ISRCTN - ISRCTN53033856: BeWEL: the impact of a bodyweight and physical activity intervention on adults at risk of developing colorectal adenomas

Plain English Summary

http://cancerhelp.cancerresearchuk.org/trials/a-study-to-assess-impact-of-lifestyle-advice-to-people-who-have-had-a-bowel-adenoma-removed-bewel

Trial website

Contact information

Type

Scientific

Primary contact

Prof Annie Anderson

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2009ON07; G0802030

Study information

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

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.

Ethics approval

Tayside Committee on Medical Research Ethics B Research Ethics Committee, 23/07/2010, ref: 10/S1402/34

Study design

Two-arm multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

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 trial start date

21/09/2010

Overall trial end date

20/09/2012

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

316 participants (158 in each arm)

Participant 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

Recruitment start date

21/09/2010

Recruitment end date

20/09/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Dundee
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

Sponsor type

University/education

Website

http://www.dundee.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) - National Prevention Research Initiative (NPRI) (UK) (ref: G0802030)

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