|- candidate number||7887|
|- NTR Number||NTR2264|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-mrt-2010|
|- Secondary IDs||MEC-2009-143 Erasmus Medical Ethical Comittee|
|- Public Title||Prevention Of WEight Regain in diabetes type 2 (POWER).|
|- Scientific Title||Prevention Of WEight Regain in diabetes type 2 (POWER). The effectiveness of adding a Combined Psychological Intervention to a very low calorie diet: A randomized controlled trial.|
|- hypothesis||Adding a Combined Psychological Intervention to a very low calorie diet is more effective then a very low calorie diet followed by usual care in maintaining weight loss and improving glycaemic control, cardiovascular risk score, psychological variables and quality of life in patients with diabetes type 2.|
|- Healt Condition(s) or Problem(s) studied||Overweight, Diabetes Mellitus Type 2 (DM type II), Obesity|
|- Inclusion criteria||1. Diagnosed diabetes mellitus type 2;|
2. Age 18-70 years;
3. BMI 27 kg/m2 or more.
|- Exclusion criteria||1. Pregnancy or lactation during the study;|
2. Inadequate expression of the Dutch language (spoken and written);
3. Inability to lose 5% or more of the bodyweight during the first 8 weeks of VLCD;
4. Severe psychiatric problems;
5. Significant cardiac arrhythmias, unstable angina, decompensated congestive heart failure, major organ system failure, untreated hypothyroidism and/or myocardial infarction, end-stage renal disease, cerebrovascular accident or major surgery in the last 3 months;
6. Absence on > 8 sessions CPI.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||24-mrt-2010|
|- planned closingdate||1-jan-2014|
|- Target number of participants||250|
|- Interventions||1. Very low calorie diet + usual care;|
2. very low calorie diet + usual care + Combined Psychological Intervention (CPI).
The first 8 weeks, a very low calorie diet will be given, consisting of 750 calories a day. After these 8 weeks, the diet will become less low, building up to 1300 calories a day in 2x 8 weeks.
After the first 8 weeks, randomisation will take place. Only participants who lost more than 5% of their body weight will be randomised.
CPI: An integrated multimodel group treatment, consists of cognitive restructuring, Problem Solving Therapy and Proactive Coping. During the first 10 weeks there will be a weekly session of 1,5 hours. After those 10 weeks, the session will become less frequent. A total of 17 sessions is planned.
|- Primary outcome||The primary endpoint with respect to the efficacy of CPI, is the between-group difference in weight change (kg) measured as weight after 2 years follow-up minus weight at week 12 (directly after intervention). |
|- Secondary outcome||1. Anthropometric measurements: BMI, waist-hip-ratio, bellycircumference, body composition (%fat and lean body mass);|
2. Cardiovascular riskprofile: HbA1c, HOMA241, bloodpressure, lipids profile;
3. Glycaemic control: insulin, glucose;
4. Psychological measurements: EuroQol, HADS, VOEG-13, CIS, RSE;
5. Lifestyle: SQUASH, EDE-Q;
6. Cost effectiveness: SRS, TIC-P.
|- Timepoints||Outcome measurments at baseline, week 23 (after intervention), 1 year, 1,5 years and 2 years.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| Kirsten Berk|
|- CONTACT for SCIENTIFIC QUERIES|| Kirsten Berk|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center|
|- Brief summary||In this randomized controlled trial we investigate the effectiviness of adding a Combined Psychological Intervention to a very low calorie diet, as compared to usual care, in maintaining weight loss and improving glycaemic, cardiovascular and psychological parameters in patients with type 2 diabetes and overweight.|
|- Main changes (audit trail)|
|- RECORD||30-mrt-2010 - 14-jul-2017|