Breast cancer Cancer Breast cancer
Conditions
Interventions
209 overweight/obese women in 3 UK NHS family history clinics are randomly assigned to one of 2 different 12 month weight loss/lifestyle programmes or a group receiving written advice:
1. A written ad
Sponsors
University Hospital of South Manchester NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Receiving annual or 18 monthly mammograms in the FHC (aged > 30 years) ), or as part of a mammographic surveillance programme for increased familial risk of BC 2. Have previously received information on their risk of developing BC within the FHC 2. Overweight / obese (BMI = 25 kg/m2) 3. Access to the internet and telephone 4. Ability to understand English and complete trial paperwork as successful participation requires engagement with weekly tailored e-mails and an interactive patient forum 5. Participants must be willing to follow a diet and physical activity plan with the aim of losing weight 6. Agree that results of any NHS Health Checks conducted in the study can be communicated back to their GP. This is a requirement of NHS Health Checks to allow patients with undiagnosed CVD or T2DM or high risks of these diseases to receive appropriate follow up tests and medical management. 7. Assessed as safe to undertake a home based moderate intensity physical activity programme according to the physical activity readiness questionnaire (PAR-Q) +/- clearance from GP where appropriate 8. Women taking chemoprevention for BC, e.g. tamoxifen, raloxifine or aromatase inhibitors are eligible to join the trial
Exclusion criteria
Exclusion criteria: 1. Only one woman per family is able to join the study to avoid contamination between the groups 2. Previous diagnosis of cancer with the exception of previous non-melanoma skin cancer or cervical intra-epithelial neoplasia 3. Previous diagnosis of cardiovascular disease i.e. stroke, transient ischaemic attack (TIA), angina, heart attack, heart failure or ventricular or aortic aneurysm 4. Currently prescribed statins for raised cholesterol 5. Current diagnosis of T2DM 6. Current physical co-morbidity or hypertension which makes the patients unsuitable for a home based moderate physical activity programme as assessed with a positive PAR-Q score and opinion of the patients general practitioner for example; unstable angina, resting systolic BP > 160 resting diastolic BP > 100 mmHg with or without medication, a significant drop in blood pressure during physical activity, uncontrolled tachycardia> 100 bpm at rest, uncontrolled arrhythmia 7. Previous diagnosis of borderline personality disorder, bipolar psychotic disorder, or self-harm. 8. Currently prescribed antipsychotics i.e. Aripiprazole, Clozapine, Olanzapine, Quetiapine, Risperidone as these can cause excessive weight gain 9. Current alcohol or drug dependency 10. People requiring highly specialist medical diets which cannot be adjusted to fit with a weight loss diet i.e. phenylketonuria, maple syrup urine disease, glycogen storage diseases, and urea cycle disorders advanced kidney disease, advanced liver disease 11. Currently pregnant, breast feeding or planning pregnancy in the next 12 months 12. Patients who are currently on treatment with Orlistat for weight loss or who have previously had bariatric surgery for weight loss including gastric bypass and sleeve gastrectomy 13. Current diagnosis of kidney disease 14. Patients with a diagnosis of an eating disorder (e.g. binge eating or bulimia) 15. Currently successfully following a diet and/or physical activity plan and have lost more than 2 lb (1 kg) of weight in the last 2 weeks 16. Currently or previously on the PROCAS (Predicting Risk of Breast Cancer at Screening) Study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage weight loss is measured using Tanita 180 bioelectrical impedance scales at baseline, 6 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health behaviours is measured using the questionnaire “Mediterranean diet score” “IPAQ” and “Alcohol and Smoking” at baseline, 3 months, 6 months and 12 months and an optional physical activity monitor an baseline and 12 months 2. Change in body composition is measured using Tanita 180 bioelectrical impedance scales at baseline, 6 months and 12 months 3. Blood pressure is measured using a blood pressure monitor at baseline, 6 months and 12 months 4. Diet behaviour is measured using the questionnaire “Mediterranean diet score” at baseline, 3 months, 6 months and 12 months 5. Physical Activity is measured using the questionnaire “IPAQ” at baseline, 3 months, 6 months and 12 months and an optional physical activity monitor an baseline and 12 months 6. Quality of life is measured using the questionnaire “EQ-5D-5L”, ICE-CAP-A” and “health Resource Use” at baseline, 6 months and 12 months 7. Disease Risk perception is measured using the questionnaire “Study beliefs and Behaviours” at baseline, 6 months and 12 months 8. The impact of the three interventions on Health status and well-being is measured using the questionnaire “EQ-5D-5L” and ICE-CAP-A”” at baseline, 6 months and 12 months 9. Use of healthcare resources is measured using the questionnaire “health Resource Use” at baseline, 6 months and 12 months 10. The fidelity of the delivery of the Breast Cancer Prevention Programme and Multiple Disease Prevention Programme programmes is measured using the study phone call and email CRF 11. Behaviour change is measured using the questionnaire “Study beliefs and Behaviours” at baseline, 6 months and 12 months 12. Mammographic density is measured using automated volumetric and area based density analysis and visual assessment by a consultant radiologist at baseline and 12 months 13. The views of women using the programmes is measured using qualitative thematic analysis of a semi structured interview after 12 months | — |
Countries
England, United Kingdom
Contacts
Public ContactMichelle Harvie
Outcome results
None listed