NCT05473871 · San Diego State University
Enhancing Capacity in Churches to Implement PA Programs
What this study is about
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.
View original scientific description
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.
Interventions
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
BEHAVIORAL
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
BEHAVIORAL
Faith in Action++
Enhanced Condition plus: 1) Foster community collaborations and 2) Provide maintenance support
Primary outcome measures
Organizational Level: Change in Innovation-Values fit from Baseline to Month 6
Time frame: 6 months
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).
Organizational Level: Change in Innovation-Values fit from Baseline to Month 12
Time frame: 12 months
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).
Individual Level: Change in Participants' Moderate to Vigorous Physical Activity (MVPA) from Baseline to Month 6
Time frame: 6 months
Investigators will assess the change in the number of minutes per day of participants' MVPA from baseline to month 6.
Individual Level: Change in Participants' Moderate to Vigorous Physical Activity (MVPA) from Baseline to Month 12
Time frame: 12 months
Investigators will assess the change in the number of minutes per day of participants' MVPA from baseline to month 12.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- San Diego, California
Collaborators
Washington University School of Medicine, University of California, Berkeley, University of California, San Diego, National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 5, 2026 · Source of record for eligibility and locations