Lifestyle Intervention for the Reduction of Breast Cancer Risk in Normal Weight Women

September 1, 2023 updated by: M.D. Anderson Cancer Center

Reducing Breast Cancer Risk Through Modifying Body Composition and Decreasing Inflammation in Normal Weight Women

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.

Study Overview

Detailed Description

PRIMARY OBJECTIVE:

I. Evaluate the feasibility of a diet and exercise intervention to decrease body fat in postmenopausal women with normal body mass index (BMI) but high body fat (trunk fat mass 9.4 kg, the 50th percentile of normal BMI women in the Women's Health Initiative [WHI]).

SECONDARY OBJECTIVE:

I. Assess preliminary efficacy of the intervention by evaluating the post-intervention differences between the intervention and control groups in:

IIa. Circulating markers of inflammation and metabolic dysfunction linked to both excess adiposity and breast cancer (high sensitivity C-reactive protein [hsCRP], fasting insulin, leptin, IL-6, triglycerides, sex hormone binding globulin [SHBG], adiponectin, and high density lipoprotein [HDL] cholesterol).

IIb. Body composition body fat, trunk fat mass, fat mass, lean mass, fat-free mass).

EXPLORATORY OBJECTIVE:

I. Exploratory outcomes include fitness (oxygen consumption VO2 peak, sit-to-stand test), behavior (physical activity, energy intake, macronutrient consumption), and quality of life (global health-related quality of life, physical functioning, sleep, menopausal symptoms).

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants 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: Participants are placed on a wait-list and then complete lifestyle intervention after 4 months.

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
          • Karen M. Basen-Engquist
          • Phone Number: 713-745-3123
        • Principal Investigator:
          • Karen M. Basen-Engquist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Employee at MD Anderson Cancer Center
  • 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

Exclusion Criteria:

  • 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 wo or more times per week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I (lifestyle intervention)
Participants 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.
Ancillary studies
Other Names:
  • Quality of Life Assessment
Ancillary studies
Complete aerobic training
Other Names:
  • Aerobic Activity
Receive diet recommendations from health coach or registered dietitian
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions
Complete high-resistance circuit training sessions
Other Names:
  • Strength Training
Active Comparator: Group II (wait-list, lifestyle intervention)
Participants are placed on a wait-list and then complete lifestyle intervention after 4 months.
Ancillary studies
Other Names:
  • Quality of Life Assessment
Ancillary studies
Complete aerobic training
Other Names:
  • Aerobic Activity
Receive diet recommendations from health coach or registered dietitian
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions
Complete high-resistance circuit training sessions
Other Names:
  • Strength Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the feasibility of a diet intervention to decrease body fat in postmenopausal women with normal BMI but high body. fat.
Time Frame: up to 16 weeks
Will assessed by the calculated rates, frequencies, and 95% confidence intervals (CIs) for these measures
up to 16 weeks
Evaluate the exercise intervention to decrease body fat in postmenopausal women with normal BMI but high body. fat.
Time Frame: up to 16 weeks
Will assessed by the calculated rates, frequencies, and 95% confidence intervals (CIs) for these measures
up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Karen M Basen-Engquist, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2021

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

November 26, 2019

First Submitted That Met QC Criteria

February 10, 2020

First Posted (Actual)

February 13, 2020

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2019-0634 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2019-07636 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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