Enhancing Capacity in Churches to Implement PA Programs

NCT05473871 | Recruiting DMC

• 2 other identifiers: HS-2020-0221R01HL158538
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

Physical Activity; Faith in Action; Hispanic Women; Latinas; Exercise

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• Organizational Level: Maintenance of Promotoras' PA Class Delivery

  18 months post-baseline

• Organizational Level: Maintenance of Promotoras' MI Calls

  18 months post-baseline

• Individual Level: Maintenance of Moderate to Vigorous Physical Activity (MVPA) at 18 months

  18 months post-baseline

Study Arms (3)

Standard EBI Condition

EXPERIMENTAL

Faith in Action as originally implemented

Behavioral: Faith in Action

Enhanced Condition

EXPERIMENTAL

Standard condition + organizational-level implementation strategies

Behavioral: Faith in Action+

Enhanced + Sustainment condition

EXPERIMENTAL

Enhanced implementation condition + maintenance strategies

Behavioral: Faith in Action++

Interventions

Faith in Action++ BEHAVIORAL

Enhanced Condition plus: 1) Foster community collaborations and 2) Provide maintenance support

Enhanced + Sustainment condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• San Diego State University: lead
• Washington University School of Medicine: collaborator
• University of California, Berkeley: collaborator
• University of California, San Diego: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

San Diego State University Research Foundation

San Diego, California, 92182, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Elva Arredondo, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elva Arredondo, PhD

CONTACT

619-594-3059; earredon@sdsu.edu

Isela Martinez, MPH, MA

CONTACT

619-594-6307; iselamartinez@sdsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 26, 2022
• Study Start: November 15, 2022
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available after initial data analyses and preparation of major publications.
• Access Criteria: Researchers interested in accessing the data must complete a registration process and must agree to the conditions of use, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource. Those interested in accessing data must submit a brief proposal describing the intended use of the data; the investigative team will determine the scientific soundness of the proposal, as well as whether adequate data protections in place, as part of the decision for the researcher to be able to access the dataset.

Locations

US (1)