Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women

Overweight or Obesity Clinical Trial

— OVERCOME-IT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06360536
• Other study ID #: IRB-300012634
• Secondary ID: P50MD017338
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2024
• Source: University of Alabama at Birmingham
• Contact: Jackie Grant
• Phone: 205-975-7108
• Email: jroche[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Overweight
• Overweight or Obesity
• Prehypertension
• Resistance Training

Intervention

Behavioral:
• Resistance Training
A home-based resistance training condition that is delivered through a web-based platform.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment	The number of participants enrolled in the trial	Baseline
Primary	Feasibility of retention	The proportion of participants who complete the study out of those who enrolled in the study	Month 4
Primary	Intervention adherence	The number of participants adhering to the intervention	Month 4
Secondary	Change in resistance training behaviors	The number of days of resistance training completed	Baseline and Month 4
Secondary	Change in blood pressure	Systolic and diastolic blood pressure measured by an automated device	Baseline, Month 4
Secondary	Change in HbA1C	HbA1C measured by a point-of-care device	Baseline, Month 4
Secondary	Change in body composition	Percent body fat measured by dual-energy x-ray absorptiometry	Baseline, Month 4
Secondary	Change in handgrip strength	The highest value of 3 maximal attempts on each hand	Baseline, Month 4
Secondary	Change in the number of chair stands	The number of chair stands completed in 30 seconds	Baseline, Month 4