Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women (OVERCOME-IT)

Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women: A Pilot Trial

The purpose of this study is to collect preliminary data on the feasibility, acceptability, and potential effects of a novel, remotely delivered resistance training program.

Study Overview

• Status: Active, not recruiting
• Conditions: Overweight or Obesity; Resistance Training; Prediabetes or Diabetes; Prehypertension (Elevated Blood Pressure) or Hypertension
• Intervention / Treatment: Behavioral: Resistance Training

Detailed Description

This trial will enroll Black women with elevated cardiometabolic risk (e.g., overweight or obesity, pre- or established diabetes, and elevated or high blood pressure) in early-to-middle adulthood (n=36; age=30-64 years) with insufficient resistance training (RT) participation. This 4-month single group pilot trial evaluates the feasibility, acceptability, and potential effects of a novel, remotely-delivered resistance training (RT) intervention. All participants will engage in RT during this trial and the web-based platform is the primary modality through which the remote RT intervention is delivered. Assessments are conducted at baseline and follow-up (month 4). Aim 1 will examine the feasibility and acceptability of the remotely delivered RT program. Aim 2 will examine the potential effects on RT behaviors. Aim 3 will examine the potential effects on clinical and patient-reported outcomes.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Self-identifies as Black or African American
• Female
• Age 30-64 years
• Insufficient resistance training engagement (<2 sessions/week in the past 6 months)

AND

• Self-reported or documented diagnosis of at least one of the following conditions: Overweight, obesity, prediabetes, type 2 diabetes, elevated blood pressure, hypertension, or taking medications for any of these conditions
• Has an internet- connected device (i.e., computer, smartphone) and is willing to use it for intervention delivery
• If indicated during screening, willing to obtain medical clearance for exercise from their healthcare provider prior to enrollment
• Residing within a 50-mile radius of the University

Exclusion Criteria:

• Uncontrolled hypertension (blood pressure >160/100 mm Hg)
• Weighing ≥ 450 lbs (upper limit for body composition assessment)
• Conditions or limitations that affect physical activity participation and/or the ability to --perform assessments
• Has a medical or physical condition that make moderate intensity physical activity (like a brisk walk) difficult or unsafe
• Unwilling to obtain medical clearance (if indicated by prescreening)
• Women who are pregnant or trying to become pregnant in the next 6 months
• Planning to relocate out of the area in the next 6 months
• Participating in another exercise and/or randomized research project
• Unwilling or unable to do any of the following: give informed consent; read/understand English; perform resistance training in their home, record and upload virtual exercise assessment sessions, and other protocol specific requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention/Treatment; A home-based resistance training condition that is delivered through a web-based platform.	Behavioral: Resistance Training; A home-based resistance training condition that is delivered through a web-based platform.; Other Names: RT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment	The number of participants enrolled in the trial	Baseline
Feasibility of retention	The proportion of participants who complete the study out of those who enrolled in the study	Month 4
Intervention adherence	The number of participants adhering to the intervention	Month 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in resistance training behaviors	The number of days of resistance training completed	Baseline and Month 4
Change in blood pressure	Systolic and diastolic blood pressure measured by an automated device	Baseline, Month 4
Change in HbA1C	HbA1C measured by a point-of-care device	Baseline, Month 4
Change in body composition	Percent body fat measured by dual-energy x-ray absorptiometry	Baseline, Month 4
Change in handgrip strength	The highest value of 3 maximal attempts on each hand	Baseline, Month 4
Change in the number of chair stands	The number of chair stands completed in 30 seconds	Baseline, Month 4

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Amber W Kinsey, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Hypertension; Diabetes Mellitus; Prediabetic State; Prehypertension; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Physical Conditioning, Human; Exercise; Resistance Training
• Other Study ID Numbers: IRB-300012634; P50MD017338 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No