JOURNAL ARTICLE
PRAGMATIC CLINICAL TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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Group cognitive behavioural therapy and weight regain after diet in type 2 diabetes: results from the randomised controlled POWER trial.

Diabetologia 2018 April
AIMS/HYPOTHESIS: Weight-loss programmes for adults with type 2 diabetes are less effective in the long term owing to regain of weight. Our aim was to determine the 2 year effectiveness of a cognitive behavioural group therapy (group-CBT) programme in weight maintenance after diet-induced weight loss in overweight and obese adults with type 2 diabetes, using a randomised, parallel, non-blinded, pragmatic study design.

METHODS: We included 158 obese adults (median BMI 36.3 [IQR 32.5-40.0] kg/m2 ) with type 2 diabetes from the outpatient diabetes clinic of Erasmus MC, the Netherlands, who achieved ≥5% weight loss on an 8 week very low calorie diet. Participants were randomised (stratified by weight loss) to usual care or usual care plus group-CBT (17 group sessions). The primary outcomes were the between-group differences after 2 years in: (1) body weight; and (2) weight regain. Secondary outcomes were HbA1c levels, insulin dose, plasma lipid levels, depression, anxiety, self-esteem, quality of life, fatigue, physical activity, eating disorders and related cognitions. Data were analysed using linear mixed modelling.

RESULTS: During the initial 8 week dieting phase, the control group (n = 75) lost a mean of 10.0 (95% CI 9.1, 10.9) kg and the intervention group (n = 83) lost 9.2 (95% CI 8.4, 10.0) kg (p = 0.206 for the between-group difference). During 2 years of follow-up, mean weight regain was 4.7 (95% CI 3.0, 6.3) kg for the control group and 4.0 (95% CI 2.3, 5.6) kg for the intervention group, with a between-group difference of -0.7 (95% CI -3.1, 1.6) kg (p = 0.6). The mean difference in body weight at 2 years was -1.2 (95% CI -7.7, 5.3) kg (p = 0.7). None of the secondary outcomes differed between the two groups.

CONCLUSIONS/INTERPRETATION: Despite increased treatment contact, a group-CBT programme for long-term weight maintenance after an initial ≥5% weight loss from dieting in obese individuals with type 2 diabetes was not superior to usual care alone.

TRIAL REGISTRATION: Trialregister.nl NTR2264 FUNDING: The study was funded by the Erasmus MC funding programme 'Zorgonderzoek' (grant 2008-8303).

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