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UCLA Breast Cancer Survivor Health Promotion Research Study

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Brief Summary

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.

Primary Purpose
Prevention
Study Type
Interventional
Phase
N/A

Eligibility

Gender
Female
Healthy Volunteers
No
Minimum Age
50 Years
Maximum Age
75 Years

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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Study Stats
Protocol No.
21-001810
Category
Cancer Prevention & Control Research
Oncology
Principal Investigator
William McCarthy
Contact
William McCarthy
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05113485
For detailed technical eligibility, visit ClinicalTrials.gov.