Prevention of Diabetes Self-Management Program (PREDIAS): Effects on Weight, Metabolic Risk Factors, and Behavioral Outcomes

Clinical Care/Education/Nutrition/Psychosocial Research B R I E F R E P O R T Prevention of Diabetes Self-Management Program (PREDIAS): Effects on Weight, Metabolic Risk Factors, and Behavioral Outcomes BERNHARD KULZER, PHD1 NORBERT HERMANNS, PHD1 DANIELA GORGES, MA1 PETER SCHWARZ, MD2 THOMAS HAAK, PHD1 OBJECTIVE — To evaluate the efficacy of the group program PREDIAS for diabetes prevention. RESEARCH DESIGN AND METHODS — PREDIAS consists of 12 lessons and aims at lifestyle modification. The control group received written information about diabetes prevention. In this study, a total of 182 persons with an elevated diabetes risk participated (aged 56.3 ⫾ 10.1 years, 43% female, and BMI 31.5 ⫾ 5.3 kg/m2). RESULTS — After 12 months, weight loss was significantly higher (P ⫽ 0.001) in PREDIAS than in the control group (⫺3.8 ⫾ 5.2 vs. ⫺1.4 ⫾ 4.09 kg). There were also significant effects (P ⫽ 0.001) on fasting glucose (control group 1.8 ⫾ 13.1 mg/dl vs. PREDIAS ⫺4.3 ⫾ 11.3 mg/dl), duration of physical activity per week (control group 17.9 ⫾ 63.8 min vs. PREDIAS 46.6 ⫾ 95.5 min; P ⫽ 0.03), and eating behavior. CONCLUSIONS — PREDIAS significantly modified lifestyle factors associated with an elevated diabetes risk. Diabetes Care 32:1143–1146, 2009 T he prevalence of type 2 diabetes is increasing worldwide. Diabetes is associated with an increased risk for morbidity and mortality (1,2). Metaanalyses have shown that type 2 diabetes can be effectively prevented or delayed by lifestyle modification (3,4). We developed a group program (PREDIAS) for the prevention of type 2 diabetes that is based on the Diabetes Prevention Program (5,6). The aim of this randomized controlled trial was to evaluate in a 12-month follow-up the efficacy of PREDIAS with regard to the primary outcome variable, weight reduction, as well as behavioral, metabolic, and psychological outcomes as secondary variables. RESEARCH DESIGN AND METHODS — PREDIAS was compared with a control group whose members received the PREDIAS group intervention written information and patient materials. Inclusion criteria were those aged 20 –70 years with BMI ⱖ26 kg/m2, impaired glucose tolerance or impaired fasting glucose, and an ability to read and understand German. Exclusion criteria were manifest diabetes or diagnosis of a serious illness (e.g., cancer). All patients gave informed consent. The study was approved by the local ethics committee. Individuals with an elevated diabetes risk based on a high score (⬎10) on the Diabetes Risk Score (7) or according to the assessment of a primary care physi- ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● From the 1Research Institute of the Diabetes Academy Mergentheim and Diabetes Centre Mergentheim, Bad Mergentheim, Germany; and the 2Department of Medicine, University of Dresden, Carl Gustav Carus, Dresden, Germany. Corresponding author: Norbert Hermanns, hermanns@diabetes-zentrum.de. Received 2 December 2008 and accepted 6 March 2009. DOI: 10.2337/dc08-2141. Clinical trial reg. no. NCT00707447, clinicaltrials.gov. © 2009 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons. org/licenses/by-nc-nd/3.0/ for details. The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact. DIABETES CARE, VOLUME 32, NUMBER 7, JULY 2009 cian were invited to a baseline examination. After a pool of 12–20 patients was created, a centrally performed block randomization (1:1) assigned subjects randomly to the PREDIAS or the control group. The results refer to changes between baseline and the 12-month follow-up measurement. Patients underwent an oral glucose tolerance test. Weight, height, waist circumference, and blood pressure were assessed by study nurses, who were blinded to the treatment assignment of the subjects. Also, lipids and A1C were measured. Glucose was measured from capillary blood samples. Physical activity was assessed by a physical activity questionnaire used in a representative federal health survey in Germany (8). Physical activity is reported as minutes per week. The Three Factor Eating Questionnaire, with the three scales cognitive restraint of eating, disinhibition, and hunger, was used to measure psychological determinants of eating behavior (9,10). Trait anxiety was measured by the State-Trait Anxiety Inventory (11). High scores on the scales always indicate a high parameter value. The World Health Organization-Five Well-Being Index (WHO-5) assessed psychological well-being (12), and the Center for Epidemiologic Studies Depression Scale (CES-D) measured depressive symptoms (13). Low scores on the WHO-5 indicate reduced psychological well-being, whereas high scores on the CES-D indicate elevated depressive symptoms. Statistical analysis A power analysis showed that, assuming an additional weight reduction of 2.5 ⫾ 4.6 kg and a power of 1⫺␤ ⫽ 0.90 (two– sided ␣ ⫽ 0.05), 73 participants per group were appropriate. Calculating with a nonevaluable rate of maximum 20%, a total of 182 individuals (91 in each treatment group) was needed. An intention-to-treat analysis was performed using the baseline observation carried forward method. Statistical analy1143 Efficacy of a diabetes prevention group program Table 1—Baseline and 12-month follow-up results in the control group and the PREDIAS group PREDIAS Between-group P-value 32.0 ⫾ 5.7 31.5 ⫾ 5.8 ⫺0.5 ⫾ 1.4 (P ⫽ 0.002)* 31.0 ⫾ 4.7 29.7 ⫾ 4.7 ⫺1.3 ⫾ 1.7 (P ⬍ 0.001)* 0.002 93.6 ⫾ 19.3 92.2 ⫾ 19.4 ⫺1.4 ⫾ 4.0 (P ⫽ 0.002)* 92.1 ⫾ 16.5 88.3 ⫾ 15.9 ⫺3.8 ⫾ 5.2 (P ⬍ 0.001)* 0.001 106.3 ⫾ 13.7 105.9 ⫾ 14.1 ⫺0.4 ⫾ 6.2 (P ⫽ 0.559)* 106.8 ⫾ 13.7 102.7 ⫾ 12.5 ⫺4.1 ⫾ 6.0 (P ⬍ 0.001)* 0.001 105.5 ⫾ 12.4 107.3 ⫾ 14.3 1.8 ⫾ 13.1 (P ⫽ 0.211)* 105.7 ⫾ 12.4 101.4 ⫾ 11.3 ⫺4.3 ⫾ 11.3 (P ⫽ 0.001)* 0.001 138.5 ⫾ 34.9 130.3 ⫾ 36.1 ⫺8.2 ⫾ 36.9 (P ⫽ 0.060)* 133.1 ⫾ 36.2 125.8 ⫾ 41.3 ⫺7.3 ⫾ 30.8 (P ⫽ 0.041)* 0.865 5.7 ⫾ 0.6 5.8 ⫾ 0.5 0.1 ⫾ 0.4 (P ⫽ 0.165)* 5.7 ⫾ 0.5 5.7 ⫾ 0.4 0.0 ⫾ 0.3 (P ⫽ 0.203)* 0.060 96.9 ⫾ 76.3 114.0 ⫾ 72.6 17.9 ⫾ 63.8 (P ⫽ 0.035)* 104.2 ⫾ 80.24 150.8 ⫾ 75.18 46.6 ⫾ 95.5 (P ⬍ 0.001)* 0.034 209.9 ⫾ 36.6 207.9 ⫾ 36.8 ⫺2.0 ⫾ 35.1 (P ⫽ 0.607)* 212.2 ⫾ 43.8 201.9 ⫾ 35.6 ⫺10.3 ⫾ 35.9 (P ⫽ 0.011)* 0.144 53.5 ⫾ 13.2 51.3 ⫾ 14.5 ⫺2.2 ⫾ 9.4 (P ⫽ 0.044)* 55.9 ⫾ 14.1 54.6 ⫾ 14.9 ⫺1.3 ⫾ 6.9 (P ⫽ 0.104)* 0.479 144.1 ⫾ 102.1 141.6 ⫾ 99.5 ⫺2.5 ⫾ 100.3 (P ⫽ 0.823)* 156.2 ⫾ 151.0 120.6 ⫾ 65.5 ⫺35.6 ⫾ 136.8 (P ⫽ 0.022)* 0.087 139.1 ⫾ 15.9 138.1 ⫾ 15.3 ⫺1.0 ⫾ 16.7 (P ⫽ 0.610)* 141.8 ⫾ 18.6 137.2 ⫾ 17.1 ⫺4.6 ⫾ 19.1 (P ⫽ 0.035)* 0.217 87.3 ⫾ 9.7 85.2 ⫾ 12.3 ⫺2.1 ⫾ 12.6 (P ⫽ 0.151)* 88.5 ⫾ 10.5 84.1 ⫾ 10.4 ⫺4.4 ⫾ 11.7 (P ⫽ 0.001)* 0.255 10.2 ⫾ 4.3 11.7 ⫾ 4.7 1.5 ⫾ 3.0 (P ⬍ 0.001)* 10.0 ⫾ 4.0 13.9 ⫾ 4.2 3.9 ⫾ 3.8 (P ⬍ 0.001)* 0.0011 6.3 ⫾ 3.9 5.8 ⫾ 3.9 ⫺0.4 ⫾ 2.6 (P ⫽ 0.247)* 6.1 ⫾ 3.2 4.9 ⫾ 2.6 ⫺1.2 ⫾ 2.7 (P ⬍ 0.001)* 0.049 Control BMI (kg/m²) Baseline Endpoint Change from baseline to endpoint Weight (kg) Baseline Endpoint Change from baseline to endpoint Waist circumference (cm) Baseline Endpoint Change from baseline to endpoint Fasting glucose (mg/dl) Baseline Endpoint Change from baseline to endpoint 2-h postprandial OGTT (mg/dl) Baseline Endpoint Change from baseline to endpoint A1C (%) Baseline Endpoint Change from baseline to endpoint Physical exercise (min/week) Baseline Endpoint Change from baseline to endpoint Total cholesterol (mg/dl) Baseline Endpoint Change from baseline to endpoint HDL cholesterol (mg/dl) Baseline Endpoint Change from baseline to endpoint Triglycerides (mg/dl) Baseline Endpoint Change from baseline to endpoint Systolic blood pressure (mmHg) Baseline Endpoint Change from baseline to endpoint Diastolic blood pressure (mmHg) Baseline Endpoint Change from baseline to endpoint TFEQ Cognitive restraint Baseline Endpoint Change from baseline to endpoint Disinhibition Baseline Endpoint Change from baseline to endpoint Continued on following page 1144 DIABETES CARE, VOLUME 32, NUMBER 7, JULY 2009 Kulzer and Associates Table 1—Continued Hunger Baseline Endpoint Change from baseline to endpoint Psychological well-being by WHO-5 Baseline Endpoint Change from baseline to endpoint Depression by CES-D Baseline Endpoint Change from baseline to endpoint Trait Anxiety by STAI Baseline Endpoint Change from baseline to endpoint Control PREDIAS Between-group P-value 4.9 ⫾ 3.8 4.7 ⫾ 3.8 ⫺0.2 ⫾ 2.7 (P ⫽ 0.434)* 4.5 ⫾ 3.4 3.4 ⫾ 3.1 ⫺1.1 ⫾ 3.1 (P ⫽ 0.002)* 0.066 14.3 ⫾ 4.9 14.3 ⫾ 5.1 0.0 ⫾ 4.2 (P ⫽ 0.901)* 15.3 ⫾ 5.1 16.7 ⫾ 4.8 1.4 ⫾ 3.9 (P ⫽ 0.015)* 0.101 13.7 ⫾ 8.2 11.4 ⫾ 7.8 ⫺2.3 ⫾ 6.8 (P ⫽ 0.009)* 12.0 ⫾ 9.5 9.8 ⫾ 7.5 ⫺2.2 ⫾ 7.7 (P ⫽ 0.031)* 0.876 39.5 ⫾ 9.8 38.5 ⫾ 9.5 ⫺1.0 ⫾ 6.1 (P ⫽ 0.142)* 38.5 ⫾ 10.4 34.5 ⫾ 9.5 ⫺3.5 ⫾ 7.1 (P ⫽ 0.001)* 0.023 Data are means ⫾ SD. *P ⫽ within group test. OGGT, oral glucose tolerance test; STAI, State-Trait Anxiety Inventory; TFEQ, Three Factor Eating Questionnaire. ses were performed by paired t tests for within-group differences and independent t tests for between-group differences. Program The prevention program consisted of 12 lessons lasting ⬃90 min each. During the first 8 weeks, eight core lessons were given with one per week; the last four lessons were bimonthly booster lessons. The PREDIAS program, which is based on self-management theory, was conducted in small groups (median size seven people). PREDIAS was delivered by either diabetes educators or psychologists. The program comprised a set of transparencies for the lessons and a curriculum for the prevention manager. Each participant received an exercise book, which contained information about diabetes prevention. This book also contained resources for the participants such as a table of caloric values and worksheets (e.g., eating diaries and logbooks for physical activity) for each lesson. More details about PREDIAS can be accessed at the homepage of the European Union Project: Development and Implementation of a European Guideline and Training Standards for Diabetes Prevention (IMAGE) at http://www.image-project. eu/pdf/praedias (14). RESULTS — A total of 182 participants were randomized (aged 56.3 ⫾ 10.1 years, 43% female, education 13.2 ⫾ 4.1 years, BMI 31.5 ⫾ 5.3 kg/m2, fasting DIABETES CARE, VOLUME 32, NUMBER 7, JULY 2009 glucose 105.7 ⫾ 12.8 mg/dl, and 2-h postprandial postoral glucose 135.7 ⫾ 35.8 mg/dl). There were no significant baseline differences between those in the PREDIAS and the control group. The study lost 17 participants (9.3%) to follow-up. A dropout analysis showed no significant differences between participants who remained in the study and those who dropped out. After 12 months, there was a significant effect on body weight (Table 1). Participants in the PREDIAS group had lost 3.8 kg of weight, whereas members of the control group had reduced their weight by 1.4 kg (P ⫽ 0.001). An intention-totreat analysis yielded similar results (control group ⫺1.3 ⫾ 3.9 kg vs. PREDIAS group ⫺3.6 ⫾ 5.1 kg; P ⬍ 0.001). A significantly higher proportion of weight was lost by those in the PREDIAS than in the control group (4 ⫾ 5.4 vs. 1.6 ⫾ 4.1%, respectively; P ⫽ 0.002). Similar results were obtained regarding BMI and waist circumference. Both groups increased their physical activity significantly, but the increase was significantly greater in the PREDIAS than in the control group. Cognitive restraint of eating behavior was significantly more increased in the PREDIAS than in the control group, and eating disinhibition was significantly more decreased in the PREDIAS than in the control group. Members of the PREDIAS group showed a significant within-group reduction on the hunger scale, but there was no significant betweengroup difference. There was a significant effect of PREDIAS on fasting glucose; however, the 2-h postprandial glucose values and A1C did not change significantly between the groups. Total cholesterol and triglycerides, as well as systolic and diastolic blood pressure, were significantly reduced in the PREDIAS group, whereas in the control group there was no substantial change in these risk factors. However, the between-group difference failed to reach significance. In both groups, psychological wellbeing increased, whereas anxiety and depressive symptoms decreased. However, except for anxiety, there were no significant differences between the two groups. CONCLUSIONS — The PREDIAS prevention program was able to reduce weight and modify eating behavior and physical activity significantly; thus, diabetes risk was reduced. The magnitude of these effects and the observed metabolic changes were in the range of previously published results of diabetes prevention programs (3–5,15). Acknowledgments — The conduct of this study was supported by an unrestricted grant from Roche Diagnostics, Germany. No other potential conflicts of interest relevant to this article were reported. Parts of this study were presented in abstract form at the 69th Scientific Sessions of 1145 Efficacy of a diabetes prevention group program the American Diabetes Association, New Orleans, Louisiana, 5-9 June 2009. We thank Siemens AG, Erlangen, Germany; the cities of Erlangen and Wuerzburg; the Association of Primary Care Physicians, Wuerzburg, Germany; and the Main Tauber Country, Germany, for their collaboration. References 1. Zimmet P, Alberti KG, Shaw J. Global and societal implications of the diabetes epidemic. Nature 2001;414:782–787 2. Schwarz PE, Schwarz J, Schuppenies A, Bornstein SR, Schulze J. Development of a diabetes prevention management program for clinical practice. Public Health Rep 2007;122:258 –263 3. Gillies CL, Abrams KR, Lambert PC, Cooper NJ, Sutton AJ, Hsu RT, Khunti K. Pharmacological and lifestyle interventions to prevent or delay type 2 diabetes in people with impaired glucose tolerance: systematic review and meta-analysis. BMJ 2007;334:299 4. Orozco LJ, Buchleitner AM, GimenezPerez G, Roque IF, Richter B, Mauricio D. Exercise or exercise and diet for preventing type 2 diabetes mellitus. Cochrane 1146 Database Syst Rev 2008;3:CD003054 5. Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002;346:393– 403 6. Diabetes Prevention Program Research Group: The Diabetes Prevention Program (DPP). Description of lifestyle intervention. Diabetes Care 2002;25:2165–2171 7. Lindström J, Tuomilehto J. The diabetes risk score: a practical tool to predict type 2 diabetes risk. Diabetes Care 2003;26:725–731 8. Mensink GBM. Körperliche Aktivität [Physical activity]. Gesundheitswesen 61 Sonderheft 1999;2:S216 –S131 [in German] 9. Pudel V, Westenhöfer J. Fragebogen zum Ernährungsverhalten (FEV) [Questionnaire about eating behavior]. Göttingen, Germany, Hogrefe, 1989 [in German] 10. Stunkard AJ, Messick S. The three factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res 1985;29:71– 83 11. Laux L, Glanzmann P, Schaffner P, Spielberger D. Das State-Trait-Angstinventar. Theoretische Grundlagen und Handanweis- 12. 13. 14. 15. ung [The State Trait Anxiety Inventory. Theoretical principles and manual]. Weinheim, Germany, Beltz, 1981 [in German] Psychiatric Research Unit and WHO Collaborating Center for Mental Health. WHO-Five Well-Being Index (WHO-5) [Internet], 1998. Available from http:// www.who-5.org/. Accessed 15 January 2009 Hautzinger M, Bailer J. Allgemeine Depressions-Skala [General Depression Scale]. Göttingen, Germany, Hogrefe, 1993 [in German] IMAGE Project Management. IMAGE (Development and Implementation of a European Guideline and Training Standards for Diabetes Prevention) [Internet], 2009. Available from http://www.imageproject.eu/pdf/praedias. Accessed 11 April 2009 Tuomilehto J, Lindström J, Eriksson JG, Valle TT, Hämäläinen H, Ilanne-Parikka P, Keinänen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med 2001;344:1343–1350 DIABETES CARE, VOLUME 32, NUMBER 7, JULY 2009