Primary prevention of diabetes mellitus type two and cardiovascular diseases using a cognitive behaviour programme aimed at lifestyle changes in people with abdominal obesity
| ISRCTN | ISRCTN59358434 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59358434 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/02/2007
- Registration date
- 26/02/2007
- Last edited
- 13/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J Lakerveld
Scientific
Scientific
VU University Medical Centre
EMGO-Institute
Afd. Huisartsgeneeskunde
Amsterdam
1081 BT
Netherlands
| Phone | +31 20 444 8167 |
|---|---|
| j.lakerveld@vumc.nl |
Study information
| Study design | Randomised, active controlled, parallel group, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Primary prevention of diabetes mellitus type two and cardiovascular diseases using a cognitive behaviour programme aimed at lifestyle changes in people with abdominal obesity |
| Study objectives | It is hypothesised that a cognitive behavioural program that in particular is focused on motivation and self-management in persons at high risk for Cardiovascular Disease (CVD) and/or Diabetes Mellitus type two (DM2) will change their behaviour, which reduces the risk on developing DM2 and the risk on CVD. |
| Ethics approval(s) | VU University Medical Center on 06/2007 (Ref: 2007/107) |
| Health condition(s) or problem(s) studied | Diabetes Mellitus type two (DM2), cognitive behaviour treatment, lifestyle, prevention, cardiovascular disease |
| Intervention | The intervention group will receive a Cognitive Behaviour Program (CBP) consisting of motivational interviewing and problem solving treatment, a program that in particular is focused on motivation and the self-management of the participants. Up to six individual CBP sessions of 30 minutes will be given, followed by three-monthly booster sessions by phone or e-mail. Participants in the control group will receive written information and existing brochures about their risk of CVD and/or DM2. |
| Intervention type | Other |
| Primary outcome measure | 1. Changes in cardiovascular risk score (risk function developed by the SCORE-project) 2. Changes in diabetes risk calculation (risk function from data of the ARIC Study) |
| Secondary outcome measures | 1. Changes in lifestyle factors: 1.1. Dietary behaviour 1.2. Physical activity 1.3. Smoking behaviour 2. Changes in perceived health 3. Changes in medical care utilisation 4. Changes in waist circumference 5. Cost effectiveness and cost-utility (cost diary and Euroqol questionnaire) |
| Overall study start date | 01/08/2007 |
| Completion date | 01/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 600 |
| Key inclusion criteria | 1. Persons aged 30 to 50 years 2. With a moderate or high risk of CVD (as calculated according to the Systematic COronary Risk Evaluation [SCORE]-project) 3. Or a high risk of DM2 (as calculated according to the risk function of the Atherosclerosis Risk In Communities [ARIC] Study) |
| Key exclusion criteria | 1. Having diabetes 2. Previous CVD 3. Pregnancy 4. Current malignant disease 5. (Severe) mobility problems |
| Date of first enrolment | 01/08/2007 |
| Date of final enrolment | 01/08/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Centre
Amsterdam
1081 BT
Netherlands
1081 BT
Netherlands
Sponsor information
VU University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 444 8180 |
|---|---|
| emgo@vumc.nl | |
| Website | http://www.vumc.nl/english/#http://www.vumc.nl/english/ |
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 04/04/2013 | Yes | No | |
| Results article | results | 19/04/2013 | Yes | No |
