An interventional study of Faith in Action and Faith in Action+ in Cardiovascular Diseases, sponsored by San Diego State University. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by San Diego State University · Not applicable, Interventional, and Prevention
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.
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's planned enrollment of 560 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →San Diego State University is the lead sponsor of 145 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
Faith in Action as originally implemented
Behavioral: Faith in Action
Standard condition + organizational-level implementation strategies
Behavioral: Faith in Action+
Enhanced implementation condition + maintenance strategies
Behavioral: 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
Standard Faith in Action Intervention plus: 1) Health Behavior Change Workshop for FBO leaders; 2) Targeted Messaging; and 3) Empowerment Training for Promotoras
Enhanced Condition plus: 1) Foster community collaborations and 2) Provide maintenance support
Organizational Level: Change in Innovation-Values fit from Baseline to Month 6
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).
Time frame: 6 months
Organizational Level: Change in Innovation-Values fit from Baseline to Month 12
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).
Time frame: 12 months
Individual Level: Change in Participants' Moderate to Vigorous Physical Activity (MVPA) from Baseline to Month 6
Investigators will assess the change in the number of minutes per day of participants' MVPA from baseline to month 6.
Time frame: 6 months
Individual Level: Change in Participants' Moderate to Vigorous Physical Activity (MVPA) from Baseline to Month 12
Investigators will assess the change in the number of minutes per day of participants' MVPA from baseline to month 12.
Time frame: 12 months
Organizational Level: Maintenance of Promotoras' PA Class Delivery
Investigators will assess if the promotoras are delivering at least 3 PA classes per week at their church.
Time frame: 18 months post-baseline
Organizational Level: Maintenance of Promotoras' MI Calls
Investigators will assess if promotoras have made at least 1 MI call.
Time frame: 18 months post-baseline
Individual Level: Maintenance of Moderate to Vigorous Physical Activity (MVPA) at 18 months
Investigators will compare the number of minutes of participants' MVPA per day at 18 months to baseline, 6, and 12 months, to assess maintenance of MVPA at 18 months, which will be 6 months after the intervention has ended.
Time frame: 18 months post-baseline
Plan to share: Yes — The final dataset will be an electronic database containing objective (BMI and Blood Pressure) and self-report (survey with primary and secondary outcomes, demographic information, etc.) variables from baseline, 6, 12, and 18 months. Data will be de-identified to remove all subject identifiers.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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