Lifestyle Intervention for the Reduction of Breast Cancer Risk in Normal Weight Women
Reducing Breast Cancer Risk Through Modifying Body Composition and Decreasing Inflammation in Normal Weight Women
2 other identifiers
interventional
40
1 country
1
Brief Summary
This trial studies how well a lifestyle intervention works in reducing breast cancer risk through changing body composition and decreasing inflammation in normal weight women. This trial may help researchers learn more about diet and exercise programs designed to decrease body fat in postmenopausal women who are of normal weight but have an elevated risk of breast cancer because of excess body fat.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2019
CompletedFirst Posted
Study publicly available on registry
February 13, 2020
CompletedStudy Start
First participant enrolled
June 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2025
CompletedResults Posted
Study results publicly available
April 16, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedApril 16, 2026
April 1, 2026
4 years
November 26, 2019
March 26, 2026
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Eligibility Rate
Eligibility rate will be calculated as the number of eligible women identified divided by the total number completing a DXA scan. Criteria for feasibility will be defined as an eligibility rate of ≥ 40%
4 months
Secondary Outcomes (2)
Intervention Adherence
4 months
Retention Rate
8 months
Study Arms (2)
Group I (lifestyle intervention)
EXPERIMENTALParticipants complete lifestyle intervention consisting of 1-3 sets of high-resistance circuit training sessions per week, up to 150 minutes of aerobic training per week, and diet recommendations from a health coach or registered dietitian twice per week for 16 weeks.
Group II (wait-list, lifestyle intervention)
ACTIVE COMPARATORParticipants are placed on a wait-list and then complete lifestyle intervention after 4 months.
Interventions
Complete aerobic training
Receive diet recommendations from health coach or registered dietitian
Ancillary studies
Ancillary studies
Complete high-resistance circuit training sessions
Eligibility Criteria
You may qualify if:
- Age 50-69 years old
- Postmenopausal woman (absence of menstruation for at least one year, or history of bilateral oophorectomy)
- Self-reported height and weight indicating a BMI \>= 18.5 and \< 25 kg/m\^2
- No contraindications to exercise (either no positive responses on the Physical Activity Readiness Questionnaire, or clearance from a health care provider certifying that the participant is healthy enough to exercise)
- No history of invasive cancer, other than non-melanoma skin cancer
- No history of renal disease
- Able to walk without an assistive device
- Not within 3 months of major surgery
- Able to speak/read/write in English
- Has internet access on a computer or mobile device
- A trunk fat mass \>= 9.4 kg as indicated by a dual x-ray absorptiometry (DXA) scan
- Height and weight indicating a BMI of \>= 18.5 and \< 25 kg/m\^2 verified at the screening visit
You may not qualify if:
- MD Anderson employees that report to the principal investigator of this study
- Participants that cannot engage in the exercise program for more than three weeks during the study period
- Participants that are currently doing strength exercises that work all major muscle groups (defined as: participants who complete more than 16 repetitions per exercise in their current resistance training regimen, or who don't find their last 1-2 reps to be difficult in their current regimen, or who increase the weight in their current routine).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
- Foundation for Women's Cancerscollaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Karen M Basen-Engquist
- Organization
- The University of Texas MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Karen M Basen-Engquist
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2019
First Posted
February 13, 2020
Study Start
June 25, 2021
Primary Completion
June 13, 2025
Study Completion (Estimated)
July 1, 2026
Last Updated
April 16, 2026
Results First Posted
April 16, 2026
Record last verified: 2026-04