A Resistance Training Program for Black Women: Project F.I.R.E.

This study will utilize a randomized control trial design, with participants randomly assigned to a theoretically-based culturally tailored intervention or standard of care group. Baseline (Week 0), 12-week, and 3-month follow-up (Week 24). Body composition and adherence will be tracked throughout the study. The exercise intervention will include a total body resistance training protocol and will take place at local fitness center. Participants will be randomized to either the theoretical-based culturally tailored intervention group or the standard exercise group in which each will be facilitated and supervised by a Black-trained research personnel following culturally tailored recommendations. All participants will attend a 10-week resistance training program twice per week for a total of 20 sessions from Weeks 2-11. Week 1 will be used to familiarize the participants with the resistance training exercises. Those randomized to the culturally tailored intervention group will receive health education, weekly text messages and self-regulatory strategies to overcome barriers to exercise. Participants will return for post testing at weeks 12 and 24.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Exercise

Detailed Description

This study will utilize a randomized control trial design, with participants randomly assigned to a theoretically-based culturally tailored intervention or standard of care group. Baseline (Week 0), 12-week, and 3-month follow-up (Week 24). Body composition and adherence will be tracked throughout the study. The exercise intervention will include a total body resistance training protocol and will take place at local fitness center. Participants will be randomized to either the theoretical-based culturally tailored intervention group or the standard exercise group in which each will be facilitated and supervised by a Black-trained research personnel following culturally tailored recommendations. All participants will attend a 10-week resistance training program twice per week for a total of 20 sessions from Weeks 2-11. Week 1 will be used to familiarize the participants with the resistance training exercises. Those randomized to the culturally tailored intervention group will receive health education, weekly text messages and self-regulatory strategies to overcome barriers to exercise. Participants will return for post testing at weeks 12 and 24.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danielle D Wadsworth, Ph.D.; Phone Number: 3348441836; Email: wadswdd@auburn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 18 and 34 years
• Identify as a black female
• Not actively participating in some type of exercise on a regular basis (at least three days a week for the past three months)
• Low risk for medical complications from exercise (as determined by the PAR-Q),
• Not pregnant or planning to become pregnant throughout the duration of the study
• Must live, work, or be a student in the city of Auburn, AL

Exclusion Criteria:

• women over 35
• Women who do not identify as black
• Regular exercisers,
• Pregnant women
• Women who do not have residency within Auburn AL

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Culturally Tailored; 10 weeks of resistance training utilizing culturally tailored prompts, feedback and high autonomy approaches.	Behavioral: Exercise; 10 weeks of resistance training.
Experimental: Control; 10 weeks of resistance training	Behavioral: Exercise; 10 weeks of resistance training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Composition	Changes in body fat percentage assessed by dual x-ray absorptiometry	12 weeks
Body Composition	Changes in body fat percentage assessed by dual x-ray absorptiometry	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to resistance training	The number of days resistance training is completed each week.	12 weeks
Adherence to resistance training	The number of days resistance training is completed each week.	24 weeks

Collaborators and Investigators

• Sponsor: Auburn University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 16, 2022
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 22-492 FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No