Cardiovascular DiseasesNCT05473871
Enhancing Capacity in Churches to Implement PA Programs
A study testing Faith in Action, Faith in Action+ and Faith in Action++ in people with Cardiovascular Diseases, run by San Diego State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Faith in Action, Faith in Action+ and Faith in Action++
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2022to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
San Diego State University Research Foundation
San Diego, California, 92182
Isela Martinez, 619-594-3059, iselamartinez@sdsu.edu
Elva Arredondo, 619-594-6307, earredon@sdsu.edu
About this study
Official title: Enhancing Capacity in Faith-based Organizations to Implement and Sustain Multilevel Innovations to Improve Physical Activity
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.
Read the detailed 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 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Faith in Action, Faith in Action+, Faith in Action++
- Keywords
- Physical Activity, Faith in Action, Hispanic Women, Latinas, Exercise
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faith in ActionBehavioural
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+Behavioural
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++Behavioural
Enhanced Condition plus: 1) Foster community collaborations and 2) Provide maintenance support
| Study group | Role | What they receive |
|---|---|---|
| Standard EBI Condition | Experimental | Faith in Action as originally implemented Receives: Behavioral: Faith in Action |
| Enhanced Condition | Experimental | Standard condition + organizational-level implementation strategies Receives: Behavioral: Faith in Action+ |
| Enhanced + Sustainment condition | Experimental | Enhanced implementation condition + maintenance strategies Receives: Behavioral: Faith in Action++ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 18 months post-baseline
Organizational Level: Maintenance of Promotoras' MI Calls
Investigators will assess if promotoras have made at least 1 MI call.
Measured: 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.
Measured: 18 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start15 Nov 2022
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine, University of California, Berkeley, University of California, San Diego, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Elva Arredondo, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473871
- Sponsor's protocol ID
- HS-2020-0221
- Other IDs
- R01HL158538
- Status last verified
- Mar 2026
- First submitted
- 21 Jul 2022
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Arredondo EM, Schneider J, Chuang E, Rabin B, Lin CD, Brownson RC, Hooker SP, Torres-Ruiz MS, Telles V, Martinez SanRoman I, Chagolla D, Garcia-Villegas J, Gomez M, Formagini T, Lafuente O, Clark SD, Galvan MO, Ayala GX. Enhancing capacity in faith-based organizations to implement and sustain multilevel innovations to improve physical activity: study protocol for the faith in action type II hybrid implementation-effectiveness trial. BMC Public Health. 2026 Apr 10;26(1):1640. doi: 10.1186/s12889-026-27147-0.
PubMed 41963892
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Capacity in Faith-based Organizations to Implement and Sustain Multilevel Innovations to Improve Physical Activity
- ClinicalTrials.gov ID
- NCT05473871
- Acronym / sponsor ID
- HS-2020-0221
- Conditions
- Cardiovascular Diseases
- Keywords
- Physical Activity, Faith in Action, Hispanic Women, Latinas, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- Washington University School of Medicine, University of California, Berkeley, University of California, San Diego, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard EBI Condition | Experimental | Behavioral: Faith in ActionFaith in Action as originally implemented |
| Enhanced Condition | Experimental | Behavioral: Faith in Action+Standard condition + organizational-level implementation strategies |
| Enhanced + Sustainment condition | Experimental | Behavioral: Faith in Action++Enhanced implementation condition + maintenance strategies |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faith in ActionInterpersonal 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 | Behavioural | Standard EBI Condition |
| 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 | Behavioural | Enhanced Condition |
| Faith in Action++Enhanced Condition plus: 1) Foster community collaborations and 2) Provide maintenance support | Behavioural | Enhanced + Sustainment condition |
Primary outcome
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.
3 secondary outcomes
Organizational Level: Maintenance of Promotoras' PA Class Delivery
Time frame: 18 months post-baseline
Organizational Level: Maintenance of Promotoras' MI Calls
Time frame: 18 months post-baseline
Individual Level: Maintenance of Moderate to Vigorous Physical Activity (MVPA) at 18 months
Time frame: 18 months post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Derived from this study: PubMed 41963892Arredondo EM, Schneider J, Chuang E, Rabin B, Lin CD, Brownson RC, Hooker SP, Torres-Ruiz MS, Telles V, Martinez SanRoman I, Chagolla D, Garcia-Villegas J, Gomez M, Formagini T, Lafuente O, Clark SD, Galvan MO, Ayala GX. Enhancing capacity in faith-based organizations to implement and sustain multilevel innovations to improve physical activity: study protocol for the faith in action type II hybrid implementation-effectiveness trial. BMC Public Health. 2026 Apr 10;26(1):1640. doi: 10.1186/s12889-026-27147-0.
- Individual participant dataSharing planned: 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.
Related trials for Cardiovascular Diseases
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elva Arredondo, PhD principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Faith in Action, Faith in Action+ and Faith in Action++ in people with Cardiovascular Diseases, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elva Arredondo, PhD (619-594-3059, earredon@sdsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Organizational Level: Change in Innovation-Values fit from Baseline to Month 6 (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05473871, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.