- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03270111
High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women
January 9, 2022 updated by: Carol Fabian, MD
High Energy Expenditure From Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Diagnosis of breast cancer having completed any cytotoxic chemotherapy, radiation or surgery at least 3 months prior to study entry (Cohort A2) OR No prior diagnosis of breast cancer but at high risk for development of breast cancer and participating in HSC 4601 (Cohort B)
- 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:
- Use of metformin, insulin, steroids or prescription weight loss or anti-psychotic drugs within the prior 3 weeks
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
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.
Diet is a nutritionally balanced, reduced energy diet recommended by the Academy of Nutrition and Dietetics.
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.
|
Experimental: 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.
|
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.
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.
Diet is a nutritionally balanced, reduced energy diet recommended by the Academy of Nutrition and Dietetics.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent participants meeting physical activity goal
Time Frame: 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.
|
Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carol Fabian, MD, University of Kansas Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 25, 2017
Primary Completion (Actual)
July 24, 2018
Study Completion (Actual)
July 24, 2018
Study Registration Dates
First Submitted
August 30, 2017
First Submitted That Met QC Criteria
August 30, 2017
First Posted (Actual)
September 1, 2017
Study Record Updates
Last Update Posted (Actual)
January 25, 2022
Last Update Submitted That Met QC Criteria
January 9, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00141301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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