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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05733260
• Other study ID #: 22-492 FB
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2023
• Source: Auburn University
• Contact: Danielle D Wadsworth, Ph.D.
• Phone: 3348441836
• Email: wadswdd[@]auburn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 1, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Exercise
10 weeks of resistance training.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Auburn University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Composition	Changes in body fat percentage assessed by dual x-ray absorptiometry	12 weeks
Primary	Body Composition	Changes in body fat percentage assessed by dual x-ray absorptiometry	24 weeks
Secondary	Adherence to resistance training	The number of days resistance training is completed each week.	12 weeks
Secondary	Adherence to resistance training	The number of days resistance training is completed each week.	24 weeks