High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women
NCT ID: NCT03270111
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2017-09-25
2018-07-24
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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A2: Breast Cancer Survivor
Participants will include breast cancer survivors who take part in a weight loss intervention program. The intervention is the same for all participants.
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.
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.
Reduced Energy Diet
Diet is a nutritionally balanced, reduced energy diet recommended by the Academy of Nutrition and Dietetics.
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.
B: High Risk Women
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.
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.
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.
Reduced Energy Diet
Diet is a nutritionally balanced, reduced energy diet recommended by the Academy of Nutrition and Dietetics.
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.
Interventions
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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.
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.
Reduced Energy Diet
Diet is a nutritionally balanced, reduced energy diet recommended by the Academy of Nutrition and Dietetics.
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.
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) \>30 kg/m2. Women with a BMI \> 45 kg/m2 must be age \< 60 and ability to perform physical activity must be confirmed
* By self-assessment, currently performing 60 minutes or less of purposeful exercise per week but able to walk at least 30 minutes on a level surface
* Possession of smart phone capable of running MyFitnessPal and Garmin Connect apps and willing to have diet and exercise data accessed by study personnel
* Access to a personal computer
* Live in the greater Kansas City Metropolitan Area
* Willing and able to perform moderate intensity exercise at least 5 days per week for 6 months. This consists of a supervised exercise intervention at one of the 15 YMCAs affiliated with our program for 2 days per week. Must be willing to perform unsupervised home exercise for the entire 6 months.
* Willing to participate in a weekly behavioral modification group phone call for first 3 months and every 2 weeks for the second 3 months
* Willing to participate in a controlled dietary intervention with portion controlled meals and partial meal replacements plus 35 servings of fruits and vegetables/week for 6 months and track food intake and exercise
* Blood tests (Cohort A2) must have been performed after completion of any breast cancer surgery, radiation therapy, or cytotoxic chemotherapy, with reasonably normal liver and renal function as well as a hemoglobin of 10 or higher and/or performed within a year of study entry
Exclusion Criteria
* Individuals with prior gastric bypass surgery or procedure that would impair absorption of nutrients
* Need for chronic immunosuppressive drugs
* Participation within the past 6 months on a structured weight loss program such as Weight Watchers®
* Physical impairments (bad hip, knees, feet, peripheral neuropathy) that would prohibit performing moderate intensity exercise at least 5 days per week.
* Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for participation in the trial such as recent cardiac event
* Currently receiving investigational agents in a clinical trial
50 Years
70 Years
FEMALE
Yes
Sponsors
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Carol Fabian, MD
OTHER
Responsible Party
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Carol Fabian, MD
Professor, Director Breast Cancer Prevention Unit
Principal Investigators
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Carol Fabian, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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References
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Fabian CJ, Klemp JR, Marchello NJ, Vidoni ED, Sullivan DK, Nydegger JL, Phillips TA, Kreutzjans AL, Hendry B, Befort CA, Nye L, Powers KR, Hursting SD, Giles ED, Hamilton-Reeves JM, Li B, Kimler BF. Rapid Escalation of High-Volume Exercise during Caloric Restriction; Change in Visceral Adipose Tissue and Adipocytokines in Obese Sedentary Breast Cancer Survivors. Cancers (Basel). 2021 Sep 28;13(19):4871. doi: 10.3390/cancers13194871.
Other Identifiers
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STUDY00141301
Identifier Type: -
Identifier Source: org_study_id