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BeWEL: the impact of a bodyweight and physical activity intervention on adults at risk of developing colorectal adenomas
ISRCTN ISRCTN53033856
DOI 10.1186/ISRCTN53033856
ClinicalTrials.gov identifier
EudraCT number
Public title BeWEL: the impact of a bodyweight and physical activity intervention on adults at risk of developing colorectal adenomas
Scientific title BeWEL: A two arm multicentre randomised controlled trial of a multiple contact personalised intervention programme versus usual care on weight loss
Acronym BeWEL
Serial number at source 2009ON07; G0802030
Study hypothesis 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.
Lay summary http://cancerhelp.cancerresearchuk.org/trials/a-study-to-assess-impact-of-lifestyle-advice-to-people-who-have-had-a-bowel-adenoma-removed-bewel
Ethics approval Tayside Committee on Medical Research Ethics B Research Ethics Committee (REC) approved on 23/07/2010 (ref: 10/S1402/34)
Study design Two-arm multicentre randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Colorectal cancer and cardiovascular disease
Participants - 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
Participants - 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
Anticipated start date 21/09/2010
Anticipated end date 20/09/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 316 participants (158 in each arm)
Interventions 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.
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
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
Sources of funding Medical Research Council (MRC) - National Prevention Research Initiative (NPRI) (UK) (ref: G0802030)
Trial website
Publications 2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21439044
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24351063
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24609919
Contact name Prof  Annie  Anderson
  Address 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
  City/town Dundee
  Zip/Postcode DD1 9SY
  Country United Kingdom
Sponsor University of Dundee (UK)
  Address 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
  City/town Dundee
  Zip/Postcode DD1 9SY
  Country United Kingdom
  Sponsor website: http://www.dundee.ac.uk/
Date applied 20/09/2010
Last edited 18/03/2014
Date ISRCTN assigned 07/02/2011
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