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
Protocol serial number	2009ON07; G0802030
Sponsor	University of Dundee (UK)
Funder	Medical Research Council (MRC) - National Prevention Research Initiative (NPRI) (UK) (ref: 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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-to-assess-impact-of-lifestyle-advice-to-people-who-have-had-a-bowel-adenoma-removed-bewel

Contact information

Prof Annie Anderson
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

Primary study design	Interventional
Study design	Two-arm multicentre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	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
Completion date	20/09/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	316
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

United Kingdom
Scotland

Study participating centre

University of Dundee

Dundee
DD1 9SY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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?
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
Protocol article	protocol	25/03/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
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.