Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
20/11/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J Lakerveld

ORCID ID

Contact details

VU University Medical Centre
EMGO-Institute
Afd. Huisartsgeneeskunde
Amsterdam
1081 BT
Netherlands
+31 20 444 8167
j.lakerveld@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

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.

Ethics approval

VU University Medical Center on 06/2007 (Ref: 2007/107)

Study design

Randomised, active controlled, parallel group, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/08/2007

Overall trial end date

01/08/2010

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

600

Participant exclusion criteria

1. Having diabetes
2. Previous CVD
3. Pregnancy
4. Current malignant disease
5. (Severe) mobility problems

Recruitment start date

01/08/2007

Recruitment end date

01/08/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Centre
Amsterdam
1081 BT
Netherlands

Sponsor information

Organisation

VU University Medical Centre (VUMC) (The Netherlands)

Sponsor details

EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8180
emgo@vumc.nl

Sponsor type

Hospital/treatment centre

Website

http://www.vumc.nl/english/#http://www.vumc.nl/english/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23597082

Publication citations

  1. Results

    Lakerveld J, Bot SD, Chinapaw MJ, van Tulder MW, Kostense PJ, Dekker JM, Nijpels G, Motivational interviewing and problem solving treatment to reduce type 2 diabetes and cardiovascular disease risk in real life: a randomized controlled trial., Int J Behav Nutr Phys Act, 2013, 10, 47, doi: 10.1186/1479-5868-10-47.

Additional files

Editorial Notes