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

December 16, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carol Fabian, MD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 24, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 24, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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