with the patient and family, health professionals are encouraged to create a
nonjudgmental atmosphere and to address barriers to weight management (Canadian, evidence grade C, level 4) 3.

Dietary interventions
• Target energy deficit of 500-1000 kilo-calorie per day (3,500 kcal/week). Attention should be given to the dietary
preferences of the individual (NHMRC, evidence grade A) 4.
• Provide advice on dietary modification appropriate to the patient condition (type, quantity and/or frequency) to
achieve and maintain a hypo-caloric intake (a high-protein or a low-fat diet with acceptable macronutrient
distribution range). Patients should be advised to:
26

- choose low energy-dense foods (e.g. whole-grains, cereals, fruits, vegetables, and salads) and reduce intake of
energy-dense foods (e.g. animal fats, sugary drinks (SIGN, evidence grade B) 11.
- reduce consumption of junk food 11.
- undertake regular self-weighing (SIGN, evidence grade B) 11.
• Strictly supervise patients on very low calorie diets prescribed for rapid weight loss, (SIGN, evidence grade D) 11.

Physical activity in adults


• Encourage overweight or obese individuals to be physically active and to avoid sedentary behavior (SIGN, evidence
grade B) 11.
• Prescribe a volume of physical activity that produce energy deficit of approximately 1,800-2,500 kcal/week. This
could be achieved through 5 sessions of 45-60 min/week of moderate intensity physical activity, or lesser amounts
of vigorous physical activity (SIGN, evidence grade B) 11, however, the individuals can perform multiple small
sessions of at least 10 minutes duration during the day to accumulate the required physical activity volume 11.
• Clinically assess the individual physical fitness to perform the required physical exercise 11.
• Build up the pace of physical activity gradually over time. The volume of physical exercise should be sustainable and
tailored to the individual condition (Canadian, evidence grade A, level 2) 3 :
- sedentary individuals should start with 10-20 min of physical activity every other day during the first 2 weeks 11.
- vigorous intensity activity should be introduced gradually after an initial 4-12 week period of moderate intensity
activity 11.
- encourage non-weight-bearing moderate intensity physical activities (e.g. cycling, swimming, water aerobics) for
obese patients suffering from joint problems (BMI over 35 kg/m2) 11.
- brisk walking can be classified as moderate intensity physical activity in obese individuals. Walking one km (0.62
miles) on flat ground burns approximately 60 kcal for a 70 kg person and 90 kcal for a 100 kg person11 .
27

Psychological/behavioral interventions

• Psychological interventions should be part of any weight management program (SIGN, evidence grade A) 11.
• It should be adjusted to circumstances of the individuals or their families. The objectives are to decrease dietary
energy intake, increasing physical activity, and decreasing sedentary behaviors (SIGN, evidence grade B) 11.

Table 11: Psychological Interventions & Strategies


• The range of appropriate psychological interventions and strategies includes:
- Self-monitoring of behavior and progress.
- Stimulus control (where the patient is taught how to recognize and avoid triggers
that prompt unplanned eating).
- Cognitive restructuring (modifying unhelpful thoughts/thinking patterns).
- Goal setting.
- Problem solving.
- Assertiveness training.
- Slowing the rate of eating.
- Reinforcement of changes.
- Relapse prevention.
- Strategies for dealing with weight regain.

Source: (SIGN, 2010)


28

Long-term weight management:

• Devise strategies appropriate to specific individual situations to prevent or minimize weight regain in adults who
successfully achieved weight loss (NHMRC, evidence grade A) 4.
• Advise the adults who successfully achieved weight loss, to consult health professionals if they observed small
amount of weight regain (approximately 3 kg). Health professionals should reassess the lifestyle modification
maintenance program for the individual (NHMRC, evidence grade PP) 4.
• Encourage motivation for long-term weight management through approaches including self-management (e.g.
manage hunger, reviewing goals, and regular self-weighing), continuing contact with health professionals and
behavioral strategies (NHMRC, evidence grade PP) 4.

Referral for specialist support:


• Pharmacologic treatment may be considered as an adjunct to lifestyle interventions in individuals with BMI >30 kg/
m2 or BMI >28 kg/m2 with co-morbidities or in adults who are not attaining, or who are unable to maintain clinically
important weight loss with dietary and exercise therapy (Canadian, evidence grade B, level 2, SIGN evidence grade
A) 3,4.
• Refer for specialist services if needed for co-morbidities such as musculoskeletal, physiological, endocrinological,
sleep apnea and type 2 diabetes (NHMRC, evidence grade D) or when a very low-energy diet is recommended 4.
• Refer when bariatric surgery is a consideration 4:
- Adults with BMI > 40 kg/m2.
- Adults with BMI > 35 kg/m2 and co-morbidities not adequately improved with the lifestyle intervention.
- Adults with a BMI > 30 kg/m2 with poorly controlled type 2 diabetes and high risk of cardiovascular diseases.
29

Chapter 4

PHARMACOLOGICAL TREATMENT
30

PHARMACOLOGICAL TREATMENT:

Currently there is a list of medications used for pharmacological treatment (see table 12), however, there is no enough
evidence regarding the efficacy of different drugs, the benefit of combination therapy, weight regain after withdrawal
of medications or the benefits of continuing treatment beyond 1 year. However, the following are recommended 11,16:
• Consider adding pharmacologic agent with lifestyle interventions on an individual case basis after assessment of
risks and benefits:
- In obese adults (BMI ≥30 kg/m2) who failed to achieve or maintain weight loss with lifestyle modification program,
(Canadian, evidence grade B level 23 and SIGN, Evidence grade A) 11.
- In obese or overweight individuals (BMI ≥28 kg/m2 with co-morbidities) to assist in reducing obesity-related co-
morbidities, like type 2 diabetes, impaired glucose tolerance or the risk factors for type 2 diabetes (Canadian,
evidence grade B level 23 and SIGN, Evidence grade A) 11.
- In pre-pubertal obese children Pharmacological therapy is generally not recommended, however, it can be
considered only (treatment with Orlistat) under supervision of specialized team, if severe co-morbidities are
present, e.g. orthopedic problems, sleep apnea, severe psychological disease or within the context of a supervised
clinical trial (Canadian, evidence grade C, level 4 and NICE, 2006, amended 2014) 3,17.
• Discuss with the patient the potential benefits, limitations, drug’s side effects, and the temporary nature of the
weight loss achieved with medications before initiating therapy (NICE, 2006, amended 2014) 17.
• Discontinue use if the drug is ineffective, or if there are serious adverse effects 18.
31

Table 12: Characteristics of Anti-Obesity Medications 19-25


Active Ingredient Lorcaserin HCl Naltrexone HCl and Phentermine and topiramate Extended-release Liraglutide* Orlistat*
buproprion HCl extended extended-release
release
Class Serotonin 2C Opioid antagonist Sympathomimetic amine anorectic GLP-1 receptor agonist Reversible gastrointestinal
receptor agonist and amino ketone and anti epileptic drug lipase inhibitor
antidepressant
Mechanism of Selective Regulation of food Likely mediated by release Directly activates GLP- Exerts activity in the lumen
Action activation intake through effect of catecholamines in the 1receptors to mimic the action of the stomach and small
of 5-HT2C on hypothalamus and hypothalamus, resulting in reduced of native GLP-1. Regulates intestine by forming a
receptors on mesolimbic dopamine appetite and decreased food appetite and decreases caloric covalent bond with the active
anorexigenic pro- circuit. consumption. Exact mechanism is intake serine residue site of gastric
opiomelanocortin unknown(phentermine)Potential and pancreatic lipases. The
neurons in the effect on appetite suppression inactivated enzymes become
hypothalamus and satiety enhancement, induced unavailable to hydrolyze
to decrease food by a combination of augmenting dietary fat in the form of
consumption and activity of gamma aminobutyrate, triglycerides into absorbable
promote satiety modulation of voltage-gated ion free fatty acids and mono-
channels, inhibition of AMPA/kainite glycerides
excitatory glutamate receptors, or
inhibition of carbonic anhydrase.
Exact mechanism known(topiramate)
Half-Life ~11 hours ~5 hours (naltrexone)~21 ~20 hours (phentermine)~65 hours 13 hours 1-2 hours (parent drug)~3
hours (buproprion) (topiramate) hours (M1 metabolite)~13.5
hours (M3metabolite)
Metabolism Extensive hepatic Metabolism to active p-hydroxylation on the aromatic ring Metabolized by endogenous Two main metabolites,
metabolism by metabolite 6-beta- and Noxidationon the aliphatic chain. peptidases in a similar way to M1(hydrolyzed β-lactone ring
multiple naltrexol(naltrexone). Primarily CYP3A4 but not extensively large proteins product) and M3 (sequential
enzymatic Extensive metabolism to metabolized (phentermine). Not metabolite after M1’scleavage
pathways three active metabolites: extensively metabolized. of the N-formylleucine side-
hydroxybupropion Metabolism to 6 metabolites via chain)
(viaCYP2B6), hydroxylation, hydrolysis, and
threohydrobupropion, and glucuronidation (topiramate)
erythrohydrobupropion
(bupropion)
32

Active Ingredient Lorcaserin HCl Naltrexone HCl and Phentermine and topiramate Extended-release Liraglutide* Orlistat*
buproprion HCl extended extended-release
release
Route of Primarily renal Primarily renal Primarily renal No single organ as major route Primarily fecal excretion of
Elimination of elimination unabsorbed drug
Limitations of Use • Safety and • Effect on CV morbidity • Effect on CV morbidity andmortality • Should not be used in
efficacy of co- and mortality has not has not beenestablished combination with any
administration been established • Safety and effectiveness in otherGLP1- receptor agonist
with other • Safety and effectivenessin combination with other products • Should not be used with
products for combination with other for weight loss, including insulin
weightloss products for weight loss, prescription and OTC drugs, and • Effect on CV morbidity and
have not been including prescription herbal preparations have not been mortality have not been
established and OTC drugs, and established established
• Effect on CV herbal preparations have • Safety and efficacy of co-
morbidity and not been established administration with other
mortality has not products for weight loss have
been established not been established
• Not been studied in patients
with a history of pancreatitis

Contraindications Pregnancy • Uncontrolled • Pregnancy Personal or family history of Pregnancy, chronic mal-
hypertension • Glaucoma MTC or MEN2,hypersensitivity absorption syndrome,
• Seizure disorders, • Hyperthyroidism to liraglutide cholestasis, known
anorexia nervosa or • during or within 14 days of taking or any product components, hypersensitivity to the
bulimia, or undergoing MAOIs pregnancy medication or to any product
abrupt discontinuation of • known hypersensitivity or components
alcohol, benzodiazepines, idiosyncrasy to sympathomimetic
barbiturates, and amines
antiepileptic drugs
• Use of other bupropion
containing products
• Chronic opioid use
• During or within 14 days
of taking MAOIs
• Known allergy to any
ingredients in the product
• Pregnancy
33

Active Ingredient Lorcaserin HCl Naltrexone HCl and Phentermine and topiramate Extended-release Liraglutide* Orlistat*
buproprion HCl extended extended-release
release
Maintenance 10 mg oral BID, The dose should be 7.5 mg/46 mg oral QD every morning 3 mg SC QD at any time of 120 mg oral TID with each
Dosage and with or without escalated starting with with or without food the day, independent of main meal containing
Administration food. Discontinue 1tablet in the morning. Maximum dose is 15 mg/92 meals. Discontinue if patient fat(during or up to 1 hour
if patient has A total dosage of two Mg has not lost ≥4% of baseline after the meal)
not lost ≥5% of 8mg/90 mg tablets oral Discontinue or escalate the dose bodyweight by week 16
baseline body BID in the morning and if the patient has not lost ≥3% of
weight by week evening is reached at the baseline body weight by week 12 on
12 start of Week 4. 7.5mg/46 mg dosage, If the patient
Should not be taken with a has not lost ≥5% of baseline body
high fat meal. Discontinue weight on 15 mg/92 mg dosage after
if patient has not lost ≥5% an additional 12 weeks discontinue
of baseline body weight by treatment
week 12
Warnings and Serotonin • Suicidal behavior and • Fetal toxicity • Risk of thyroid C-cell tumors • Can decrease cyclosporine
Precautions syndrome or thoughts • Increase in HR • Acute pancreatitis exposure
neuroleptic • Risk of seizure may be • Suicidal behavior and thoughts • Acute gallbladder disease • Patient should be strongly
malignant minimized by adhering • Acute myopia and secondary angle • Risk of hypoglycemia with encouraged to take
syndrome-like to recommended dosing closure glaucoma concomitant use of anti- multivitamin supplement
reactions schedule and avoiding • Mood and sleep disorders diabetic therapy that contains fat-soluble
• Valvular heart co-administration with • Cognitive impairment • Heart rate increase vitamins
disease high-fat meal • Metabolic acidosis • Renal impairment • Rare cases of severe liver
• Cognitive • Increase in BP and HR • Elevated creatinine • Hypersensitivity reactions injury with hepatocellular
impairment • Hepato-toxicity • Use of anti-diabetic medications • Suicidal behavior and necrosis or acute hepatic
• Psychiatric • Angle-closure glaucoma thoughts failure have been reported
disorders, • Use of anti-diabetic • Patients may develop
including medications increased levels of urinary
euphoria and oxalate following treatment.
dissociation Monitor renal function
• Monitor for in patients at risk for renal
depression or insufficiency
suicidal thoughts • Substantial weight loss can
• Use of anti- increase risk of cholelithiasis
diabetic • Exclude organic causes of
medications obesity before prescribing
• Priapism • GI events may increase when
orlistat is taken with a high
at diet (>30%total daily
calories from fat)
34

Active Ingredient Lorcaserin HCl Naltrexone HCl and Phentermine and topiramate Extended-release Liraglutide* Orlistat*
buproprion HCl extended extended-release
release
Common Adverse Non-diabetic Nausea, constipation, Paraesthesia, dizziness, dysgeusia, Nausea, hypoglycemia, Oily spotting, flatus with
Reactions patients: headache, vomiting, insomnia, constipation, and dry diarrhea, constipation, discharge, fecal urgency fatty/
Headache, dizziness, insomnia, dry mouth vomiting, headache, decreased oil stool, oily evacuation,
dizziness, fatigue, mouth, and diarrhea appetite, dyspepsia, fatigue, increased defecation and fecal
nausea, dry dizziness, abdominal pain incontinence
mouth, and
constipation
Diabetic patients:
Hypoglycemia,
headache, back
pain, cough, and
fatigue

How Supplied 10 mg tablets 8 mg/90 mg tablets 3.75 mg/23 mg, 7.5 mg/46 Disposable, pre-filled, multi- 120 mg capsules
mg, 11.25 mg/69 mg and 15mg/92 dose pen that delivers 0.6mg,
mg capsules 1.2 mg, 1.8 mg, 2.4 mg or 3 mg
(6 mg/mL, 3mL).
Storage Store at 77°F Store at 77°F (25°C), Store at 59-77°F (15-25°C) Unopened pens: store in the Store at 77°F (25°C),with
(25°C), with permitted excursions refrigerator between 36-6°F permitted excursions of59-
with permitted of 59-86°F (15-30°C) (2-8°C) 86°F (15-30°C)
excursions of In-use pens: store in the
59-86°F (15-30°C) refrigerator 36-46°F (2-8°C)
OR at room temperature
between 59-86°F (15-30°C)
After initial use, the Liraglutide
3mg pen must be used within
30 days

GLP-1: glucagon-like peptide-1; AMPA: α-amino-3-hydroxyl-5-methyl-4-isoxazole-propionate; BMI: body mass index; HTN: hypertension; CV: cardiovascular; OTC:
over-the-counter; MAOI: monoamine oxidase inhibitors; MTC: medullary thyroid carcinoma; MEN2: Multiple Endocrine Neoplasia syndrome type 2; BID: twice daily;
QD: once daily; SC: subcutaneously; TID: three times daily; BP: blood pressure; HR: heart rate; GI: gastrointestinal

*Only Orlistat and LiraglutideBSFUIFPOMZ registered drugs in the Saudi Food & Drug Authority
35

Chapter 5

BARIATRIC SURGERY
36

BARIATRIC SURGERY:
• Consider Bariatric surgery as part of an overall clinical pathway for adult weight management.(SAGES evidence level I,
grade A) 26.
• Consider bariatric surgery on an individual case basis after assessing the risks and benefits (SIGN, evidence grade C) 11.
• Consider bariatric surgery:
- In adults with clinically severe obesity (BMI > 40 kg/m2). It is the most effective treatment for morbid obesity, it leads
to durable weight loss and improvement of co-morbidities (SAGES evidence level I, grade A) 26.
- In adults with BMI > 35 kg/m2 and severe co-morbidities (SIGN, evidence grade C3 and Canadian, evidence grade B,
level 2) 11.
- In adults with BMI > 30 kg/m2 who have poorly controlled type 2 diabetes and are at increased cardiovascular risk
(NHMRC, evidence grade PP) 4.
- In post pubertal adolescents with very severe to extreme obesity and severe co-morbidities (SIGN, evidence grade
D)11. Bariatric surgery in adolescents is to be limited to exceptional cases and performed only by experienced teams
(Canadian, evidence grade C, level 4) 3.
• It should be performed by an experienced and well trained multidisciplinary team, including surgeons, anesthetists,
dietitians, nurses, psychologists and physicians (SAGES evidence level III, grade C). However, types of surgery,
anesthetic practice and immediate post-operative care are out of the scope of these guidelines 26.
• Assess for psychological disorders preoperatively (SAGES evidence level III, grade C). Treated psychopathology does
not prevent patients to undergo bariatric surgery (SAGES evidence level II, grade B) 26.
• Intra-gastric balloon is a safe and effective procedure in weight reduction, but, unfortunately, the results are temporal
and almost all patients return to their initial weights after balloon removal 27,28.
37

Table 13: Common types of bariatric surgery 29


Treatment General Potential acute complications Potential chronic complications
Sleeve • Hospital stay 1-2 days • Postoperative complications are • Weight regain
Gastrectomy • Recovery 1-2 weeks rare • Marginal ulcer
• Contraindications • Hemorrhage • Dumping syndrome with reactive
- Poor surgical candidates • Anastomotic staple line leak hypoglycemia
- Sever psychiatric disorder • Deep vein thrombosis • Luminal stenoses (stomal narrowing)
- Intolerance to general anesthesia • Pulmonary emboli • Anastomotic staple line leak
- Pregnancy • Dehydration • Fistula formation
- Drug or alcohol addiction • Death • Iron deficiency
- Untreated or sever esophagitis • Protein malnutrition
- Barrett›s esophagus • Other nutritional and mineral deficiencies
- Sever gastroparesis (e.g. deficiencies of vitamins A, C, D, E, B
- Achalasia and K, folate, zinc, magnesium, thiamine,
- Previous gastrectomy etc.)
• Sometimes used as staged approach to • Anemia (often related to mineral and
gastric by-pass nutrition deficiencies)
• Neuropathies (resulting from nutritional
deficiencies)
• Osteoporosis (often caused by calcium
deficiencies and chronically elevated
parathyroid hormone levels)
• Potential need to re-operate
Laparoscopic • Outpatient procedure • Band too tight with • Weight regain
adjustable • Recovery usually one week gastrointestinal obstructive • Band slippage, erosion ulceration, port
gastric • Contraindications symptoms (e.g. dysphagia) infection, disconnection and displacement
banding - Poor surgical candidates • Leakage of gastric content into • Esophageal dilation
- Sever psychiatric disorder abdomen • Rare nutrient deficiencies if persistent
- Intolerance to general anesthesia • Hemorrhage vomiting or marked and sustained
- Pregnancy • Deep vein thrombosis decrease in nutritional intake
- Drug or alcohol addiction • Death • Depression
- Untreated or sever esophagitis • Potential need to re-operate
• GERD
38

Treatment General Potential acute complications Potential chronic complications


Gastric bypass • Hospital stay 2-4 days • Gastrointestinal obstruction • Weight regain
• Recovery 2-4 weeks • Hemorrhage • Marginal ulcer
• Contraindications • Anastomotic leaks • Esophageal dilation
- Poor surgical candidates • Deep vein thrombosis • Dumping syndrome with reactive
- Sever psychiatric disorder • Pulmonary emboli hypoglycemia
- Intolerance to general anesthesia • Dehydration • Small bowel obstruction caused by
- Pregnancy • Death internal hernias or adhesions
- Drug or alcohol addiction • Anastomotic stenoses (stomal narrowing)
- Untreated esophagitis • Calcium deficiency
- Unwillingness or an inability for • Secondary hyperparathyroidism
appropriate long-term follow-up • Iron deficiency
• Protein malnutrition
• Other nutritional and mineral deficiencies
(e.g. deficiencies of vitamins A,C,D,E,B and
K, folate, zinc, magnesium, thiamine, etc.)
• Anemia (often related to mineral and
nutrition deficiencies)
• Metabolic acidosis
• Bacterial overgrowth
• Kidney stones (oxalosis)
• Neuropathies (resulting from nutritional
deficiencies)
• Osteoporosis (often caused by calcium
deficiencies and chronically elevated
parathyroid hormone levels)
• Depression
Potential need to re-operate
39

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43

ANNEXES:

ANNEX 1: KEY TO EVIDENCE STATEMENTS AND GRADES OF RECOMMENDATIONS:

1 - Level of evidence and grade of recommendations used by Scottish Intercollegiate Guidelines Network (SIGN).
Levels of evidence
1++ High quality meta-analyses, systematic reviews of RCTs or RCTs with a very low risk of bias
1+ Well-conducted meta-analyses, systematic reviews or RCTs with a low risk of bias
1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias
2++ High quality systematic reviews of case control or cohort studies/high quality case control or cohort studies with a very low risk
of confounding or bias and a high probability that the relationship is causal
2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the
relationship is causal
2- Case control or cohort studies with a high-risk of confounding or bias and a significant risk that the relationship is not causal
3 Non-analytic studies, e.g., case reports, case series
4 Expert opinion
Grades of recommendation
A At least one meta-analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population;
or A body of evidence consisting principally of studies
rated as 1+, directly applicable to the target population,
and demonstrating overall consistency of results
B A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating
overall consistency of results; or extrapolated evidence from studies rated as 1++ or 1+
C A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating
overall consistency of results; or extrapolated evidence from studies rated as 2++
D Evidence level 3 or 4; or extrapolated evidence from studies rated as 2+
RCT: Randomized controlled trials

RCT: Randomized controlled trials


44

2 - Grade of recommendations used by National Health and Medical Research Council (NHMRC) - Australia

Grade Description
A Body of evidence can be trusted to guide the practice
B Body of evidence can be trusted to guide the practice in most situations
C Body of evidence provides some support for recommendation(s) but care should be taken in its application
D Body of evidence is weak and recommendation must be applied with caution
CBR Consensus-based recommendation formulated in the absence of quality evidence
PP Developed by the Obesity Guidelines Development Committee for areas beyond the scope of the systematic review.

3 - Classification of evidence used in the 2006 Canadian clinical practice guidelines on the management and prevention of
obesity in adults and children

Level of evidence Criteria


1 • Randomized controlled trials (or meta-analyses) without important limitations
2 • Randomized controlled trials (or meta-analyses) with important limitations
• Observational studies (nonrandomized clinical trials or cohort studies) with overwhelming evidence
3 • Other observational studies (prospective cohort studies, case–control studies, case series)
4 • Inadequate or no data in population of interest
• Anecdotal evidence or clinical experience
45

Criteria
Level of for assigning a grade to recommendations
Grade Criteria
A Strong recommendation (action can apply to most individuals in most circumstances)
• benefits clearly outweigh risks (or vice versa)
• evidence is level 1, 2 or 3
B Intermediate recommendation (action may vary depending on the person’s characteristics or other circumstances)
• unclear whether benefits outweigh risks
• evidence is level 1, 2 or 3
C Consensus (weak) recommendation (alternative actions may be equally reasonable)
• unclear whether benefits outweigh risks
• evidence is level 3 or 4

4 - Definition of grades of recommendations used by Institute for Clinical Systems Improvement (ICSI), Minnesota (USA)
Category Quality Definitions Strong Recommendation Weak Recommendation
High Quality Further research is very unlikely The work group is confident that The work group recognizes that the
Evidence to change our confidence in the the desirable effects of adhering to evidence, though of high quality, shows a
estimate of effect this recommendation outweigh the balance between estimates of harms and
undesirable effects. This is a strong benefits. The best action will depend on local
recommendation for or against. This circumstances, patient values or preferences.
applies to most patients
Moderate Further research is likely to The work group is confident that The work group recognizes that there is a
Quality have an important impact on the benefits outweigh the risks but balance between harms and benefits, based
Evidence our confidence in the estimate recognizes that the evidence has on moderate quality evidence, or that there is
of effect and may change the limitations. Further evidence may uncertainty about the estimates of the harms
estimate. impact this recommendation. This is a and benefits of the proposed intervention that
recommendation that likely applies to may be affected by new evidence. Alternative
most patients. approaches will likely be better for some
patients under some circumstances.
Low Quality Further research is very likely to The work group feels that the evidence The work group recognizes that there is
Evidence have an important impact on consistently indicates the benefit of significant uncertainty about the best
our confidence in the estimate this action outweighs the harms. This estimates of benefits and harms.
of effect and is likely to change. recommendation might change when
The estimate or any estimate of higher quality evidence becomes
effect is very uncertain. available.
46

5 - Definition of grades of recommendations used by the Society of American Gastrointestinal and Endoscopic
Surgeons(SAGES)
Level of evidence Criteria
Level I Evidence from properly conducted randomized controlled trials
Level II Evidence from controlled trials without randomization
Or Cohort or case-control studies Or Multiple time series, dramatic uncontrolled experiments
Level III Descriptive case series, opinions of expert panels

Scale used for recommendation grading


Grade Description
Grade A Based on high-level (level I or II), well performed studies with uniform interpretation and conclusions by expert panel
Grade B Based on high-level, well-performed studies with varying interpretation and conclusion by the expert panel
Grade C Based on lower-level evidence (level II or less) with inconsistent findings and/or varying interpretations or conclusions by
the expert panel
47

ANNEX 2: MEMBERS OF ADOPTION GROUP OF FIRST DRAFT OF THE GUIDELINES:

The members of the adoption group of first version of the Clinical Saudi Obesity Guidelines.

• Fahad S. Al-Shehri, Consultant of Family Medicine, Department of Family Medicine and Research, Health Affairs,
Aseer Region,

• Mohammed M. Moqbel, Consultant of family medicine, Department of Family Medicine and Research, Health Affairs,
Aseer Region,

• Abdullah M. Al-Shahrani, Departments of Family Medicine and Public Health, Ministry of Health Affairs, Southern
Region

• Yahia M. Al-Khaldi, Department of Family Medicine and Research, Health Affairs, Aseer Region,

• Waleed S. Abu-Melha, Department of Preventive Medicine, Armed Forced Hospital, Southern Region, Saudi Arabia
48

ANNEX 3: OBESITY CONTROL PROGRAM SCIENTIFIC COMMITTEE:

• Prof. Aayed R. Alqahtani - MD, FRCSC, FACS, Director of KSU Obesity Chair, Professor of Bariatric and MIS Surgery,
College of Medicine, King Saud University

• Dr. Adnan A. Sabbahi - Consultant General, Laparoscopic & Bariatric Surgeon

• Dr. Alhasan M. Alkaud -Family and Bariatric Medical Consultant

• Dr Fahad Shar Alshehri - Consultant of family medicine and diabetes, Member of Saudi Arabian Society of Metabolic
& Bariatric Surgery (SASMBS)

• Dr. Haitham Alfalah, Consultant Bariatric Surgery, Kind Saud Medical City, Riyadh

• Dr. Khalid I. Alqumaizi - Consultant Family and Community Medicine, Dean, College of Medicine, ImamU

• Dr. Mohammad Y. Saeedi -Consultant Family and Community Medicine -Director General for Genetic and Chronic
Diseases , MOH , KSA

• Dr. Mohammed Y. Alharbi - Consultant of Pediatric Endocrinology, Dialectology and Obesity, Director of Diabetes
Centers and units Administration ,MOH, KSA

• Prof. Mourad Elmourad - Consultant Endocrinologist, Senior Advisor for Genetics & Chronic Directorate, MOH

• Dr. Mustafa Salih Mustafa, MBBS, MD Community Medicine, MA Health Management, Policy and Planning, General
Directorate for Genetic and Chronic Diseases , MOH , KSA

• Dr. Omar A. Alobaid - Associate Professor of Surgery, College of Medicine, King Saud University.
49

• Dr. Saleh M. AlRajhi - , DO, FAAFP, EMHA Candidate Bariatric and Family medicine consultant ,Chairman of Obesity
Department Obesity Metabolic And Endocrine Center ,King Fahad Medical City Riyadh, KSA

• Dr. Shaker A. Alomary - Consultant Family Medicine -Director of Obesity Control Program , MOH , KSA

ANNEX 4: GUIDELINES PREPARATION COMMITTEE:

• Dr. Shaker A. Alomary - Consultant Family Medicine -Director of Obesity Control Program , MOH , KSA

• Dr. Mustafa Salih Mustafa, MBBS, MD Community Medicine, MA Health Management, Policy and Planning, General
Directorate for Genetic and Chronic Diseases , MOH , KSA

• Dr. Syed Arif Hussain, MBBS, DPH, MSc Epidemiology, Epidemiologist/Public Health Specialist, General Directorate for
Genetic and Chronic Diseases , MOH , KSA

• Dr. Yassin Hassan Alsafi, MBBCH,MRCGP, General Directorate for Genetic and Chronic Diseases , MOH , KSA

• Dr. Mohamed E. Ibrahim - MBBS, Mph, MPhil Clinical Epidemiology, General Directorate for Genetic and Chronic
Diseases , MOH , KSA

• Dr. Fahad A. Alamri - Consultant Family Medicine, General Directorate for Genetic and Chronic Diseases , MOH , KSA

• Dr. Ahmed Jafar Al Eid, BSc, MD, SDFM, EMHCA. Family Physician, Coordinator of Obesity Control Program in Eastern
Province, MOH, KSA

• Muteb Z. Almalki-Nutrition technician

• Talal F. Almoreished- Puplic Health Specialist


50

ANNEX 5: CHARTS FOR BMI TO AGE PERCENTILES AMONG CHILDREN

BMI for age-percentiles: boys, birth to 36 months 43 x 55 mm BMI for age-percentiles: boys, 2 to 19 years 43 x 55 mm
Source: Al Herbish AS, El Mouzan MI, Al Salloum AA, Al Qureshi MM, Al Omar AA, Foster PJ, Kecojevic T. Body mass index in Saudi Arabian children and adolescents: a national reference and
comparison with international standards.
51

BMI for age-percentiles: girls, birth to 36 months BMI for age-percentiles: girls, 2 to 19 years

Source: Al Herbish AS, El Mouzan MI, Al Salloum AA, Al Qureshi MM, Al Omar AA, Foster PJ, Kecojevic T. Body mass index in Saudi Arabian children and adolescents: a national reference and
comparison with international standards.
For any inquiries or suggestions please feel free to contact us at: OCP@moh.gov.sa

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