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

Not Applicable

Recruiting

• Conditions: Breast Carcinoma
• Interventions: Other: Aerobic Exercise; Other: Dietary Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Resistance Training

• Registration Number: NCT04267796
• Lead Sponsor: M.D. Anderson Cancer Center

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.

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 Timeline

• Study First Submitted: 2019-11-26
• Study Start: 2020-01-10
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-13
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-05
• Last Update Posted: 2024-07-09
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• 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

Read More

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 (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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (wait-list, lifestyle intervention)	Questionnaire Administration	Participants are placed on a wait-list and then complete lifestyle intervention after 4 months.
Group I (lifestyle intervention)	Quality-of-Life Assessment	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 I (lifestyle intervention)	Resistance Training	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 (wait-list, lifestyle intervention)	Aerobic Exercise	Participants are placed on a wait-list and then complete lifestyle intervention after 4 months.
Group II (wait-list, lifestyle intervention)	Resistance Training	Participants are placed on a wait-list and then complete lifestyle intervention after 4 months.
Group I (lifestyle intervention)	Questionnaire Administration	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 (wait-list, lifestyle intervention)	Quality-of-Life Assessment	Participants are placed on a wait-list and then complete lifestyle intervention after 4 months.
Group II (wait-list, lifestyle intervention)	Dietary Intervention	Participants are placed on a wait-list and then complete lifestyle intervention after 4 months.
Group I (lifestyle intervention)	Aerobic Exercise	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 I (lifestyle intervention)	Dietary 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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States