Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Weight Loss

Body Weight

Breast Diseases

Skin Diseases

Participants will take part in supervised exercise and home-based exercise sessions. Participants will be asked to follow a specific diet. Participants will be asked to take part in weekly behavioral group phone calls.

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.

Supervised 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.

Home-based Exercise

Once weekly phone calls that are group-based. 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.

Group Phone Calls

Participants will consume a nutritionally balanced, reduced calorie diet as recommended by the Academy of Nutrition and Dietetics.

Diet

Carol Fabian, MD

The purpose of the study is to demonstrate that breast cancer survivors who need to lose weight are able to follow a weight loss program which combines modest calorie restriction with a graduated activity program..

Feasibility will be assessed by 1) the number of women that complete the 3--month program; 2) the number of women that can achieve the targeted amount of physical activity per week by the end of the program; and 3) the median amount of physical activity achieved group by all subjects that complete the program.

Feasibility of High Levels of Energy Expenditure From Physical Activity for Breast Cancer Survivors

Feasibility of High Levels of Energy Expenditure From Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors

Adherence is defined as the percent of monitored sessions at the YMCA attended by the participant.

Measured as percentage of participants meeting final physical activity goal between week 9 to week 12. Measurement based off activity tracker participants will wear.

Defined as number of participants attending at least 75% of the weekly group calls.

University of Kansas Medical Center

Professor, Director Breast Cancer Prevention Unit

Body Weight Changes

Participants will include breast cancer survivors who take part in a weight loss intervention program. The intervention is the same for all participants.

Participants will include women at high risk of breast cancer who take part in a weight loss intervention program. The intervention is the same for all participants.

Diet is a nutritionally balanced, reduced energy diet recommended by the Academy of Nutrition and Dietetics.

Reduced Energy Diet

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility of High Levels of Energy Expenditure From Physical Activity for Breast Cancer Survivors	NCT02963740	Breast Cancer F...	Supervised Exer... Home-based Exer... Group Phone Cal... Diet	- 71 Years	University of Kansas Medical Center
Feasibility of High Levels of Energy Expenditure From Physical Activity for Breast Cancer Survivors	NCT02963740	Breast Cancer F...	Supervised Exer... Home-based Exer... Group Phone Cal... Diet	- 71 Years	University of Kansas Medical Center
Feasibility of High Levels of Energy Expenditure From Physical Activity for Breast Cancer Survivors	NCT02963740	Breast Cancer F...	Supervised Exer... Home-based Exer... Group Phone Cal... Diet	- 71 Years	University of Kansas Medical Center
High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women	NCT03270111	Breast Cancer F...	Supervised Exer... Home-based Exer... Reduced Energy ... Group Phone Cal...	50 Years - 70 Years	University of Kansas Medical Center

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