Enhancing Capacity in Churches to Implement PA Programs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

677 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2027-01-31

Brief Summary

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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. Thirty-two 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=677) 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.

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Detailed Description

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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 32 FBOs to one of 3 conditions: a Standard implementation condition (n=8 FBOs), an Enhanced implementation condition (Standard + organizational implementation strategies; n=12 FBOs), or an Enhanced + Sustainment condition (Enhanced + sustainment strategies; n=12 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=12) will receive no additional support while FBOs in the Enhanced + Sustainment condition (n=12) 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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Triple

Study Groups

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Standard EBI Condition

Faith in Action as originally implemented

Group Type EXPERIMENTAL

Faith in Action

Intervention Type BEHAVIORAL

Interpersonal level: Group exercise classes offered 6 days/week (walking, cardio dance, strength training), Kickoff event

Individual level: Motivational Interviewing calls every 6 months, Health handouts on 14 topics distributed at PA classes

Enhanced Condition

Standard condition + organizational-level implementation strategies

Group Type EXPERIMENTAL

Faith in Action+

Intervention Type BEHAVIORAL

Standard Faith in Action Intervention plus: 1) Health Behavior Change Workshop for FBO leaders; 2) Targeted Messaging; and 3) Empowerment Training for Promotoras

Enhanced + Sustainment condition

Enhanced implementation condition + maintenance strategies

Group Type EXPERIMENTAL

Faith in Action++

Intervention Type BEHAVIORAL

Enhanced Condition plus: 1) Foster community collaborations and 2) Provide maintenance support

Interventions

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Faith in Action

Interpersonal level: Group exercise classes offered 6 days/week (walking, cardio dance, strength training), Kickoff event

Individual level: Motivational Interviewing calls every 6 months, Health handouts on 14 topics distributed at PA classes

Intervention Type BEHAVIORAL

Faith in Action+

Standard Faith in Action Intervention plus: 1) Health Behavior Change Workshop for FBO leaders; 2) Targeted Messaging; and 3) Empowerment Training for Promotoras

Intervention Type BEHAVIORAL

Faith in Action++

Enhanced Condition plus: 1) Foster community collaborations and 2) Provide maintenance support

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes