search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Impact of communicating familial risk of diabetes using a web-based tailored advice on preventive behaviour.


- candidate number6287
- NTR NumberNTR1938
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-aug-2009
- Secondary IDsWC2008-011 Scientific Committee of the EMGO Institute for Health and Care Research.
- Public TitleImpact of communicating familial risk of diabetes using a web-based tailored advice on preventive behaviour.
- Scientific TitleImpact of communicating familial risk of diabetes using a web-based tailored advice on preventive behaviour.
- ACRONYMPreDiCT
- hypothesisThe 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) studiedDiabetes Mellitus Type 2 (DM type II), Prevention, Family history, Internet based tailored advice, Randomized controlled trial
- Inclusion criteriaHealthy 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 criteriaExclusion 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 19-mei-2009
- planned closingdate19-sep-2009
- Target number of participants1110
- InterventionsThe (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 outcome1. 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 outcome1. 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.
- TimepointsBaseline, 1week and 3 months.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMSc Miranda Pijl
- CONTACT for SCIENTIFIC QUERIESdr. L. Henneman
- Sponsor/Initiator VU University Medical Center, EMGO+ Institute
- Funding
(Source(s) of Monetary or Material Support)
Centre for Society and Genomics (CSG), Netherlands Genomics Initiative (NGI)
- PublicationsN/A
- Brief summaryFamily 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)
- RECORD7-aug-2009 - 11-okt-2009


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl