The effectiveness of an intervention, including a very low calorie diet, cognitive behavioural therapy and maintenance contract, regarding weight and weight regain, diabetes management, cardiovasculair risk, depression and quality of life in overweight patients with type 2 diabetes mellitus, after 2 year follow-up.

The effectiveness of an intervention, including a very low calorie diet, cognitive behavioural therapy and maintenance contract, regarding weight and weight regain, diabetes management, cardiovasculair risk, depression and quality of life in overweight patients with type 2 diabetes mellitus, after 2 year follow-up. - Prevention Of WEight Regain in diabetes type 2 (POWER)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39024

Enrollment

300

Registered

2009-06-29

Start date

2009-10-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes Overweight

Interventions

Participants all start with a very low calorie diet and will be included in the study by obtaining 5% weight loss, after which they will be randomly assigned to the 2 research groups. After finishin

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diabetes mellitus type 2 Overweight: Body Mass Index (BMI) > 25 kg/m2 Age >18 years

Exclusion criteria

Exclusion criteria: Pregnancy/lactation Inadequate knowledge of the Dutch language/Inability to fill in questionnaires Inability to lose 5% of body weight during very low calorie diet Severe psychiatric problems

Design outcomes

Primary

Measure	Time frame
Primary outcome measures are weight (kg) and weight regain.	—

Secondary

Measure	Time frame
Other outcome measures are Body Mass Index (BMI = weight (kg) / length (m)2), HbA1c (%), waist circumference (cm), systolic blood pressure (mmHg), lipid levels (LDL, HDL, TG (mmol/l)en chol/HDL), antidiabetic agents en doses, cardiovascular risk (UKPDS), lifestyle and quality of life (EuroQol). A smaal amount of hair will be collected at 3 timepoints during te study to measure haircortisol. Psychosocial parameters like depression, self-esteem, relational functioning and fear for negative appearance evaluation are studied, as secondary outcome as well as determinant for weight loss. In this unique population we want to collect DNA-material to study the genetic factors associated with succeeding of the intervention. Last but not least we want to conduct an analysis of the cost effectiveness of the intervention as compared to usual care.	—

Measure

Time frame

Other outcome measures are Body Mass Index (BMI = weight (kg) / length (m)2), HbA1c (%), waist circumference (cm), systolic blood pressure (mmHg), lipid levels (LDL, HDL, TG (mmol/l)en chol/HDL), antidiabetic agents en doses, cardiovascular risk (UKPDS), lifestyle and quality of life (EuroQol). A smaal amount of hair will be collected at 3 timepoints during te study to measure haircortisol. Psychosocial parameters like depression, self-esteem, relational functioning and fear for negative appearance evaluation are studied, as secondary outcome as well as determinant for weight loss. In this unique population we want to collect DNA-material to study the genetic factors associated with succeeding of the intervention. Last but not least we want to conduct an analysis of the cost effectiveness of the intervention as compared to usual care.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)