Motivational and behavioral effects of adding genetic test feedback to advice on weight gain prevention
| ISRCTN | ISRCTN91178663 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91178663 |
| Secondary identifying numbers | N/A |
- Submission date
- 21/02/2012
- Registration date
- 03/05/2012
- Last edited
- 01/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Research has shown that genes play a big part in how easily people gain weight. People can find out if they have genes which put them at higher risk for gaining weight by using genetic tests. These tests are available over the internet. However, it is currently not known whether receiving personal results from these tests is useful.
The aim of this study is to find out whether giving people their personal genetic result for risk of weight gain motivates them to try and keep a healthy weight. We will investigate this in young adults at the beginning of university, because weight gain is common in students.
Who can participate?
First year university students, aged between 18 and 25 years, enrolled at University College London, who agree to take part in a larger study will be invited to participate.
What does the study involve?
They will be randomly (i.e. by chance) split into two groups:
One group will receive their personal genetic test result for one gene (FTO) related to risk of weight gain alongside a leaflet with simple weight gain prevention advice.
The other group will receive only the leaflet containing simple weight gain prevention advice. Participants receiving only the leaflet will receive their genetic test result at the end of the study. The study will run over the course of the academic year. We will look at whether people who receive their test result and the leaflet are more motivated to prevent weight gain than people who just receive the leaflet.
What are the possible benefits and risks of participating?
Benefits of taking part include learning about personal genetic risk of weight gain (based on one gene), and receiving advice on how to keep a healthy weight.
There is little risk involved in participation, and we will be available to answer any questions or concerns. We will also conduct interviews to find out more about participants thoughts and feelings after receiving their genetic test result.
Where is the study run from?
The study will take place at University College London.
When is study starting and how long is it expected to run for?
The study started in September 2010 and will run till September 2013.
Who is funding the study?
Cancer Research UK
Who is the main contact?
Prof Jane Wardle
j.wardle@ucl.ac.uk
Contact information
Scientific
Health Behaviour Research Centre
Department of Epidemiology and Public Health
University College London
1-19 Torrington Place
London
WC1E 6BT
United Kingdom
Study information
| Study design | Open two-arm individually randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Adding genetic test feedback to advice on weight gain prevention for young adults : a randomized controlled trial |
| Study objectives | Participants receiving personal genetic test feedback for risk of weight gain in addition to generic weight gain prevention advice will be more motivated to prevent unhealthy weight gain than those receiving generic weight gain prevention advice alone. |
| Ethics approval(s) | University College London Ethics Committee, Sept 2010, ref: 2471/003 |
| Health condition(s) or problem(s) studied | Prevention of weight gain |
| Intervention | Feedback group: Providing personal genetic risk status of the fat mass and obesity (FTO) associated gene implicated in weight gain + a leaflet containing generic weight loss prevention advice. No Feedback group: Only leaflet with generic weight gain prevention advice (feedback returned at end of year). High risk of contamination between groups prevented us to include a 'Control' group which receives neither genetic feedback nor leaflet. |
| Intervention type | Other |
| Primary outcome measure | Self-reported motivation to prevent weight gain immediately after receiving genetic test feedback, assessed with several statements relating to weight gain prevention (Likert scale) |
| Secondary outcome measures | 1. Self-reported motivation at follow-up 2. Self-reported efforts to prevent weight gain at follow-up 3. Body fat and weight change from baseline to follow-up, assessed by weighing and bioelectrical impedance 4. Interactions between feedback condition and gene test status |
| Overall study start date | 26/09/2010 |
| Completion date | 26/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 800 |
| Key inclusion criteria | All interested first year students between ages 18 and 25 from University College London, who are able to give consent |
| Key exclusion criteria | 1. Inability to consent 2. Not aged between 18 and 25 |
| Date of first enrolment | 26/09/2010 |
| Date of final enrolment | 26/09/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
WC1E 6BT
United Kingdom
Sponsor information
University/education
Gower Street
London
WC1E 6BT
England
United Kingdom
| Website | http://www.ucl.ac.uk |
|---|---|
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 06/12/2012 | Yes | No | |
| Results article | results | 01/02/2015 | Yes | No |
Editorial Notes
01/10/2018: Publication reference added.
