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Using family history as a tool to increase risk awareness and to motivate preventive behaviour of individuals at risk for diabetes type two
ISRCTN ISRCTN20442834
DOI 10.1186/ISRCTN20442834
ClinicalTrials.gov identifier
EudraCT number
Public title Using family history as a tool to increase risk awareness and to motivate preventive behaviour of individuals at risk for diabetes type two
Scientific title
Acronym N/A
Serial number at source NTR761
Study hypothesis As a result of the intervention we hypothesise that:

1. Due to a tailored consultation provided by a counsellor, containing information on the causes and consequences of Diabetes Mellitus type Two (DM2) (with emphasis on familial risk) (intervention group compared to control group):
1.1. Perceived risk will increase due to an improved perception of the nature and height of the risk
1.2. People’s perceptions of the causes and consequences of DM2 will be more accurate
1.3. Perceived severity of DM2 will increase due to more insight into the consequences of DM2
1.4. A higher protection motivation is expected
2. Due to risk reduction information (information on preventive options) (both groups) perceived controllability (or response efficacy) will increase because of increased understanding that the risk can be reduced due to behaviour change
Lay summary
Ethics approval Received from local medical ethics committee
Study design Randomised single-blind active-controlled parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Diabetes mellitus type two (DM type II)
Participants - inclusion criteria 1. Positive family history
2. Symptom Risk Questionnaire Scores more than ten (highest expected effects from the intervention)
3. Aged less than 75 years (born after 01/01/1931)
Participants - exclusion criteria 1. People with diagnosed DM2
2. People unable to complete questionnaires in Dutch
Anticipated start date 01/11/2006
Anticipated end date 01/06/2007
Status of trial Completed
Patient information material
Target number of participants 90
Interventions The intervention consists of tailored information (risk communication) on the causes and consequences of DM2 such as cardiovascular disease (with emphasis on familial risk). It will be emphasised that it is even more important to change behaviour, because of a positive family history (which cannot be changed). The consultation is based on a counselling model and is presented by a trained counsellor. Our group has gained extensive experiences in the field of genetic counselling for e.g. familial risk of breast cancer, cystic fibrosis.

The underlying goal of the intervention is to change people's perceptions of risk, and perceived causes and consequences of DM2 to increase their motivation to change behaviour. In addition, all participants receive information on preventive options to help them see how they can cope with their risk (increase controllability).

To analyse the effect of the intervention, subjects are randomly allocated to the intervention or control group:
1. Information on the causes and consequences of DM2 (with emphasis on familial risk) and intensive risk reduction information (intervention group)
2. General risk information and intensive risk reduction information (control group)
Primary outcome measure(s) Protection motivation: Intention to engage in DM2 risk-reducing behaviour. Three core behavioural intentions will be assessed:
1. Increasing physical activity
2. Restricting calories by eating low fat foods
3. Follow subsequent advice to screening for diabetes

Stopping smoking and reducing alcohol intake will also be assessed when relevant. For each participant, intentions towards the three core behaviours will be measured and combined to assess overall motivation to reduce risk.
Secondary outcome measure(s) 1. Illness representations
2. Perceived severity of diabetes
3. Perceived risk of getting diabetes
4. Coping appraisal: self-efficacy
5. Self-reported health behaviour
6. Psychological well-being: Positive And Negative Affect Scale (PANAS).
Sources of funding Societal Aspects of Genomics at the Centre for Medical Systems Biology (Maatschappelijke Aspecten van Genomics van het Centre for Medical Systems Biology [MAGCMSB]) (Netherlands)
Trial website
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19131458
Contact name Dr  L  Henneman
  Address Vu Medical Center
Department of Public Health
P.O. Box 7057
  City/town Amsterdam
  Zip/Postcode 1007 MB
  Country Netherlands
  Tel +31 (0)20 4449815
  Fax +31(0)20 4448387
  Email l.henneman@vumc.nl
Sponsor Vrije University Medical Centre (VUMC) (Netherlands)
  Address Department of Public Health
P.O. Box 7057
  City/town Amsterdam
  Zip/Postcode 1007 MB
  Country Netherlands
Date applied 22/11/2006
Last edited 09/04/2009
Date ISRCTN assigned 22/11/2006
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