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临床试验/NCT06262334
NCT06262334Unknown不适用

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

University of South Carolina1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年3月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
15
试验地点
1
主要终点
Length of time needed to enroll 15 men

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

The Fade to Fitness Program

Experimental

干预措施: The Fade to Fitness Program (Behavioral)

结局指标

主要结局

Length of time needed to enroll 15 men

时间窗: Up to 1 week

An excel sheet will be used to track length of time needed to enroll 15 men.

Number of men who express interest in the study

时间窗: Up to 1 week

Facilitator-assessed attendance in intervention

时间窗: 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).

Attrition in intervention

时间窗: Baseline to 5 months

The excel sheet used to assess attendance will be used to assess attrition.

Number of men who are eligible/eligible.

时间窗: 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.

Acceptability, appropriateness, demand, implementation, practicality, and integration of the intervention

时间窗: 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.

次要结局

  • Change in moderate-to-vigorous physical activity(Baseline to 5 months)
  • Valuing Questionnaire(Baseline to 5 months)
  • Change in weight(Change from baseline to 5 months)
  • Subjective Social Norms of Health Behavior(Baseline to 5 months)
  • NIH Self-Efficacy Measure(Baseline to 5 months)
  • Change in body mass index(Change from baseline to 5 months)
  • Emotional Distress - Depression - Short Form 4a(Baseline to 5 months)
  • Instrumental Support- Short Form 4a(Baseline to 5 months)
  • Informational Support - Short Form 4a(Baseline to 5 months)
  • Emotional Support - Short Form 4a(Baseline to 5 months)
  • Companionship - Short Form 4a(Baseline to 5 months)
  • Motivation and Attitudes Towards Changing Health (MATCH)(Baseline to 5 months)
  • Global Health - Mental 2a(Baseline to 5 months)
  • Global Health - Physical 2a(Baseline to 5 months)
  • Perceived Stress Scale(Baseline to 5 months)
  • Healthy Eating Subscale of the Health Promotion Lifestyle Profile II(Baseline to 5 months)
  • Diet(Baseline to 5 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guillermo Wippold

Associate Professor

University of South Carolina

研究点 (1)

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