BeWEL: the impact of a bodyweight and physical activity intervention on adults at risk of developing colorectal adenomas
| ISRCTN | ISRCTN53033856 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53033856 |
| Secondary identifying numbers | 2009ON07; G0802030 |
- Submission date
- 20/09/2010
- Registration date
- 07/02/2011
- Last edited
- 25/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof Annie Anderson
Scientific
Scientific
Centre for Public Health Nutrition Research
University of Dundee
Division of Cinical and Population Sciences and Education
Mailbox 7, Level 7
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
Study information
| Study design | Two-arm multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | BeWEL: a two-arm multicentre randomised controlled trial of a multiple contact personalised intervention programme versus usual care on weight loss |
| Study acronym | BeWEL |
| Study objectives | To evaluate the impact of a an intervention programme ("BeWEL") on body weight change, cardiovascular risk factors, diet and physical activity in healthy individuals attending routine NHS clinics who have had pre-cancerous bowel polyps removed but are at risk of developing future cancer and other obesity related conditions. |
| Ethics approval(s) | Tayside Committee on Medical Research Ethics B Research Ethics Committee, 23/07/2010, ref: 10/S1402/34 |
| Health condition(s) or problem(s) studied | Colorectal cancer and cardiovascular disease |
| Intervention | Intervention group (IG): Receives the "BeWEL" personalised intervention programme, personal body weight scales and invitations to undertake supervised monthly body weight recordings. The BeWEL personalised, multiple contact, intervention programme will include: 1. Goal-setting for weight, activity, and calorie intake 2. Self-monitoring to achieve these goals 3. Frequent contact to provide accountability and sustain focus 4. Use of problem-solving and other "toolbox" strategies to address goals and potential barriers to achieving them 5. Emphasis on managing individual high-risk situations The approach will take particular care to emphasise the importance of regular self weighing which is widely associated with greater weight loss and weight prevention (showing a 1 to 3 BMI unit advantage over individuals who do not self weight frequently). Comparison group (UC): The usual care (UC) group will be given a general leaflet on healthy lifestyle which is widely available in the NHS setting. This will ensure that all participants receive some lifestyle advice which at the moment is given out on an ad hoc basis. The total duration of treatment and follow-up is 12 months. Participants will be followed up at 3 months and 12 months post-baseline, and will receive the BeWEL intervention (or usual care) throughout the whole 12 months. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measures as of 24/05/2011: Measured at baseline, 3 months and 12 months: Body weight (BMI) Previous primary outcome measures: Measured at baseline, 3 months and 12 months: 1. Body weight (BMI) 2. Waist circumference |
| Secondary outcome measures | Measured at baseline, 3 months and 12 months: 1. Waist circumference (Added 24/05/2011) 2. Lipid profile 3. Homeostatic model assessment (HOMA) from fasting insulin and glucose 4. HbA1C 5. Blood pressure 6. Diet 7. Self-assessed health and self-efficacy 8. Objectively measured physical activity levels (from 7 day SenseWear physical activity monitor) 9. Change in primary outcome measures by deprivation 10. Perceived acceptability of the programme (from post-study questionnaires and interviews) 11. Intervention costs |
| Overall study start date | 21/09/2010 |
| Completion date | 20/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 316 participants (158 in each arm) |
| Total final enrolment | 329 |
| Key inclusion criteria | 1. Aged 50 to 74 years, either sex 2. Have participated in the NHS Scottish Bowel Screening Programme 3. Had one or more benign adenomas removed 4. Body mass index (BMI) greater than 25 m/kg2 5. Physically able to undertake exercise requirements 6. Able to provide informed consent |
| Key exclusion criteria | 1. Normal colonoscopy 2. Diagnosed with cancer as a result of their colonoscopy 3. Currently suffering from cancer at another site 4. Rely on insulin administration for glucose control 5. BMI less than 25 kg/m2 |
| Date of first enrolment | 21/09/2010 |
| Date of final enrolment | 20/09/2012 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
University of Dundee
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
Sponsor information
University of Dundee (UK)
University/education
University/education
c/o Dr Anne Langston
Tayside Academic Health Sciences Centre
Ninewells Hospital & Medical School
TAHSC Research & Development Office
Residency Block, Level 3
George Pirie Way
Dundee
DD1 9SY
Scotland
United Kingdom
| Website | http://www.dundee.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/03h2bxq36 |
Funders
Funder type
Research council
Medical Research Council (MRC) - National Prevention Research Initiative (NPRI) (UK) (ref: G0802030)
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 25/03/2011 | Yes | No | |
| Results article | results | 18/12/2013 | Yes | No | |
| Results article | results | 07/03/2014 | Yes | No | |
| Results article | results | 01/03/2015 | Yes | No | |
| Results article | results | 01/06/2018 | 08/11/2019 | Yes | No |
| Plain English results | 25/10/2022 | No | Yes |
Editorial Notes
25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
08/11/2019: Publication reference added.
22/08/2016: Publication reference added.
