NCT03270111

High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women

High Energy Expenditure From Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Carol Fabian, MD · Academic / Other
• Sex: Female
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this second pilot study is to extend the feasibility demonstrated in NCT02963740 that the intervention achieves high levels of moderate to vigorous physical activity (MVI PA) and modulates risk biomarkers for breast cancer and cardiovascular disease in older, obese sedentary breast cancer survivors who are undergoing moderate calorie restriction.

Detailed description

All subjects participate in same intervention. Intervention consists of a 6-month structured weight loss program utilizing portion controlled meals and a prescribed level of graduated physical activity with an eventual goal of 200 minutes or more per week. The program will include twice weekly sessions with a trainer at a local YMCA, and weekly phone group sessions the first 3 months with transition to unsupervised exercise and less frequent group phone sessions the second 3 months.

Conditions

• Breast Cancer Female

Interventions

Type	Name	Description
BEHAVIORAL	Supervised Exercise	Participants will take part in supervised exercise activities two times per week at a YMCA. Length of the activity will be increased during participation in study. Participants will start at 40 minutes per week and work their way up to 120 minutes per week.
BEHAVIORAL	Home-based Exercise	Aerobic exercise activities to be completed at home. Participants will be asked to start out doing 60 minutes at home and work up to 180 minutes of purposeful aerobic home exercise per week.
BEHAVIORAL	Reduced Energy Diet	Diet is a nutritionally balanced, reduced energy diet recommended by the Academy of Nutrition and Dietetics.
BEHAVIORAL	Group Phone Calls	Sessions are weekly months 1-3 and every other week months 4-6. The calls will discuss lifestyle changes specific to participants and cover the effects of diet, physical activity, and weight on breast cancer risk, as well as body image and emotional eating.

Timeline

• Start date: 2017-09-25
• Primary completion: 2018-07-24
• Completion: 2018-07-24
• First posted: 2017-09-01
• Last updated: 2024-12-18

Locations

1 site across 1 country: United States