Clinical trial NCT06360536: Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women
Official title: Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight or Obesity
Prediabetes or Diabetes
Prehypertension (Elevated Blood Pressure) or Hypertension
Resistance Training
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-04-11
Enrollment: 36
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: Baseline
measure: Feasibility of retention
timeFrame: Month 4
measure: Intervention adherence
timeFrame: Month 4
Secondary outcomes:
measure: Change in resistance training behaviors
timeFrame: Baseline and Month 4
measure: Change in blood pressure
timeFrame: Baseline, Month 4
measure: Change in HbA1C
timeFrame: Baseline, Month 4
measure: Change in body composition
timeFrame: Baseline, Month 4
measure: Change in handgrip strength
timeFrame: Baseline, Month 4
measure: Change in the number of chair stands
timeFrame: Baseline, Month 4
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Amber W Kinsey, PhD
role: PRINCIPAL_INVESTIGATOR
References: