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
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
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).
Study Plan
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:
Ancillary studies
Complete aerobic training
Other Names:
Receive diet recommendations from health coach or registered dietitian
Other Names:
Complete high-resistance circuit training sessions
Other Names:
|
|
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:
Ancillary studies
Complete aerobic training
Other Names:
Receive diet recommendations from health coach or registered dietitian
Other Names:
Complete high-resistance circuit training sessions
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eligibility Rate
Time Frame: 4 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention Adherence
Time Frame: 4 months
|
Intervention adherence for an individual is defined as attending at least 22 of the sessions with the personal trainer and at least 11 of the health coaching sessions.
The intervention adherence at the study level is then defined by the percentage of participants adhering to the intervention.
Criteria for feasibility will be defined as a study intervention adherence rate of ≥ 75%
|
4 months
|
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Retention Rate
Time Frame: 8 months
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Retention will be assessed by the percentage of participants completing the 4-month study assessments.
Criteria for feasibility will be defined as a retention rate of ≥ 80% in each arm.
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8 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Karen M Basen-Engquist, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Skin Diseases
- Breast Diseases
- Skin and Connective Tissue Diseases
- Breast Neoplasms
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Nutrition Therapy
- Physical Conditioning, Human
- Exercise
- Resistance Training
- Diet Therapy
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
Studies a U.S. FDA-regulated device product
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