Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-29 @ 5:51 AM
Study NCT ID:
NCT06262334
Status:
RECRUITING
Last Update Posted:
2025-02-19
First Post:
2024-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Fade to Fitness Program: A Barbershop-based Program for Black Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2024-01-17', 'studyFirstSubmitQcDate': '2024-02-14', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of men who are eligible/eligible.', 'timeFrame': 'Up to 1 week', 'description': 'An excel sheet will be used to track the number of men who express interest in the study and are eligible/ineligible.'}, {'measure': 'Length of time needed to enroll 15 men', 'timeFrame': 'Up to 1 week', 'description': 'An excel sheet will be used to track length of time needed to enroll 15 men.'}, {'measure': 'Facilitator-assessed attendance in intervention', 'timeFrame': 'Up to 1 week', 'description': "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)."}, {'measure': 'Number of men who express interest in the study', 'timeFrame': 'Up to 1 week'}, {'measure': 'Attrition in intervention', 'timeFrame': 'Baseline to 5 months', 'description': 'The excel sheet used to assess attendance will be used to assess attrition.'}, {'measure': 'Acceptability, appropriateness, demand, implementation, practicality, and integration of the intervention', 'timeFrame': '2 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in weight', 'timeFrame': 'Change from baseline to 5 months'}, {'measure': 'Change in body mass index', 'timeFrame': 'Change from baseline to 5 months'}, {'measure': 'Change in moderate-to-vigorous physical activity', 'timeFrame': 'Baseline to 5 months', 'description': 'Average minutes of moderate-to-vigorous physical activity measured over 5 consecutive days using an accelerometer'}, {'measure': 'Global Health - Mental 2a', 'timeFrame': 'Baseline to 5 months', 'description': '2-item measure of mental health; range: 2 - 10 with higher scores indicating better mental health.'}, {'measure': 'Global Health - Physical 2a', 'timeFrame': 'Baseline to 5 months', 'description': '2-item measure of physical health; range: 2 - 10 with higher scores indicating better physical health.'}, {'measure': 'Perceived Stress Scale', 'timeFrame': 'Baseline to 5 months', 'description': '10-item measure of perceived stress; range: 0 - 40 with higher scores indicating more perceived stress.'}, {'measure': 'Emotional Distress - Depression - Short Form 4a', 'timeFrame': 'Baseline to 5 months', 'description': '4-item measure of depression; range: 4 - 20 with higher scores indicating more depressive symptoms.'}, {'measure': 'Healthy Eating Subscale of the Health Promotion Lifestyle Profile II', 'timeFrame': 'Baseline to 5 months', 'description': '9-item measure of healthy eating; range: 9 - 36 with higher scores indicating greater engagement in healthy eating.'}, {'measure': 'Instrumental Support- Short Form 4a', 'timeFrame': 'Baseline to 5 months', 'description': '4-item measure of instrumental support; range: 4 - 20 with higher scores indicating more instrumental support.'}, {'measure': 'Informational Support - Short Form 4a', 'timeFrame': 'Baseline to 5 months', 'description': '4-item measure of informational support; range: 4 - 20 with higher scores indicating more informational support.'}, {'measure': 'Emotional Support - Short Form 4a', 'timeFrame': 'Baseline to 5 months', 'description': '4-item measure of emotional support; range: 4 - 20 with higher scores indicating more emotional support.'}, {'measure': 'Companionship - Short Form 4a', 'timeFrame': 'Baseline to 5 months', 'description': '4-item measure of companionship; range: 4 - 20 with higher scores indicating more companionship.'}, {'measure': 'Motivation and Attitudes Towards Changing Health (MATCH)', 'timeFrame': 'Baseline to 5 months', 'description': '9-item measure of health motivation; range: 9 - 45 with higher scores indicating greater health motivation.'}, {'measure': 'NIH Self-Efficacy Measure', 'timeFrame': 'Baseline to 5 months', 'description': '10-item measure of health self-efficacy; range: 10 - 50 with higher scores indicating greater health self-efficacy.'}, {'measure': 'Subjective Social Norms of Health Behavior', 'timeFrame': 'Baseline to 5 months', 'description': '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.'}, {'measure': 'Valuing Questionnaire', 'timeFrame': 'Baseline to 5 months', 'description': '10-item measure to assess values-based behavior; range: 0 - 60 with higher scores indicating more values-based behaviors.'}, {'measure': 'Diet', 'timeFrame': 'Baseline to 5 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Related Quality of Life']}, 'descriptionModule': {'briefSummary': '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.\n\nIt 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Individuals must identify as male regardless of biological sex.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-identify as African American or Black American male - 18 - 90 years of age\n* Able to speak and understand English\n\nExclusion Criteria:\n\n* Currently participating in another health promotion intervention\n* On a special diet for a serious health condition\n* Intending to move within 6 months of participating in the intervention'}, 'identificationModule': {'nctId': 'NCT06262334', 'briefTitle': 'Evaluating the Fade to Fitness Program: A Barbershop-based Program for Black Men', 'organization': {'class': 'OTHER', 'fullName': 'University of South Carolina'}, 'officialTitle': 'Developing a Community-Informed, Peer-to-Peer Intervention to Improve Health-Related Quality of Life Among African American Men', 'orgStudyIdInfo': {'id': 'Pro00133917'}, 'secondaryIdInfos': [{'id': 'K23MD016123', 'link': 'https://reporter.nih.gov/quickSearch/K23MD016123', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The Fade to Fitness Program', 'interventionNames': ['Behavioral: The Fade to Fitness Program']}], 'interventions': [{'name': 'The Fade to Fitness Program', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['The Fade to Fitness Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29208', 'city': 'Columbia', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Guillermo M Wippold, PhD', 'role': 'CONTACT', 'email': 'wippold@mailbox.sc.edu', 'phone': '803-216-1051'}, {'name': 'Guillermo M Wippold, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of South Carolina', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}], 'centralContacts': [{'name': 'Guillermo M Wippold, PhD', 'role': 'CONTACT', 'email': 'wippold@mailbox.sc.edu', 'phone': '803-216-1051'}], 'overallOfficials': [{'name': 'Guillermo M Wippold', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Carolina'}]}, 'ipdSharingStatementModule': {'url': 'https://www.sc.edu', 'ipdSharing': 'YES', 'description': 'Data can be shared upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Guillermo Wippold', 'investigatorAffiliation': 'University of South Carolina'}}}}