Lifestyle Intervention for the Reduction of Breast Cancer Risk in Normal Weight Women
- 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 of at least 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)
- Not currently adhering to national physical activity guidelines (150 minutes per week of moderate intensity aerobic exercise or 75 minutes per week of vigorous intensity exercise, strength exercise twice a week)
- 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 mass greater than or equal to 9.4 kg as indicated by a dual X-ray absorptiometry (DXA) scan
- Height and weight indicating a BMI of at least 18.5 and < 25 kg/m^2 verified at the screening visit
- 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
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 ꞏ 9.4 kg, the 50th percentile of normal BMI women in the Women’s Health Initiative [WHI]).
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).
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.
Trial Phase Phase NA
Trial Type Prevention
M D Anderson Cancer Center
Karen M. Basen-Engquist
- Primary ID 2019-0634
- Secondary IDs NCI-2019-07636
- Clinicaltrials.gov ID NCT04267796