|- candidate number||6287|
|- NTR Number||NTR1938|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-aug-2009|
|- Secondary IDs||WC2008-011 Scientific Committee of the EMGO Institute for Health and Care Research.|
|- Public Title||Impact of communicating familial risk of diabetes using a web-based tailored advice on preventive behaviour.|
|- Scientific Title||Impact of communicating familial risk of diabetes using a web-based tailored advice on preventive behaviour.|
|- hypothesis||The main objective of this study is to investigate how the collection of a diabetes family history, interpretation and communication of familial risk information using a web-based tool affects health behaviour, and to explore the possible negative implications for individuals and their families.|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II), Prevention, Family history, Internet based tailored advice, Randomized controlled trial|
|- Inclusion criteria||Healthy people from the general population aged 35-65 years will be recruited. Inclusion criteria:|
1. 35 to 65 years;
2. Body Mass Index (kg/m2) ¡İ 25;
3. People with or without a postive (at least 1 first degree relative) family history of diabetes;
4. Access to a computer and internet.
|- Exclusion criteria||Exclusion criteria (assessed when people are invited for the study):|
1. People with diagnosed diabetes type 1 or 2;
2. People unable to read and complete questionnaires in Dutch;
3. Hindus, Turks, Creoles and Moroccans, since these populations require a specific diabetes risk intervention, due to their higher than avarage risk of getting diabetes.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||19-mei-2009|
|- planned closingdate||19-sep-2009|
|- Target number of participants||1110|
|- Interventions||The (web-based) intervention consists of: |
1. Familial risk assessment, in addition to diabetes risk based on general risk factors, personal risk communication containing familial risk information and lifestyle recommendations (intervention group);
2. Diabetes risk assessment based on general risk factors, personal risk communication and lifestyle recommendations (control group).
|- Primary outcome||1. Mean physical activity level will be measured by the self-administered short version of the International Physical Activity Questionnaire (IPAQ). Time points: Baseline, 3 months;|
2. Mean saturated fat intake using a validated short food frequency questionnaire, the short Fat list. Time points: Baseline, 3 months;
3. Testing for diabetes: the percentage of people who test for diabetes after the risk information and attitudes towards taking a yearly or regular test for diabetes. Time points: Baseline, 3 months.
|- Secondary outcome||1. Body measures: Self-reported waist circumference, BMI (self-reported body weight and length). Time points: Baseline, 3 months;|
2. Threat appraisal: people's perception about the severity of diabetes. Baseline, 1 week and 3 months;
3. Coping appraisal: Self-efficacy, response efficacy for fat intake and physical activity. Time points: Baseline, 1 week and 3 months;
4. Illness representations: Causal beliefs, and perceived personal control adapted from the revised form of the Illness Perception Questionnaire. Time points: Baseline, 1 week and 3 months;
5. Risk perception: perceived susceptibility. Time points: Baseline, 1 week and 3 months;
6. False reassurance: causal beliefs and risk perception will be used to assess false reassurance;
7. Intentions: Intentions to engage in behavioural activities (fat intake, physical activity). Time point: 1 week;
8. Psychological impact: diabetes risk worry. Time points: Baseline, 1 week and 3 months;
9. Perceived implications: perceived impact on autonomy, freedom of choice, responsibility, feelings of stigmatisation and discrimination, worries about confidentiality of the information, impact on family relationships, medicalisation, and practical aspects. Time point: 3 months.
|- Timepoints||Baseline, 1week and 3 months.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MSc Miranda Pijl|
|- CONTACT for SCIENTIFIC QUERIES||dr. L. Henneman|
|- Sponsor/Initiator ||VU University Medical Center, EMGO+ Institute|
(Source(s) of Monetary or Material Support)
|Centre for Society and Genomics (CSG), Netherlands Genomics Initiative (NGI)|
|- Brief summary||Family history is an important and independent risk factor for many common chronic diseases, reflecting the consequences of genetic predisposition, shared environment, and common behaviour. It is seen as a useful tool for disease prevention in public health and preventive medicine, and may be used for tailoring behavioural messages. Internet is seen as an effective way to improve health and disseminate information among the public, even when people do not perceive themselves at risk for disease. In this study type 2 diabetes is taken as an example. The main objective of this study is to investigate how the collection of a diabetes family history, interpretation and communication of familial risk information using a web-based tool affects health behaviour, and to explore the possible negative implications for individuals and their families.|
Research questions are:
1. What is the impact of the collection of a family history of diabetes and communicating familial risk information of diabetes in a web-based tailored intervention on preventive behaviour?
A. What is the effect on health behaviour change (saturated fat intake, physical activity, test for diabetes)?
B. To what extent does the information affect causal beliefs, personal control, and perceived susceptibility?
C. Are people without a positive family history falsely reassured about their risk for diabetes, when the emphasis in the diabetes risk communication is on familial risk?
2. What are possible implications for the individual¡¯s freedom of choice, feelings of stigmatisation and discrimination, worries about confidentiality of the information, and impact on family relationships?
|- Main changes (audit trail)|
|- RECORD||7-aug-2009 - 11-okt-2009|