The objective of the study is to assess the effects and cost-effectiveness of a cognitive behavior intervention in people at risk for CVD or DM2.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Glucose metabolism disorders (incl diabetes mellitus)
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Effects in terms of changes in cardiovascular risk profile and changes in risk
of developing diabetes
Secondary outcome
- Changes in dietary, physical activity, and smoking behavior.
- Economic evaluation from the societal perspective and from the perspective of
the health insurer
Background summary
Title of the study
Primary prevention of diabetes mellitus type 2 and cardiovascular diseases
using a cognitive behavior program aimed at lifestyle changes in people with
abdominal obesity
Partly because of the ageing population, and partly due to changes in lifestyle
and the resulting epidemic of obesity, the percentage of people with
cardiovascular diseases (CVD) and diabetes mellitus type 2 (DM2) is growing
rapidly. CVD and DM2 are to a large extent caused by lifestyle dependent risk
factors, such as overweight, reduced physical activity, and an unhealthy diet.
Changing these risk factors has the potential to postpone or prevent the
development of CVD or DM2.
Study objective
The objective of the study is to assess the effects and cost-effectiveness of a
cognitive behavior intervention in people at risk for CVD or DM2.
Study design
A multicenter randomized controlled trial
Intervention
The intervention group will receive a cognitive behavior program (CBP) given by
specially trained nurse practitioners at general practices. The CBP consists of
up to six individual sessions of 30 minutes and aims to increase the
participants' motivation and ability to change their lifestyle. The CBP will be
followed by 3-monthly booster sessions by phone or e-mail. The participants in
the control group will receive written information about their risk of CVD
and/or DM2, and existing brochures on health guidelines regarding physical
activity and diet, and on smoking cessation. The intervention will be
coordinated throughout the Diabetic Research Center Hoorn, in which the
measurements also will take place. After baseline there will be three follow
up measurements (after 6, 12 and 24 months). An economic evaluation will take
place after 24 months
Study burden and risks
Participation involves time investment (altogether about 5 hours for
participants in the intervention group and 2 hours for the control group).
There are no risks associated with trial participation.
van der Boechorststraat 7
1081 BT Amsterdam
NL
van der Boechorststraat 7
1081 BT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
age 30-50 years, living in West-Friesland, at moderate or high risk of cardiovascular diseases and/of high risk of developing diabetes mellitus, able to perform physical exercise.
Exclusion criteria
diabetes or cardiovascular diseases (in the past or during recruition), pregnancy, mobility 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 |
|---|---|
| ISRCTN | ISRCTN59358434 |
| CCMO | NL16579.029.07 |