Skip to main content
Clinical Trials/NCT06262334
NCT06262334
Recruiting
Not Applicable

Developing a Community-Informed, Peer-to-Peer Intervention to Improve Health-Related Quality of Life Among African American Men

University of South Carolina1 site in 1 country15 target enrollmentMarch 6, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Health Related Quality of Life
Sponsor
University of South Carolina
Enrollment
15
Locations
1
Primary Endpoint
Number of men who express interest in the study
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The Fade to Fitness Program is a targeted intervention designed to improve the holistic health and quality of life among Black men. This comprehensive initiative focuses on four key health behaviors: Physical Activity, Healthy Eating, Stress Management, and Depression Management.

It is grounded in psychological and social theories like Self-Determination Theory, Motivational Interviewing, and Social Cognitive Theory. The program emphasizes the importance of making informed choices, feeling competent and connected, and learning through observation and modeling. Facilitators play a pivotal role, leading group discussions, providing support, and fostering an inclusive atmosphere.

The program is structured into weekly sessions that tackle each health behavior, interspersed with off weeks; for community engagement, especially in barbershops, to discuss health topics and promote a healthier lifestyle.

Registry
clinicaltrials.gov
Start Date
March 6, 2024
End Date
July 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Guillermo Wippold

Associate Professor

University of South Carolina

Eligibility Criteria

Inclusion Criteria

  • Self-identify as African American or Black American male - 18 - 90 years of age
  • Able to speak and understand English

Exclusion Criteria

  • Currently participating in another health promotion intervention
  • On a special diet for a serious health condition
  • Intending to move within 6 months of participating in the intervention

Outcomes

Primary Outcomes

Number of men who express interest in the study

Time Frame: Up to 1 week

Length of time needed to enroll 15 men

Time Frame: Up to 1 week

An excel sheet will be used to track length of time needed to enroll 15 men.

Facilitator-assessed attendance in intervention

Time Frame: Up to 1 week

An excel sheet will be used to track each participant's attendance. Participants attendance will be entered as 1 (attended) or 0 (did not attend).

Attrition in intervention

Time Frame: Baseline to 5 months

The excel sheet used to assess attendance will be used to assess attrition.

Number of men who are eligible/eligible.

Time Frame: Up to 1 week

An excel sheet will be used to track the number of men who express interest in the study and are eligible/ineligible.

Acceptability, appropriateness, demand, implementation, practicality, and integration of the intervention

Time Frame: 2 months

Qualitative data will be collected based on guidelines created by research funded by the National Cancer Institute to understand the feasibility of health promotion interventions among underserved populations. The interview questions will assess the acceptability (e.g., satisfaction, perceived appropriateness, fit with cultural structure), demand (e.g., intent to use, actual use, expressed interest or intention to use), implementation (e.g., degree of execution), practicality (e.g., amount of time needed, quality of implementation, ability to carry out intervention activities), and integration (e.g., perceived sustainability) of the intervention.

Secondary Outcomes

  • Change in weight(Change from baseline to 5 months)
  • Subjective Social Norms of Health Behavior(Baseline to 5 months)
  • Change in body mass index(Change from baseline to 5 months)
  • Emotional Distress - Depression - Short Form 4a(Baseline to 5 months)
  • Instrumental Support- Short Form 4a(Baseline to 5 months)
  • Informational Support - Short Form 4a(Baseline to 5 months)
  • Emotional Support - Short Form 4a(Baseline to 5 months)
  • Companionship - Short Form 4a(Baseline to 5 months)
  • Motivation and Attitudes Towards Changing Health (MATCH)(Baseline to 5 months)
  • NIH Self-Efficacy Measure(Baseline to 5 months)
  • Change in moderate-to-vigorous physical activity(Baseline to 5 months)
  • Global Health - Mental 2a(Baseline to 5 months)
  • Global Health - Physical 2a(Baseline to 5 months)
  • Perceived Stress Scale(Baseline to 5 months)
  • Healthy Eating Subscale of the Health Promotion Lifestyle Profile II(Baseline to 5 months)
  • Valuing Questionnaire(Baseline to 5 months)
  • Diet(Baseline to 5 months)

Study Sites (1)

Loading locations...

Similar Trials