Enhancing Capacity in Churches to Implement PA Programs

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05473871
• Other study ID #: R01HL158538
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: October 31, 2026

Study information

• Verified date: May 2024
• Source: San Diego State University
• Contact: Elva Arredondo, PhD
• Phone: 619-594-3059
• Email: earredon[@]sdsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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=812) 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 812
• Est. completion date: October 31, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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
• 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
• Faith in Action++
Enhanced Condition plus: 1) Foster community collaborations and 2) Provide maintenance support

Locations

Country	Name	City	State
United States	San Diego State University Research Foundation	San Diego	California

Sponsors (4)

Lead Sponsor	Collaborator
San Diego State University	University of California, Berkeley, University of California, San Diego, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	6 months
Primary	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).	12 months
Primary	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.	6 months
Primary	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.	12 months
Secondary	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.	18 months post-baseline
Secondary	Organizational Level: Maintenance of Promotoras' MI Calls	Investigators will assess if promotoras have made at least 1 MI call.	18 months post-baseline
Secondary	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.	18 months post-baseline