Overweight or Obesity, Prediabetes or Diabetes, Prehypertension (Elevated Blood Pressure) or Hypertension, Resistance Training
Conditions
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.
Interventions
BEHAVIORALResistance Training
A home-based resistance training condition that is delivered through a web-based platform.
Sponsors
University of Alabama at Birmingham
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of recruitment | Baseline | The number of participants enrolled in the trial |
| Feasibility of retention | Month 4 | The proportion of participants who complete the study out of those who enrolled in the study |
| Intervention adherence | Month 4 | The number of participants adhering to the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in resistance training behaviors | Baseline and Month 4 | The number of days of resistance training completed |
| Change in blood pressure | Baseline, Month 4 | Systolic and diastolic blood pressure measured by an automated device |
| Change in HbA1C | Baseline, Month 4 | HbA1C measured by a point-of-care device |
| Change in body composition | Baseline, Month 4 | Percent body fat measured by dual-energy x-ray absorptiometry |
| Change in handgrip strength | Baseline, Month 4 | The highest value of 3 maximal attempts on each hand |
| Change in the number of chair stands | Baseline, Month 4 | The number of chair stands completed in 30 seconds |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmber W Kinsey, PhD
University of Alabama at Birmingham
Outcome results
None listed