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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR893 |
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Date of registration:
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08/02/2007 |
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Primary sponsor: |
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Public title:
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Primary prevention of diabetes mellitus type 2 and cardiovascular diseases using a cognitive behaviour programme aimed at lifestyle changes in people with abdominal obesity.
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Scientific title:
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Primary prevention of diabetes mellitus type 2 and cardiovascular diseases using a cognitive behaviour programme aimed at lifestyle changes in people with abdominal obesity. - N/A |
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Date of first enrolment:
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1/8/2007 |
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Target sample size:
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600 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=893 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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J.
Lakerveld |
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Address:
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VUmc-EMGO
Afd. Huisartsgeneeskunde
, v.d. Boechorststr. 7
1081 BT
Amsterdam
The Netherlands |
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Telephone:
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+31 20 444 8167 |
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Email:
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j.lakerveld@vumc.nl |
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Affiliation:
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Name:
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J.
Lakerveld |
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Address:
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VUmc-EMGO
Afd. Huisartsgeneeskunde
, v.d. Boechorststr. 7
1081 BT
Amsterdam
The Netherlands |
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Telephone:
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+31 20 444 8167 |
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Email:
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j.lakerveld@vumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Persons aged 30-50;
2. With a moderate or high risk of CVD (as calculated according to the SCORE-project);
3. Or a high risk of DM2 (as calculated according to the risk function of the ARIC Study").
Exclusion criteria: 1. Having diabetes
2. Previous CVD;
3. Pregnancy;
4. Current malignant disease;
5. (Severe) Mobility problems.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus type 2 (DM type II), Cognitive behavior therapy, Life style, Prevention, Cardiovascular disease
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Intervention(s)
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The intervention group will receive a cognitive behavior 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 3-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.
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Primary Outcome(s)
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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);
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Secondary Outcome(s)
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1. Changes in lifestyle factors:
a. dietary behaviour;
b. physical activity;
c. smoking behaviour;
2. Changes in perceived health;
3. Changes in medical care utilization;
4. Changes in waist circumference.
5. Cost effectiveness and cost-utility (costdiary and Euroqol).
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Secondary ID(s)
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ISRCTN59358434
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N/A
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Source(s) of Monetary Support
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ZON-MW, The Netherlands Organization for Health Research and Development
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