Using Grassroots Wellness Coaching to Enhance Reach and Sustainability of Behavioral Weight Management-Phase I
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Feasibility: Delivery Model
研究概览
简要总结
African American adults that live in economically disadvantaged areas are at an increased risk for obesity and cardiometabolic disease. The program being tested in this research study aims to address these factors and increase outcomes for the study population. The purpose of this research study is to find out about the feasibility and acceptability of using house chats (HC) as a model for delivering a weight-management program in a real-world, community-based setting.
详细描述
Wellness Ambassadors will undergo training to recruit and deliver a lifestyle intervention to members of their social networks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Investigator, Outcomes Assessor)
盲法说明
Single arm for Phase I
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 and older
- •Resident of Petersburg, VA
- •Interested in engaging community members in healthy lifestyle changes (e.g., walking, small changes to eating) and willing to engage in these behaviors her/himself
排除标准
- •A diagnosis of type 1 diabetes mellitus.
- •Currently being treated for cancer.
- •Medical conditions that may increase risk for participating in unsupervised exercise, if medical clearance is not provided
- •Hospitalization for depression or other psychiatric disorder within the past 12 months.
- •Lifetime history of bipolar disorder or psychotic disorder.
- •Currently pregnant or lactating, or planning to become pregnant within the study period.
- •Current involvement in a weight loss program or current use of weight loss medication.
- •Inability to speak, read and write English.
- •Planning to move from the Petersburg area within the study period.
- •Does not have sufficient numbers of individuals in their social network from which to recruit for the proposed study.
研究组 & 干预措施
Intervention
Wellness Ambassadors will undergo training to recruit and deliver a lifestyle intervention to members of their social networks. HCL in the intervention group will deliver the intervention immediately following baseline visits and randomization.
干预措施: Wellness Engagement Intervention (Behavioral)
结局指标
主要结局
Feasibility: Delivery Model
时间窗: 12 weeks
The number of intervention sessions delivered as planned. The pre-specified threshold was 70% of sessions.
Feasibility: House Chat Leaders (HCL)
时间窗: 18 months
House Chat Leaders (HCL) will undergo training to recruit and deliver a lifestyle intervention to members of their social networks.
Feasibility: Participants
时间窗: 18 months
The total number of participants recruited by the HCLs. The pre-specified goal is 80 participants overall (approximately 8 per house chat). A total of 71 individuals were interested and completed initial pre-screening. Of those, 43 were eligible and consented to participate. One individual did not complete their baseline visit, leaving 42 participants randomization eligible.
次要结局
- Acceptability: Attendance(12 weeks)
- Acceptability: Retention(12 weeks)