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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Carcinoma

Intervention / Treatment
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* Other: Aerobic Exercise
* Other: Dietary Intervention
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Other: Resistance Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (lifestyle intervention)<br>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. | Other: Aerobic Exercise<br>* Complete aerobic training<br>* Other names: Aerobic Activity;Other: Dietary Intervention<br>* Receive diet recommendations from health coach or registered dietitian<br>* Other names: Nutritional Interventions;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Resistance Training<br>* Complete high-resistance circuit training sessions<br>* Other names: Strength Training;|
| Active Comparator: Group II (wait-list, lifestyle intervention)<br>Participants are placed on a wait-list and then complete lifestyle intervention after 4 months. | Other: Aerobic Exercise<br>* Complete aerobic training<br>* Other names: Aerobic Activity;Other: Dietary Intervention<br>* Receive diet recommendations from health coach or registered dietitian<br>* Other names: Nutritional Interventions;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Resistance Training<br>* Complete high-resistance circuit training sessions<br>* Other names: Strength Training;|

What is the study measuring?
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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. | 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. | Will assessed by the calculated rates, frequencies, and 95% confidence intervals (CIs) for these measures | up to 16 weeks |