BREAST cancer risk reduction through FAMily-based lifestyle change v1
Research type
Research Study
Full title
A single-arm feasibility trial of a family-based weight loss intervention for weight loss among mothers with overweight or obesity identified at moderate-high risk of breast cancer
IRAS ID
364154
Contact name
Michelle Harvie
Contact email
Sponsor organisation
University of Manchester
ISRCTN Number
ISRCTN10436313
Duration of Study in the UK
0 years, 7 months, 3 days
Research summary
Breast cancer is the most common cancer in women and living with overweight/obesity increases the risk. Research shows that losing even 5-10% of body weight can reduce breast cancer risk. However, many women and especially mothers find it difficult to lose weight while balancing family, work and childcare. Family dynamics, routines and the home food environment can strongly influence the women's success in achieving a healthy weight.
This study aims to test whether a family based weight loss programme is acceptable and practical for mothers with overweight or obesity who are identified as having increased breast cancer risk by within the NHS family history clinic. The B-FAM programme (BREAST cancer risk reduction through FAMily-based lifestyle change) encourage mothers to lead healthy changes at home using strategies such as self-monitoring, meal planning and building family support.
We aim to invite 15-20 mothers aged 18 or older who live with children aged 17 or under to take part. Each mother will receive 12 weeks of dietitians-led support by phone or video call. The mother's diet will be based on a healthy, energy-reduced Mediterranean-style pattern rich in fruit, vegetables, whole grains, and lean protein, and low in processed foods, sugary drinks, and alcohol. Physical activity will be encouraged to reach at least 150 minutes of moderate exercise per week.
Suitability and safety to undertake an unsupervised home based physical activity programme will be assessed using the Physical Activity Readiness questionnaire (PAR-Q) (46). This will be completed during the baseline assessments. If mothers answer yes to one or more of the seven physical activity screening questions, they will be asked to consult with their GP regarding any physical activity restrictions they may have. A GP letter of authorisation will need to be completed as appropriate before any trial related physical activity can commence
Participating mothers will attend 2 clinic visits at Wythenshawe Hospital at baseline and after 12 weeks for body measurements and questionnaires about diet, activity and family habits.
The study aims to evaluate recruitment, retention and satisfaction with the programme to inform further progression of a larger clinical trial. It's sponsored by Manchester University and funded by NIHR Manchester Biomedical Research Centre.REC name
London - Fulham Research Ethics Committee
REC reference
26/LO/0083
Date of REC Opinion
5 Mar 2026
REC opinion
Further Information Favourable Opinion