NCT02103140

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
213

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

11.7 years

First QC Date

April 1, 2014

Last Update Submit

February 15, 2024

Conditions

Metabolic SyndromeObesity

Keywords

Breast CancerObesityAfrican American femaleexergaming

Outcome Measures

Primary Outcomes (6)

  • Waist circumference

    Reduction in waist circumference

    6 months

  • Body Mass Index

    Reduction in body mass index

    6 months

  • Biomarkers of breast cancer risk - biomarkers of inflammation

    Serum IL-6, TNF-alpha, High sensitivity CRP

    6 months

  • Biomarkers of breast cancer risk - biomarkers of insulin pathway

    Fasting glucose, seruminsulin, IGF-1, IGFBP-3

    6 months

  • Biomarkers of breast cancer risk - adipokines

    Serum leptin and adiponectin

    6 months

  • Metabolic syndrome

    Greater improvements in metabolic syndrome and metabolic syndrome components

    6 months

Secondary Outcomes (3)

  • Cardiorespiratory fitness

    6 months

  • Body composition

    6 months

  • Health-related Quality of Life

    6 months

Study Arms (3)

Facility-Based Exercise Intervention

EXPERIMENTAL

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.

Behavioral: Facility-based Exercise

Control

NO INTERVENTION

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.

Home-Based Exercise Intervention

EXPERIMENTAL

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.

Behavioral: Home-based Exercise

Interventions

Facility-based ExerciseBEHAVIORAL

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.

Facility-Based Exercise Intervention
Home-based ExerciseBEHAVIORAL

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.

Home-Based Exercise Intervention

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown Lombardi Office of Minority Health community site

Washington D.C., District of Columbia, 20003, United States

Location

Related Publications (2)

  • Adams-Campbell LL, Taylor T, Hicks J, Lu J, Dash C. The Effect of a 6-Month Exercise Intervention Trial on Allostatic Load in Black Women at Increased Risk for Breast Cancer: the FIERCE Study. J Racial Ethn Health Disparities. 2022 Oct;9(5):2063-2069. doi: 10.1007/s40615-021-01145-x. Epub 2021 Sep 27.

    PMID: 34580826DERIVED

  • Dash C, Makambi K, Wallington SF, Sheppard V, Taylor TR, Hicks JS, Adams-Campbell LL. An exercise trial targeting African-American women with metabolic syndrome and at high risk for breast cancer: Rationale, design, and methods. Contemp Clin Trials. 2015 Jul;43:33-8. doi: 10.1016/j.cct.2015.04.015. Epub 2015 May 8.

    PMID: 25962889DERIVED

MeSH Terms

Conditions

Metabolic SyndromeObesityBreast Neoplasms

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2014

First Posted

April 3, 2014

Study Start

January 1, 2012

Primary Completion

September 1, 2023

Study Completion

December 1, 2025

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations

US(1)