M D Anderson Cancer Center
Houston, Texas, 77030, United States
NCT Number: NCT04267796
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.
This study is active but is not currently recruiting participants.
Notify Me50 year–69 year
Female
Interventional
Not applicable
Houston, Texas, 77030, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Ancillary studies
Other names: Quality of Life Assessment
Ancillary studies
Complete high-resistance circuit training sessions
Other names: Strength Training
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%
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%
Time frame: 8 months
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.
M.D. Anderson Cancer Center
Other
Reducing Breast Cancer Risk Through Modifying Body Composition and Decreasing Inflammation in Normal Weight Women
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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