Health Related Quality of LifeNCT06262334
Evaluating the Fade to Fitness Program: A Barbershop-based Program for Black Men
A study testing The Fade to Fitness Program in people with Health Related Quality of Life, run by University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Health Related Quality of Life
- What is being tested?
- The Fade to Fitness Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identify as African American or Black American male - 18 - 90 years of age
- Able to speak and understand English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of South Carolina
Columbia, South Carolina, 29208
Guillermo M Wippold, PhD, 803-216-1051, wippold@mailbox.sc.edu
Guillermo M Wippold, PhD
About this study
Official title: 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.
- Conditions
- Health Related Quality of Life
- Being tested
- The Fade to Fitness Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Fade to Fitness ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The Fade to Fitness Program | Experimental | Not described Receives: Behavioral: The Fade to Fitness Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 week
Length of time needed to enroll 15 men
An excel sheet will be used to track length of time needed to enroll 15 men.
Measured: Up to 1 week
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).
Measured: Up to 1 week
Number of men who express interest in the study
Measured: Up to 1 week
Attrition in intervention
The excel sheet used to assess attendance will be used to assess attrition.
Measured: Baseline to 5 months
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.
Measured: 2 months
Secondary outcomes (17)
Change in weight
Measured: Change from baseline to 5 months
Change in body mass index
Measured: Change from baseline to 5 months
Change in moderate-to-vigorous physical activity
Average minutes of moderate-to-vigorous physical activity measured over 5 consecutive days using an accelerometer
Measured: Baseline to 5 months
Global Health - Mental 2a
2-item measure of mental health; range: 2 - 10 with higher scores indicating better mental health.
Measured: Baseline to 5 months
Global Health - Physical 2a
2-item measure of physical health; range: 2 - 10 with higher scores indicating better physical health.
Measured: Baseline to 5 months
Perceived Stress Scale
10-item measure of perceived stress; range: 0 - 40 with higher scores indicating more perceived stress.
Measured: Baseline to 5 months
Emotional Distress - Depression - Short Form 4a
4-item measure of depression; range: 4 - 20 with higher scores indicating more depressive symptoms.
Measured: Baseline to 5 months
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.
Measured: Baseline to 5 months
Instrumental Support- Short Form 4a
4-item measure of instrumental support; range: 4 - 20 with higher scores indicating more instrumental support.
Measured: Baseline to 5 months
Informational Support - Short Form 4a
4-item measure of informational support; range: 4 - 20 with higher scores indicating more informational support.
Measured: Baseline to 5 months
Emotional Support - Short Form 4a
4-item measure of emotional support; range: 4 - 20 with higher scores indicating more emotional support.
Measured: Baseline to 5 months
Companionship - Short Form 4a
4-item measure of companionship; range: 4 - 20 with higher scores indicating more companionship.
Measured: Baseline to 5 months
Motivation and Attitudes Towards Changing Health (MATCH)
9-item measure of health motivation; range: 9 - 45 with higher scores indicating greater health motivation.
Measured: Baseline to 5 months
NIH Self-Efficacy Measure
10-item measure of health self-efficacy; range: 10 - 50 with higher scores indicating greater health self-efficacy.
Measured: Baseline to 5 months
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.
Measured: Baseline to 5 months
Valuing Questionnaire
10-item measure to assess values-based behavior; range: 0 - 60 with higher scores indicating more values-based behaviors.
Measured: Baseline to 5 months
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.
Measured: Baseline to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start6 Mar 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Related Quality of LifeStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Guillermo Wippold, University of South Carolina
- Investigators
- Guillermo M Wippold, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262334
- Sponsor's protocol ID
- Pro00133917
- Other IDs
- K23MD016123
- Status last verified
- Mar 2024
- First submitted
- 17 Jan 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Community-Informed, Peer-to-Peer Intervention to Improve Health-Related Quality of Life Among African American Men
- ClinicalTrials.gov ID
- NCT06262334
- Acronym / sponsor ID
- Pro00133917
- Conditions
- Health Related Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Fade to Fitness Program | Experimental | Behavioral: The Fade to Fitness Program |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Self-identify as African American or Black American male - 18 - 90 years of age
- Able to speak and understand English
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Fade to Fitness ProgramThe 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. | Behavioural | The Fade to Fitness Program |
Primary outcome
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.
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).
Number of men who express interest in the study
Time frame: 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.
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.
17 secondary outcomes
Change in weight
Time frame: Change from baseline to 5 months
Change in body mass index
Time frame: Change from baseline to 5 months
Change in moderate-to-vigorous physical activity
Time frame: Baseline to 5 months
Global Health - Mental 2a
Time frame: Baseline to 5 months
Global Health - Physical 2a
Time frame: Baseline to 5 months
Perceived Stress Scale
Time frame: Baseline to 5 months
Emotional Distress - Depression - Short Form 4a
Time frame: Baseline to 5 months
Healthy Eating Subscale of the Health Promotion Lifestyle Profile II
Time frame: Baseline to 5 months
Instrumental Support- Short Form 4a
Time frame: Baseline to 5 months
Informational Support - Short Form 4a
Time frame: Baseline to 5 months
Emotional Support - Short Form 4a
Time frame: Baseline to 5 months
Companionship - Short Form 4a
Time frame: Baseline to 5 months
Motivation and Attitudes Towards Changing Health (MATCH)
Time frame: Baseline to 5 months
NIH Self-Efficacy Measure
Time frame: Baseline to 5 months
Subjective Social Norms of Health Behavior
Time frame: Baseline to 5 months
Valuing Questionnaire
Time frame: Baseline to 5 months
Diet
Time frame: Baseline to 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: Yes. Data can be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo M Wippold principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Fade to Fitness Program in people with Health Related Quality of Life, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillermo M Wippold, PhD (803-216-1051, wippold@mailbox.sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of men who are eligible/eligible. (time frame: Up to 1 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025; AzTrials last refreshed its copy on 2 Nov 2026.