|- candidate number||2226|
|- NTR Number||NTR761|
|- Date ISRCTN created||22-nov-2006|
|- date ISRCTN requested||8-nov-2006|
|- Date Registered NTR||1-sep-2006|
|- Secondary IDs||N/A |
|- Public Title||Using family history as a tool to increase risk awareness and to motivate preventive behaviour of individuals at risk for diabetes type 2.|
|- Scientific Title||Using family history as a tool to increase risk awareness and to motivate preventive behaviour of individuals at risk for diabetes type 2.|
|- ACRONYM||Using family history as a tool to motivate preventive behaviour|
|- hypothesis||As a result of the intervention we hypothesize that:
Due to a tailored consultation provided by a counsellor, containing information on the causes and consequences of DM2 (with emphasis on familial risk) (intervention group compared to control group):
1. perceived risk will increase due to an improved perception of the nature and height of the risk.
2. people’s perceptions of the causes and consequences of DM2 will be more accurate.
3. perceived severity of DM2 will increase due to more insight into the consequences of DM2.
4. a higher protection motivation is expected.
Due to risk reduction information (information on preventive options) (both groups):
5. perceived controllability (or response efficacy) will increase because of increased understanding that the risk can be reduced due to behaviour change.
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus type 2 (DM type II)|
|- Inclusion criteria||1. Positive family history;|
2. Symptom Risk Questionnaire Scores > 10 (highest expected effects from the intervention);
3. Aged < 75 years (born > 01.01.1931).
|- Exclusion criteria||1. People with diagnosed DM2. |
2. People unable to complete questionnaires in Dutch.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2006|
|- planned closingdate||1-jun-2007|
|- 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) & intensive risk reduction information (intervention group);
2. general risk information3 & intensive risk reduction information (control group).
|- Primary outcome||Main outcome is protection motivation:|
Intention to engage in DM2 risk-reducing behaviour. Three core behavioural intentions will be assessed:
increasing physical activity, restricting calories by eating low fat foods, and 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||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).
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||dr. L. Henneman|
|- CONTACT for SCIENTIFIC QUERIES||dr. L. Henneman|
|- Sponsor/Initiator ||VU University Medical Center, Department of Public and Occupational Health|
(Source(s) of Monetary or Material Support)
|Maatschappelijke Aspecten van Genomics van het Centre for Medical Systems Biology (MAGCMSB)|
|- Brief summary||Diabetes mellitus type 2 (DM2) is a serious health problem and prevention is especially important for people with positive family history, since this is seen as one of the strongest risk factors. Little is known how people will respond to personalised risks for diseases that are partly determined by genes, especially with regard to complex diseases such as diabetes. In addition, we do not know what kind of information is needed to increase people’s protection motivation. We developed a tailored risk communication tool for DM2 prevention based on people’s family history (family history tool). In this study, two models are used as theoretical framework: Self-Regulatory Model and the Protection Motivation Theory. |
High DM2 risk individuals (positive family history and other risk factors, e.g. overweight) are recruited. The intervention consists of an educational session based on a counselling model in which information on the causes and consequences of DM2 (with emphasis on familial risk based on the pedigree) (A) is presented by a trained counsellor. In the control group, general risk information is provided. In addition, both groups will receive risk reduction information (information on preventive options) (B), with a known medium effect on intention to change behaviour. The underlying goal of the intervention is to change people's perceptions of risk, perceived causes and consequences of diabetes and thereby to give a higher increase in people’s intention to change behaviour compared to a control group.
Therefore, subjects are randomly allocated to one of two groups based on the information they will receive:
1. risk information based on family history including information on the causes and consequences of DM2 & intensive risk reduction information (intervention group);
2. general risk information & intensive risk reduction information (control group)
Each group has n=45 persons. In both groups, before the consultation, diabetes risk profile is assessed using a validated risk test using self-reported questions, including risk factors that are not modifiable (e.g. family history, age) as well as behavioural and lifestyle factors that can be changed to reduce risk (e.g. weight, physical activity, diet). Changes in perceived risk, causes and consequences of DM2, perceived controllability and protection motivation (intention to change health behaviour) are assessed using questionnaires. Respondents in the intervention group are expected to have a better perception of the nature and height of the DM2 risk (increased vulnerability). Additional information on how to reduce the risk is expected to lead to an increased controllability of the risk, a better understanding of preventive measures and an increased intention to change behaviour (protection motivation). If it can be shown that knowledge regarding risks associated with family history in addition to risk reduction information can motivate preventive behaviour, then this could be used as a tool in DM2 prevention, and ultimately healthier people.
|- Main changes (audit trail)|
|- RECORD||1-sep-2006 - 1-dec-2009|