Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05473871 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Enhancing Capacity in Churches to Implement PA Programs

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Enrollment target: 677 to 560
    • Primary completion date: Jan 1, 2027 to Feb 28, 2027
    • Study completion date: Jan 31, 2027 to Feb 28, 2027
    • Study description revised
    v7
  2. Minor Collaborators: 3 to 4v6
  3. Notable Primary completion date: May 1, 2026 to Jan 1, 2027
    • Enrollment target: 812 to 677
    • Study completion date: Oct 31, 2026 to Jan 31, 2027
    v5
  4. Minor Site contact updatedv4
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  6. Notable Start date: Aug 1, 2022 to Nov 15, 2022v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05473871
Lead Sponsor San Diego State University
Collaborators: Washington University School of Medicine, University of California, Berkeley, University of California, San Diego, National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)
Cardiovascular Diseases
Related terms Cardiovascular Diseases, Motor Activity
Enrollment 560 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov