Evaluating the Fade to Fitness Program: A Barbershop-based Program for Black Men

Health Related Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06262334
• Other study ID #: Pro00133917
• Secondary ID: K23MD016123
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: June 15, 2024

Study information

• Verified date: March 2024
• Source: University of South Carolina
• Contact: Guillermo M Wippold, PhD
• Phone: 803-216-1051
• Email: wippold[@]mailbox.sc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Related Quality of Life

Intervention

Behavioral:
• The Fade to Fitness Program
The Fade to Fitness Program is a group-based and barbershop-based behavioral intervention to improve health-related quality of life among African American men. The program is unique because it is culturally targeted and individually tailored. The culturally targeted content was developed following barbershop-based focus groups. The Fade to Fitness Program targets four behaviors strongly linked to health-related quality of life among African American men - physical activity, healthy eating, stress management, and depression management. During the group-based portion of the program, Motivational Interviewing is used by the facilitator as a conversational approach to enhance participants' motivation and commitment towards positive behavior change. The goal is to foster intrinsic motivation among participants to engage in these behaviors. It is individually tailored by encouraging participants to identify personal values and linking them to health promoting behaviors.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of South Carolina	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of men who are eligible/eligible.	An excel sheet will be used to track the number of men who express interest in the study and are eligible/ineligible.	Up to 1 week
Primary	Length of time needed to enroll 15 men	An excel sheet will be used to track length of time needed to enroll 15 men.	Up to 1 week
Primary	Facilitator-assessed attendance in intervention	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).	Up to 1 week
Primary	Number of men who express interest in the study		Up to 1 week
Primary	Attrition in intervention	The excel sheet used to assess attendance will be used to assess attrition.	Baseline to 5 months
Primary	Acceptability, appropriateness, demand, implementation, practicality, and integration of the intervention	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.	2 months
Secondary	Change in weight		Change from baseline to 5 months
Secondary	Change in body mass index		Change from baseline to 5 months
Secondary	Change in moderate-to-vigorous physical activity	Average minutes of moderate-to-vigorous physical activity measured over 5 consecutive days using an accelerometer	Baseline to 5 months
Secondary	Global Health - Mental 2a	2-item measure of mental health; range: 2 - 10 with higher scores indicating better mental health.	Baseline to 5 months
Secondary	Global Health - Physical 2a	2-item measure of physical health; range: 2 - 10 with higher scores indicating better physical health.	Baseline to 5 months
Secondary	Perceived Stress Scale	10-item measure of perceived stress; range: 0 - 40 with higher scores indicating more perceived stress.	Baseline to 5 months
Secondary	Emotional Distress - Depression - Short Form 4a	4-item measure of depression; range: 4 - 20 with higher scores indicating more depressive symptoms.	Baseline to 5 months
Secondary	Healthy Eating Subscale of the Health Promotion Lifestyle Profile II	9-item measure of healthy eating; range: 9 - 36 with higher scores indicating greater engagement in healthy eating.	Baseline to 5 months
Secondary	Instrumental Support- Short Form 4a	4-item measure of instrumental support; range: 4 - 20 with higher scores indicating more instrumental support.	Baseline to 5 months
Secondary	Informational Support - Short Form 4a	4-item measure of informational support; range: 4 - 20 with higher scores indicating more informational support.	Baseline to 5 months
Secondary	Emotional Support - Short Form 4a	4-item measure of emotional support; range: 4 - 20 with higher scores indicating more emotional support.	Baseline to 5 months
Secondary	Companionship - Short Form 4a	4-item measure of companionship; range: 4 - 20 with higher scores indicating more companionship.	Baseline to 5 months
Secondary	Motivation and Attitudes Towards Changing Health (MATCH)	9-item measure of health motivation; range: 9 - 45 with higher scores indicating greater health motivation.	Baseline to 5 months
Secondary	NIH Self-Efficacy Measure	10-item measure of health self-efficacy; range: 10 - 50 with higher scores indicating greater health self-efficacy.	Baseline to 5 months
Secondary	Subjective Social Norms of Health Behavior	4-item measure using a researcher-developed subjective social norms measure to engage in health behaviors; range: 4 - 28 with higher scores indicating fewer social norms to engage in health behaviors.	Baseline to 5 months
Secondary	Valuing Questionnaire	10-item measure to assess values-based behavior; range: 0 - 60 with higher scores indicating more values-based behaviors.	Baseline to 5 months
Secondary	Diet	Measure using the Dietary Screener Questionnaire (variable length). This measure assess amount of dietary intake of fruits, vegetables, fiber, added sugars, calcium, dairy, and whole grains. A higher response indicates more intake of fruits, vegetables, fiber, added sugars, calcium, dairy, and whole grains.	Baseline to 5 months