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临床试验/NCT05473871
NCT05473871招募中不适用

Enhancing Capacity in Faith-based Organizations to Implement and Sustain Multilevel Innovations to Improve Physical Activity

San Diego State University1 个研究点 分布在 1 个国家目标入组 560 人开始时间: 2022年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
560
试验地点
1
主要终点
Individual Level: Change in Participants' Moderate to Vigorous Physical Activity (MVPA) from Baseline to Month 12

研究概览

简要总结

Despite the benefits of physical activity (PA) to prevent cardiovascular disease and other chronic diseases, few adult Latinas meet PA guidelines. Given the central role of churches within the Latino community and their commitment to the well-being of their members, they are ideal settings for health promotion. Evidence-based interventions (EBIs) for increasing PA and reducing obesity exist, but few PA interventions go to scale. Investigators propose to enhance Faith in Action with three organization-level strategies designed to increase program fit and effectiveness: 1) training church leaders in health promotion; 2) tailoring messaging to enhance fit between Faith in Action and each unique church environment; and 3) empowering community health workers (promotoras) to advocate for organizational change. Given the need to improve strategies to sustain health programs in community settings, investigators will test the influence of two additional sustainment strategies: 1) strengthening community collaborations and 2) providing technical support. Twenty-eight churches will be randomly assigned to a Standard EBI group (Faith in Action as originally implemented), an Enhanced group (Standard intervention + organizational-level implementation strategies), or an Enhanced + Sustainment group (Enhanced implementation group + sustainment strategies). Investigators will test the proposed implementation strategies on organization-level change and individual behavior in diverse churches for a 12-month intervention and 6-month follow-up period. The proposed study aims to: 1) Test the short and long-term impacts of organization-level implementation strategies in 2 Enhanced conditions on organizational outcomes compared to the Standard EBI condition and 2) Examine individual behavior change among Latinas (N=560) in churches in the 2 Enhanced conditions compared to the Standard EBI condition. The study's primary hypothesis is that Latina's receiving the Enhanced interventions will increase their PA levels significantly more than those receiving the Standard Faith in Action intervention, and the improvements in PA will be sustained. If successful, findings from the current study will provide evidence of organizational-level strategies for uptake, sustainment, and implementation strategies for scale-up of PA interventions to increase PA and reduce chronic disease in churches across the US.

详细描述

This study, guided by PRISM/RE-AIM frameworks, will use a pragmatic, cluster randomized controlled design to stratify by faith-based organization (FBO) size, and randomly assign 28 FBOs to one of 3 conditions: a Standard implementation condition (n=8 FBOs), an Enhanced implementation condition (Standard + organizational implementation strategies; n=10 FBOs), or an Enhanced + Sustainment condition (Enhanced + sustainment strategies; n=10 FBOs) for a 12-mo intervention with a 6-month sustainment follow- up period. This design offers the opportunity to examine the impact of explicit implementation and sustainment strategies compared to the Standard EBI condition to advance the science on scaling up EBIs. Investigators will allocate more churches in the Enhanced conditions to provide more opportunities to test the implementation process and impact of the proposed strategies in diverse church contexts. This design will allow investigators to examine the additive impact of the organization-level implementation strategies on both organizational outcomes (Aim 1) and individual outcomes (Aim 2). Investigators will examine the potential mechanisms of action (Secondary Aim 1) of the organizational implementation strategies. At 12 months post-baseline, FBOs in the Standard (n=8) and Enhanced condition (n=10) will receive no additional support while FBOs in the Enhanced + Sustainment condition (n=10) will receive additional program support (Secondary Aim 2) to examine the impact of sustainment strategies on both program and participant PA sustainment over an additional 6 months. Quantitative and qualitative data will be collected at baseline, 6 months, 12 months, and 18 months post baseline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Triple

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Self-identifying as Latina
  • Aged 18-65 years
  • Planning on attending the FBO for the next 18 months
  • Low self-reported leisure-time MVPA (<50 min of weekly leisure MVPA)
  • No health factors interfering with PA

排除标准

  • Anyone with a health condition precluding them from engaging in PA
  • Cognitive impairment preventing participation
  • Inability to complete the informed consent in English or Spanish
  • Attending other churches besides the church of recruitment

研究组 & 干预措施

Standard EBI Condition

Experimental

Faith in Action as originally implemented

干预措施: Faith in Action (Behavioral)

Enhanced Condition

Experimental

Standard condition + organizational-level implementation strategies

干预措施: Faith in Action+ (Behavioral)

Enhanced + Sustainment condition

Experimental

Enhanced implementation condition + maintenance strategies

干预措施: Faith in Action++ (Behavioral)

结局指标

主要结局

Individual Level: Change in Participants' Moderate to Vigorous Physical Activity (MVPA) from Baseline to Month 12

时间窗: 12 months

Investigators will assess the change in the number of minutes per day of participants' MVPA from baseline to month 12.

Organizational Level: Change in Innovation-Values fit from Baseline to Month 12

时间窗: 12 months

Investigators will survey FBO leaders, church staff, promotoras, and parishioners to assess the change in Innovation-values fit from baseline to month 12. Self-report questions regarding perceptions of the fit between the values of their FBO and the Faith in Action intervention will be measured using Likert scales (completely agree to completely disagree).

Individual Level: Change in Participants' Moderate to Vigorous Physical Activity (MVPA) from Baseline to Month 6

时间窗: 6 months

Investigators will assess the change in the number of minutes per day of participants' MVPA from baseline to month 6.

Organizational Level: Change in Innovation-Values fit from Baseline to Month 6

时间窗: 6 months

Investigators will survey FBO leaders, church staff, promotoras, and parishioners to assess the change in Innovation-values fit from baseline to month 6. Self-report questions regarding perceptions of the fit between the values of their FBO and the Faith in Action intervention will be measured using Likert scales (completely agree to completely disagree).

次要结局

  • Organizational Level: Maintenance of Promotoras' PA Class Delivery(18 months post-baseline)
  • Individual Level: Maintenance of Moderate to Vigorous Physical Activity (MVPA) at 18 months(18 months post-baseline)
  • Organizational Level: Maintenance of Promotoras' MI Calls(18 months post-baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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