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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Sarahi Hernandez, MPH
- Phone Number: 205-996-1638
- Email: sarahihernandez@uabmc.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Intervention/Treatment
A home-based resistance training condition that is delivered through a web-based platform.
|
A home-based resistance training condition that is delivered through a web-based platform.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of recruitment
Time Frame: Baseline
|
The number of participants enrolled in the trial
|
Baseline
|
|
Feasibility of retention
Time Frame: Month 4
|
The proportion of participants who complete the study out of those who enrolled in the study
|
Month 4
|
|
Intervention adherence
Time Frame: Month 4
|
The number of participants adhering to the intervention
|
Month 4
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in resistance training behaviors
Time Frame: Baseline and Month 4
|
The number of days of resistance training completed
|
Baseline and Month 4
|
|
Change in blood pressure
Time Frame: Baseline, Month 4
|
Systolic and diastolic blood pressure measured by an automated device
|
Baseline, Month 4
|
|
Change in HbA1C
Time Frame: Baseline, Month 4
|
HbA1C measured by a point-of-care device
|
Baseline, Month 4
|
|
Change in body composition
Time Frame: Baseline, Month 4
|
Percent body fat measured by dual-energy x-ray absorptiometry
|
Baseline, Month 4
|
|
Change in handgrip strength
Time Frame: Baseline, Month 4
|
The highest value of 3 maximal attempts on each hand
|
Baseline, Month 4
|
|
Change in the number of chair stands
Time Frame: Baseline, Month 4
|
The number of chair stands completed in 30 seconds
|
Baseline, Month 4
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Amber W Kinsey, PhD, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
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
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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