UCLA Breast Cancer Survivor Health Promotion Research Study

NCT05113485 | Unknown DMC

• 1 other identifier: B27IB3856
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

obesity; physical activity; fiber diversity; calorie restriction; inflammation

Outcome Measures

Primary Outcomes (1)

• High-sensitivity C-Reactive Protein (CRP)

  CRP is commonly used by researchers as a biomarker for systemic inflammation.

  Change from baseline to 6 months follow-up

Secondary Outcomes (3)

• Visceral fat as assessed by DXA

  Change from baseline to six months follow-up

• Shannon index of alpha diversity of fecal microbial species

  Change from baseline to six months follow-up

• Number of highly microbiota-accessible foods consumed per day

  Change from baseline to six months follow-up

Other Outcomes (7)

• Insulin resistance

  Change from baseline to six months follow-up

• Waist circumference

  Change from baseline to six months follow-up

• Body mass index (BMI)

  Change from baseline to six months follow-up

Study Arms (2)

Diabetes Prevention Program-based lifestyle change intervention (DPP)

ACTIVE COMPARATOR

The Diabetes Prevention Program-based lifestyle change intervention (DPP) is designed to help overweight breast cancer survivors to reduce their risk of breast cancer recurrence by reducing their excess body fat.

Behavioral: Diabetes Prevention Program-based lifestyle change intervention (DPP)

Highly Microbiota-Accessible Foods (HMAFs) intervention

EXPERIMENTAL

The Highly Microbiota-Accessible Foods (HMAFs) lifestyle change intervention is designed to help overweight breast cancer survivors reduce their risk of breast cancer recurrence by reducing their elevated low-grade inflammation.

Behavioral: Highly Microbiota-Accessible Foods (HMAFs) intervention

Interventions

Diabetes Prevention Program-based lifestyle change intervention (DPP) BEHAVIORAL

The DPP condition consists of 11 health education sessions over 12 weeks, including 2 virtual home visits, two virtual group education sessions and 7 telephone coaching calls. These sessions will teach DPP-based lessons on how to lose excess body fat through calorie restriction and increased physical activity. All dietary and physical activity recommendations are intended to be consistent with federal nutrition and physical activity guidelines.

Diabetes Prevention Program-based lifestyle change intervention (DPP)

Highly Microbiota-Accessible Foods (HMAFs) intervention BEHAVIORAL

The Highly Microbiota-Accessible Foods (HMAFs) intervention approach includes 11 health education sessions, including two virtual home visits, two virtual group education sessions, and 7 telephone coaching sessions. These sessions are designed to help study participants to identify and consume optimally 6 daily instances of minimally processed, fiber-rich food sources, drawn from all four of the MyPlate.gov categories: vegetables, fruits, whole grains and plant-based protein-rich foods (e.g., legumes, nuts and seeds). Increased physical activity is also recommended as a way to optimize the microbial conversion of fiber-rich food sources to short chain fatty acids, which are then expected to reduce excess low-grade inflammation.

Highly Microbiota-Accessible Foods (HMAFs) intervention

Eligibility Criteria

• Age: 50 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Center for Cancer Prevention & Control Research

Los Angeles, California, 90095-6900, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Obesity; Motor Activity; Inflammation

Interventions

Methods

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Pathologic Processes

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• William J. McCarthy

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William J. McCarthy, Ph.D.

CONTACT

3107947587; wmccarth@ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All assessments will be conducted by project personnel blind to the study participants' randomization status. The investigators responsible for helping participants complete the Automated Self-administered 24-hour (ASA 24) dietary recalls and for assessing their body composition via dual x-ray absorptiometry (DXA) will be kept blind to the study participants' randomization status. Investigators will be kept blind to participant assignment to condition by having the two health coaches refer to their patients by an arbitrary, unique study identifier during weekly debriefings when the study progress by individual participants might be discussed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Model Details: The two lifestyle change interventions feature a similar exercise prescription and the same sequence of intervention contacts (2 virtual home visits; 2 virtual group education sessions, 7 individual telephone coaching sessions) but differ in dietary approach. The DPP-based diet approach prescribes desired weight loss in overweight breast cancer survivors by restricting daily calorie intake and promoting increased calorie expenditure via physical activity. The HMAFs approach prescribes consuming an optimal six microbiota-accessible foods unaccompanied by pro-inflammatory food components such as saturated fat or added sugar as well as engaging regularly in exercise that elevates the heart rate and reduces inflammation. Only 20 percent of daily calories need to be devoted to HMAFs; the remaining calories can come from daily food choices conforming to the 2020-2025 Dietary Guidelines for Americans.

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 9, 2021
• Study Start: April 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will become available 1 year after the completion of the final report.
• Access Criteria: Bona fide researchers as determined by the University of California-Los Angeles (UCLA) Institutional Review Board (IRB) will be eligible to use the data.

Locations

US (1)