Feasibility of High Levels of Energy Expenditure From Physical Activity for Breast Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT02963740|
Recruitment Status : Completed
First Posted : November 15, 2016
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Female||Behavioral: Supervised Exercise Behavioral: Home-based Exercise Behavioral: Group Phone Calls Behavioral: Diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of High Levels of Energy Expenditure From Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors|
|Study Start Date :||November 2016|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
Experimental: Weight Loss Intervention Group
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.
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: Group Phone Calls
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.
Participants will consume a nutritionally balanced, reduced calorie diet as recommended by the Academy of Nutrition and Dietetics.
- Adherence to supervised exercise sessions [ Time Frame: Week 12 ]Adherence is defined as the percent of monitored sessions at the YMCA attended by the participant.
- Percent participants meeting physical activity goal [ Time Frame: Week 9 to Week 12 ]Measured as percentage of participants meeting final physical activity goal between week 9 to week 12. Measurement based off activity tracker participants will wear.
- Compliance with group telephone sessions [ Time Frame: Week 12 ]Defined as number of participants attending at least 75% of the weekly group calls.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02963740
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Carol Fabian, MD||University of Kansas Medical Center|