NCT06262334

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

March 6, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

February 19, 2025

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

January 17, 2024

Last Update Submit

February 14, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • Number of men who express interest in the study

    Up to 1 week

  • Attrition in intervention

    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

    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 Outcomes (17)

  • Change in weight

    Change from baseline to 5 months

  • Change in body mass index

    Change from 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

  • +12 more secondary outcomes

Study Arms (1)

The Fade to Fitness Program

EXPERIMENTAL
Behavioral: The Fade to Fitness Program

Interventions

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.

The Fade to Fitness Program

Eligibility Criteria

Age18 Years - 90 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsIndividuals must identify as male regardless of biological sex.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

RECRUITING

Study Officials

  • Guillermo M Wippold

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillermo M Wippold, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 17, 2024

First Posted

February 16, 2024

Study Start

March 6, 2024

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

February 19, 2025

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Data can be shared upon reasonable request.

More information

Locations