Clinical trial NCT05473871: Enhancing Capacity in Churches to Implement PA Programs
Official title: Enhancing Capacity in Faith-based Organizations to Implement and Sustain Multilevel Innovations to Improve Physical Activity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Physical Activity
Faith in Action
Hispanic Women
Latinas
Exercise
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
name: University of California, Berkeley
name: University of California, San Diego
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-07-26
Enrollment: 677
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Organizational Level: Change in Innovation-Values fit from Baseline to Month 6
timeFrame: 6 months
measure: Organizational Level: Change in Innovation-Values fit from Baseline to Month 12
timeFrame: 12 months
measure: Individual Level: Change in Participants' Moderate to Vigorous Physical Activity (MVPA) from Baseline to Month 6
timeFrame: 6 months
measure: Individual Level: Change in Participants' Moderate to Vigorous Physical Activity (MVPA) from Baseline to Month 12
timeFrame: 12 months
Secondary outcomes:
measure: Organizational Level: Maintenance of Promotoras' PA Class Delivery
timeFrame: 18 months post-baseline
measure: Organizational Level: Maintenance of Promotoras' MI Calls
timeFrame: 18 months post-baseline
measure: Individual Level: Maintenance of Moderate to Vigorous Physical Activity (MVPA) at 18 months
timeFrame: 18 months post-baseline
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University Research Foundation
state: California
Study officials:
affiliation: San Diego State University
name: Elva Arredondo, PhD
role: PRINCIPAL_INVESTIGATOR
References: