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 | https://doi.org/10.1186/ISRCTN20442834 |
| Secondary identifying numbers | NTR761 |
- Submission date
- 22/11/2006
- Registration date
- 22/11/2006
- Last edited
- 09/04/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr L Henneman
Scientific
Scientific
Vu Medical Center
Department of Public Health
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 4449815 |
|---|---|
| l.henneman@vumc.nl |
Study information
| Study design | Randomised single-blind active-controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | |
| 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. Peoples 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 |
| Ethics approval(s) | Received from local medical ethics committee |
| Condition | Diabetes mellitus type two (DM type II) |
| Intervention | 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) |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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). |
| Overall study start date | 01/11/2006 |
| Overall study end date | 01/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 90 |
| Participant 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) |
| Participant exclusion criteria | 1. People with diagnosed DM2 2. People unable to complete questionnaires in Dutch |
| Recruitment start date | 01/11/2006 |
| Recruitment end date | 01/06/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Vu Medical Center
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Sponsor information
Vrije University Medical Centre (VUMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Public Health
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
"ROR" |
https://ror.org/00q6h8f30 |
|---|
Funders
Funder type
Research organisation
Societal Aspects of Genomics at the Centre for Medical Systems Biology (Maatschappelijke Aspecten van Genomics van het Centre for Medical Systems Biology [MAGCMSB]) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2009 | Yes | No |
