Topic: Cancer
Conditions
Interventions
172 overweight women currently enrolled on the PROCAS Study will be randomly assigned to a weight loss / lifestyle programme with either:
1. A standard care group (n = 40)
Sponsors
University Hospital of South Manchester NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Attending the NHSBSP aged 47 - 74 years and part of the PROCAS study 2. Women who have previously received feedback of their personalised breast cancer risk by phone / face to face / letter 3. BMI =25 kg/m2 as breast cancer risk is seen amongst overweight as well as obese women 4. Access to and ability to use a telephone and high/moderate-speed internet 5. Women in the North, Central and South Manchester Clinical Commissioning Groups who are eligible for NHS health check with Public Health Manchester 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 diabetes or high risks of these diseases to receive appropriate follow up tests and medical management.
Exclusion criteria
Exclusion criteria: Exclusion criteria as of 03/11/2016: 1. Previous diagnosis of cancer, diabetes, CVD or receiving medication for raised cholesterol. Women with previous non-melanoma skin cancer or cervical intra-epithelial neoplasia will be accepted. 2. Physical or psychiatric condition which precludes suitability or adherence to a home-based diet and exercise programme 3. Current user of hormone replacement therapy (weight affects breast cancer risk amongst non-HRT users only) 4. Advanced renal failure and attending a pre dialysis clinic. 5. Currently successfully following a diet and/or exercise plan and have lost more than 2 lb (1 kg) of weight in the last 2 weeks Original exclusion criteria: 1. Previous diagnosis of cancer, diabetes, CVD or receiving medication for raised cholesterol 2. Physical or psychiatric condition which precludes suitability or adherence to a home-based diet and exercise programme 3. Current user of hormone replacement therapy (weight affects breast cancer risk amongst non-HRT users only)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight, body fat and fat-free mass are measured at baseline, 3 and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Biomarkers of CVD (lipids, systolic and diastolic blood pressure), diabetes (HbA1c) are measured at baseline, 3 and 6 months 2. Quality of life is measured using the SF-36 questionnaire at baseline, 3 and 6 months 3. Health status is measured using the EQ-5D questionnaire at baseline, 3 and 6 months | — |
Countries
England, United Kingdom
Outcome results
None listed