NCT05733260

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable obesity

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

December 16, 2022

Last Update Submit

March 2, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Adherence to resistance training

    12 weeks

  • Adherence to resistance training

    24 weeks

Study Arms (2)

Culturally Tailored

EXPERIMENTAL

10 weeks of resistance training utilizing culturally tailored prompts, feedback and high autonomy approaches.

Behavioral: Exercise

Control

EXPERIMENTAL

10 weeks of resistance training

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

10 weeks of resistance training.

ControlCulturally Tailored

Eligibility Criteria

Age18 Years - 34 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Danielle D Wadsworth, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 16, 2022

First Posted

February 17, 2023

Study Start

March 1, 2023

Primary Completion

August 31, 2023

Study Completion

December 1, 2023

Last Updated

March 6, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share