Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/11/2006
Date assigned
22/11/2006
Last edited
09/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr L Henneman

ORCID ID

Contact details

Vu Medical Center
Department of Public Health
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 4449815
l.henneman@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR761

Study information

Scientific title

Acronym

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

Ethics approval

Received from local medical ethics committee

Study design

Randomised single-blind active-controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/11/2006

Overall trial end date

01/06/2007

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

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

Trial participating centre

Vu Medical Center
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

Vrije University Medical Centre (VUMC) (Netherlands)

Sponsor details

Department of Public Health
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

Societal Aspects of Genomics at the Centre for Medical Systems Biology (Maatschappelijke Aspecten van Genomics van het Centre for Medical Systems Biology [MAGCMSB]) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19131458

Publication citations

  1. Results

    Pijl M, Timmermans DR, Claassen L, Janssens AC, Nijpels G, Dekker JM, Marteau TM, Henneman L, Impact of communicating familial risk of diabetes on illness perceptions and self-reported behavioral outcomes: a randomized controlled trial., Diabetes Care, 2009, 32, 4, 597-599, doi: 10.2337/dc08-1049.

Additional files

Editorial Notes