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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 10.1186/ISRCTN59358434
ClinicalTrials.gov identifier
EudraCT number
Public 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
Scientific title
Acronym N/A
Serial number at source N/A
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval VU University Medical Center on 06/2007 (Ref: 2007/107)
Study design Randomised, active controlled, parallel group, multicentre trial
Countries of recruitment Netherlands
Disease/condition/study domain Diabetes Mellitus type two (DM2), cognitive behaviour treatment, lifestyle, prevention, cardiovascular disease
Participants - 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)
Participants - exclusion criteria 1. Having diabetes
2. Previous CVD
3. Pregnancy
4. Current malignant disease
5. (Severe) mobility problems
Anticipated start date 01/08/2007
Anticipated end date 01/08/2010
Status of trial Completed
Patient information material
Target number of participants 600
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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)
Sources of funding The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23597082
Contact name Dr  J  Lakerveld
  Address VU University Medical Centre
EMGO-Institute
Afd. Huisartsgeneeskunde
  City/town Amsterdam
  Zip/Postcode 1081 BT
  Country Netherlands
  Tel +31 20 444 8167
  Email j.lakerveld@vumc.nl
Sponsor VU University Medical Centre (VUMC) (The Netherlands)
  Address EMGO-Institute
Van der Boechorststraat 7
  City/town Amsterdam
  Zip/Postcode 1081 BT
  Country Netherlands
  Tel +31 (0)20 444 8180
  Fax +31 (0)20 444 8181
  Email emgo@vumc.nl
  Sponsor website: http://www.vumc.nl/english/#http://www.vumc.nl/english/
Date applied 26/02/2007
Last edited 20/11/2013
Date ISRCTN assigned 26/02/2007
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