UCLA Breast Cancer Survivor Health Promotion Research Study
Pilot randomized controlled parallel group behavior change comparative effectiveness trial involves 30 breast cancer survivors interested in losing excess body fat. Both interventions include dietary + exercise prescriptions that hold promise for reducing the survivors' risk of cancer recurrence. Both interventions are consistent with the Dietary Guidelines for Americans but the Diabetes Prevention Program (DPP)-based approach focuses on weight loss through calorie restriction and increased physical activity while the Highly Microbiota-Accessible Foods (HMAFs) approach is intended to be a low-numeracy version of a Mediterranean-style diet and increased physical activity. The DPP approach is considered to be a high-numeracy intervention because it requires that consumers keep track of all calories consumed and expended per day and to endeavor to maintain a calorie deficit each day during the active weight loss phase. For both conditions, the 12 to 13-week intervention includes 2 virtual home visits, 2 virtual group education sessions and 7 telephone or Zoom-based coaching sessions by well-trained intervenors. Assessments occur at baseline and six months, with systemic inflammation (high sensitivity C-reactive protein) being the primary outcome measure and visceral fat being a secondary outcome. Other prespecified secondary outcomes include gut microbiota alpha-1 diversity, insulin resistance, HDL-cholesterol, daily count of highly microbiota-accessible foods, waist circumference, BMI, systolic blood pressure, ratio of fecal Proteobacteria to short chain fatty acid-generating bacteria and health-related quality of life.
- At least 6 months since breast cancer diagnosis and up to 4 years since diagnosis.
- Between 50 and 75 years of age.
- Diagnosed with localized steroid hormone receptor-positive breast cancer, up to stage IIIa.
- At least 6 months post chemotherapy or radiation treatment.
- Subjects must be in good health as determined by medical history, physical examination, and clinical laboratory measurements.
- No broad-spectrum antibiotic use in the last two months.
- Body mass index between 27 and 38 based on self-reported height and weight and between 25 and 40 based on objective assessment of height and weight.
- Willing to complete assessments at baseline, 3 months and 6 months follow-up
- Diagnosed with metastatic breast cancer
- Currently undergoing chemotherapy or radiation treatment
- Immunoglobulin-E (IgE)-mediated food allergies, or any medical condition requiring mandatory dietary restrictions
- Significant cardiac, pulmonary, renal, liver or psychiatric disease.
- Muscular, orthopedic, or cardiovascular limitations that would prevent full participation in exercise