In this RCT we combine cognitive behavioural therapy (CBT) with a maintenance contract and a specific diet (very low calorie diet), to obtain and maintain favourable effects on weight and risk profile over the long term.
ID
Source
Brief title
Condition
- Diabetic complications
- Diabetic complications
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures are weight (kg) and weight regain.
Secondary outcome
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.
Background summary
Obesity is thought to be of major pathogenetic importance in type 2 diabetic
patients and can contribute to poor glycemic control and increase the risk for
cardiovascular disease. It is estimated that over 80% of patients with diabetes
type 2 is overweight (BMI>25 kg/m2). To achieve a more favourable risk profile,
changes in diet and lifestyle are needed. However, current treatment programs
for obese DM type 2 patients are not effective over the long term.
Study objective
In this RCT we combine cognitive behavioural therapy (CBT) with a maintenance
contract and a specific diet (very low calorie diet), to obtain and maintain
favourable effects on weight and risk profile over the long term.
Study design
This study is a randomised parallel group intervention study, with varying
block size.
Intervention
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 finishing the 3-months diet period, the control
group will receive the normal treatment. During the very low calorie diet, the
intervention group starts with cognitive behavioural group therapy for 10
weeks. Subsequently, the intervention group will receive 7 evaluation group
meetings till the end of de study (2 years).
Study burden and risks
There are minimal risks associated with participation in this study. However,
the metabolic benefits outweigh the investment of time and possible adverse
effects.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
Diabetes mellitus type 2
Overweight: Body Mass Index (BMI) > 25 kg/m2
Age >18 years
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26508.078.09 |
| Other | NTC2264 |