Prevention of breast cancer in women at increased risk Cancer
Conditions
Interventions
A 12-week family-based behavioural weight-loss programme (B-FAM) delivered by a research dietitian. The programme provides:
- Personalised energy-reduced Mediterranean-style diet: Individual energy re
Sponsors
University of Manchester
Eligibility
Sex/Gender
Female
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Born female, no gender reassignment 2. Age =18 years 3. Moderate/high BC risk (=17% lifetime or =3% 10-year risk at age 40) per clinic assessment 4. BMI =25.0 kg/m² (=23.5 for ethnic minority groups) 5. Communicates in English/other supported language and has phone access 6. Can attend 2 face-to-face visits at MFT 7. Not pregnant/planning pregnancy in next 3 months; negative pregnancy test if indicated; agrees to contraception/abstinence 8. Family participation (potential willingness of the family members to take part as reported by the mother) 9. Co-resident dependent children aged 17 years or under
Exclusion criteria
Exclusion criteria: 1. Previous cancer diagnosis with exception of non-melanoma skin cancer or cervical intra-epithelial neoplasia 2. Currently pregnant or breastfeeding 3. Current GLP-1/GIP agonist use, other anti-obesity medications, or prior bariatric surgery 4. Medical/psychiatric conditions, in the view of the study clinician, making participation inappropriate or unsafe 5. Inability to consent 6. Inability to attend face-to-face and/or remote sessions 7. Current participation in other weight loss programmes/trials 8. Substance abuse or harmful alcohol use as indicated by a score of 16 or above on the Alcohol Use Disorders Identification Test (AUDIT) 9. Current or previous diagnosis of an eating disorder 10. Participants with severe binge eating assessed by a score of 27 or more on the Binge Eating Scale (BES) 11. Participants with severe depression assessed by a score of 15 or more on the Patient Health Questionnaire-9 (PHQ-9) questionnaire 12. Participants with severe anxiety assessed by a score of 15 or more on the General Anxiety Disorder (GAD-7) questionnaire
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Numbers invited and consented to the trial , measured using screening logs and consent logs at baseline 2. Numbers consented who complete the trial, measured using retention logs at week 12 3. Demographics of recruited mothers, measured using a demographic and diet-history questionnaire at baseline on Qualtrics (or paper forms) 4. Acceptability, measured using the validated intervention acceptability questionnaire (Sekhon et al., 2022) at week 12 on Qualtrics (or paper forms) 5. Engagement with sessions and family challenges, measured using dietitian CRFs documenting attendance at fortnightly calls and mother-reported family engagement across weeks 0–12 6. Dietitian time required per mother, measured using structured dietitian time-tracking forms completed at every dietitian contact point (weeks 0–12) | — |
Secondary
| Measure | Time frame |
|---|---|
| For participating mothers not for other family members: 1. Measured maternal weight and body composition; body fat and lean mass (assessed with bioelectrical impedance(Tanita 980 BIA)), waist, hip circumference measured by research dietitians measured at baseline and week 12. 2. Dietary intake, measured using a 7-day food diary via MyFood24® or paper diary at baseline, week 6, and week 12. 3. Mediterranean Diet Score, measured using the validated 14-item questionnaire at baseline, week 6, and week 12. 4. Physical activity, measured using IPAQ-Short Form at baseline, week 6, and week 12. Family endpoints (completed by the mother): 5. Family functioning, measured using the General Functioning subscale (GF) of the McMaster Family Assessment Device at baseline, week 6, and week 12. 6. Family Nutrition and Physical Activity (FNPA) questionnaire, measured at baseline, week 6, and week 12. | — |
Countries
England, United Kingdom
Contacts
Public ContactMai Haiba
Outcome results
None listed