NCT05473871 Enhancing Capacity in Churches to Implement PA Programs
| NCT ID | NCT05473871 |
| Status | Recruiting |
| Phase | — |
| Sponsor | San Diego State University |
| Condition | Cardiovascular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 560 participants |
| Start Date | 2022-11-15 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 560 participants in total. It began in 2022-11-15 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
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
Contact & Investigator
Elva Arredondo, PhD
PRINCIPAL INVESTIGATOR
San Diego State University
Frequently Asked Questions
Who can join the NCT05473871 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05473871 currently recruiting?
Yes, NCT05473871 is actively recruiting participants. Contact the research team at earredon@sdsu.edu for enrollment information.
Where is the NCT05473871 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT05473871 clinical trial?
NCT05473871 is sponsored by San Diego State University. The principal investigator is Elva Arredondo, PhD at San Diego State University. The trial plans to enroll 560 participants.