An Exercise RCT Targeting African-American Women With Metabolic Syndrome and High Risk for Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Georgetown University
Sponsor:
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT02103140
First received: April 1, 2014
Last updated: May 6, 2014
Last verified: January 2014
  Purpose

Among African-American women, in whom metabolic syndrome (MetS) is very prevalent and breast cancer mortality rates are high, it is hypothesized that intervening on MetS to improve the MetS profile may prove to be a means to reduce breast cancer risk. Specific recommendations for breast cancer prevention are now focused on maintaining a healthy weight via increased physical activity levels, and losing weight if overweight or obese.

This pilot project compares two exercise interventions: a supervised facility-based and a home-based exercise intervention to a control group in African-American women with metabolic syndrome who are at high risk for breast cancer. This study is a 6-month three-arm RCT to assess the impact of the exercise interventions on biomarkers related to obesity, insulin-related pathways, inflammation, hormones, and micro-RNAs.

The specific aim of the proposed study is to compare the impact of a supervised facility-based and a home-based exercise intervention on obesity, metabolic syndrome and known breast cancer biomarkers in postmenopausal African-American women with metabolic syndrome who are at increased risk of breast cancer.


Condition Intervention Phase
Metabolic Syndrome
Obesity
Other: Exergaming
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: An Exercise Randomized Controlled Trial Targeting African-American Women With Metabolic Syndrome and High Risk for Breast Cancer

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Reduction in Breast Cancer Risk [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Reduction in Metabolic Syndrome components that are risk factors for breast cancer. MetS represents a cluster of risk factors associated with increased risk of cardiovascular diseases, and includes several components individually related to breast cancer etiology, i.e., central obesity, hypertension, hyperglycemia, and low high-density lipoprotein cholesterol. However, recent studies have suggested that MetS is underdiagnosed in African-American women because they are less likely to have decreased HDL or increased triglycerides as compared to women of other races/ethnicities. Breast cancer is hormone related and thus, the effects of established risk factors for the disease, including obesity, differ before to after menopause. Among African-American women, in whom MetS is very prevalent and breast cancer mortality rates are high, it is hypothesized that intervening on MetS to improve the MetS profile may prove to be a means to reduce breast cancer risk.


Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Facility-Based Exergaming
Supervised Facility-Based Exercise Intervention Arm The participants randomized to the exercise group will be required to meet and maintain a goal of 150 min/wk of moderate intensity exercise for 6 months. This intervention will use heart rate and rating of perceived exertion (RPE) to define moderate intensity. Participants will exercise for the prescribed duration at a heart rate in the range of 45-65% of their maximal oxygen consumption (VO2 max), as determined during baseline testing, and with an RPE in the range of 11-14 on the 20-point scale. The exercise will primarily utilize treadmills and exercise bikes.
Other: Exergaming
The participants randomized to the exercise group will be required to meet and maintain a goal of 150 min/wk of moderate intensity exercise for 6 months.
No Intervention: Control
After baseline testing, the control group will be asked to maintain their current daily activities and exercise habits for the duration of the study (6 months). The control group will have measurements at the same time periods as the participants in the intervention arm through the completion of the study. Participants will be seen for follow-up at 3 and 6 months (study completion). The participants in the control group will receive the same incentives as those in the intervention arms (gift cards). Since the women in the control group are obese, with components of metabolic syndrome, and at relatively high risk for breast cancer, we are providing healthy lifestyle information to the group, via text messages.
Experimental: Home-Based Exercise Intervention Group
Home-Based Exercise Intervention Group The participants randomized to this intervention arm will be required to meet and maintain a goal of 150 min/wk of moderate intensity exercise for 6 months, the same as the supervised intervention group. Their exercise goal will be to achieve a total of 10,000 steps per day, as measured by pedometers. Participants will be required to have a cell phone with text messaging capabilities.
Other: Exergaming
The participants randomized to the exercise group will be required to meet and maintain a goal of 150 min/wk of moderate intensity exercise for 6 months.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eligible participants should be female, African-American postmenopausal women between the ages of 45 and 65 with waist circumference greater than 35 inches (88 cm), 5-year invasive breast cancer risk is greater than 1.40% using the CARE model, and have at least one of the following:
  • elevated fasting glucose is greater than or equal to 100 mg/dL
  • elevated blood pressure is greater than or equal to 130/85 mm/Hg. In addition, they should also have a cell phone with texting capabilities, read and speak English, reside in close proximity to, or can access the Navy Yard stop on the green line, can provide meaningful consent, and medical clearance from a physician or nurse practitioner.

Exclusion Criteria:

  • -physical limitations that prevent participant from exercising
  • premenopausal
  • pregnant or planning to become pregnant within the next year
  • history of cancer (except for non-melanoma skin cancer)
  • have diabetes
  • use anti-diabetic medication (including insulin)
  • are currently enrolled in a physical activity and/or dietary clinical trial
  • are on a weight loss program
  • cannot commit to the intervention schedule
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02103140

Contacts
Contact: Lucile Adams-Campbell, PhD 2026875367 lla9@georgetown.edu

Locations
United States, District of Columbia
Georgetown Lombardi Office of Minority Health community site Recruiting
Washington, District of Columbia, United States, 20003
Contact: Nicket Lewis    202-687-5367    ntl@georgetown.edu   
Sponsors and Collaborators
Georgetown University
  More Information

No publications provided

Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT02103140     History of Changes
Other Study ID Numbers: 2012-012 Georgetown Lombardi
Study First Received: April 1, 2014
Last Updated: May 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
Breast Cancer
Obesity
African American female
exergaming

Additional relevant MeSH terms:
Breast Neoplasms
Obesity
Metabolic Syndrome X
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 22, 2014