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Trial record 13 of 55 for:    cancer AND energy restriction

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03270111
Recruitment Status : Completed
First Posted : September 1, 2017
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE August 30, 2017
First Posted Date  ICMJE September 1, 2017
Last Update Posted Date February 6, 2019
Actual Study Start Date  ICMJE September 25, 2017
Actual Primary Completion Date July 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03270111 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women
Official Title  ICMJE High Energy Expenditure From Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer Female
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Supervised Exercise
    • Behavioral: Home-based Exercise
    • Behavioral: Reduced Energy Diet
    • Behavioral: Group Phone Calls
  • 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.
    Interventions:
    • Behavioral: Supervised Exercise
    • Behavioral: Home-based Exercise
    • Behavioral: Reduced Energy Diet
    • Behavioral: Group Phone Calls
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2018)
11
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2017)
25
Actual Study Completion Date  ICMJE July 24, 2018
Actual Primary Completion Date July 24, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03270111
Other Study ID Numbers  ICMJE STUDY00141301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Carol Fabian, MD, University of Kansas Medical Center
Study Sponsor  ICMJE Carol Fabian, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carol Fabian, MD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP