- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06262334
Evaluating the Fade to Fitness Program: a Barbershop-based Program for Black Men
Developing a Community-Informed, Peer-to-Peer Intervention to Improve Health-Related Quality of Life Among African American Men
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Guillermo M Wippold, PhD
- Phone Number: 803-216-1051
- Email: wippold@mailbox.sc.edu
Study Locations
-
-
South Carolina
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Columbia, South Carolina, United States, 29208
- Recruiting
- University of South Carolina
-
Contact:
- Guillermo M Wippold, PhD
- Phone Number: 803-216-1051
- Email: wippold@mailbox.sc.edu
-
Contact:
- Guillermo M Wippold, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
Up to 1 week
|
|
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).
|
Up to 1 week
|
|
Number of men who express interest in the study
Time Frame: Up to 1 week
|
Up to 1 week
|
|
|
Attrition in intervention
Time Frame: Baseline to 5 months
|
The excel sheet used to assess attendance will be used to assess attrition.
|
Baseline to 5 months
|
|
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.
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in weight
Time Frame: Change from baseline to 5 months
|
Change from baseline to 5 months
|
|
|
Change in body mass index
Time Frame: Change from baseline to 5 months
|
Change from baseline to 5 months
|
|
|
Change in moderate-to-vigorous physical activity
Time Frame: Baseline to 5 months
|
Average minutes of moderate-to-vigorous physical activity measured over 5 consecutive days using an accelerometer
|
Baseline to 5 months
|
|
Global Health - Mental 2a
Time Frame: Baseline to 5 months
|
2-item measure of mental health; range: 2 - 10 with higher scores indicating better mental health.
|
Baseline to 5 months
|
|
Global Health - Physical 2a
Time Frame: Baseline to 5 months
|
2-item measure of physical health; range: 2 - 10 with higher scores indicating better physical health.
|
Baseline to 5 months
|
|
Perceived Stress Scale
Time Frame: Baseline to 5 months
|
10-item measure of perceived stress; range: 0 - 40 with higher scores indicating more perceived stress.
|
Baseline to 5 months
|
|
Emotional Distress - Depression - Short Form 4a
Time Frame: Baseline to 5 months
|
4-item measure of depression; range: 4 - 20 with higher scores indicating more depressive symptoms.
|
Baseline to 5 months
|
|
Healthy Eating Subscale of the Health Promotion Lifestyle Profile II
Time Frame: Baseline to 5 months
|
9-item measure of healthy eating; range: 9 - 36 with higher scores indicating greater engagement in healthy eating.
|
Baseline to 5 months
|
|
Instrumental Support- Short Form 4a
Time Frame: Baseline to 5 months
|
4-item measure of instrumental support; range: 4 - 20 with higher scores indicating more instrumental support.
|
Baseline to 5 months
|
|
Informational Support - Short Form 4a
Time Frame: Baseline to 5 months
|
4-item measure of informational support; range: 4 - 20 with higher scores indicating more informational support.
|
Baseline to 5 months
|
|
Emotional Support - Short Form 4a
Time Frame: Baseline to 5 months
|
4-item measure of emotional support; range: 4 - 20 with higher scores indicating more emotional support.
|
Baseline to 5 months
|
|
Companionship - Short Form 4a
Time Frame: Baseline to 5 months
|
4-item measure of companionship; range: 4 - 20 with higher scores indicating more companionship.
|
Baseline to 5 months
|
|
Motivation and Attitudes Towards Changing Health (MATCH)
Time Frame: Baseline to 5 months
|
9-item measure of health motivation; range: 9 - 45 with higher scores indicating greater health motivation.
|
Baseline to 5 months
|
|
NIH Self-Efficacy Measure
Time Frame: Baseline to 5 months
|
10-item measure of health self-efficacy; range: 10 - 50 with higher scores indicating greater health self-efficacy.
|
Baseline to 5 months
|
|
Subjective Social Norms of Health Behavior
Time Frame: Baseline to 5 months
|
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
|
|
Valuing Questionnaire
Time Frame: Baseline to 5 months
|
10-item measure to assess values-based behavior; range: 0 - 60 with higher scores indicating more values-based behaviors.
|
Baseline to 5 months
|
|
Diet
Time Frame: Baseline to 5 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guillermo M Wippold, University of South Carolina
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro00133917
- K23MD016123 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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