Enhancing Capacity in Churches to Implement PA Programs

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorSan Diego State University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Faith in Action

    Behavioral

    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+

    Behavioral

    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++

    Behavioral

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

Treatment groups

560 Participants
are divided into 3 treatment groups
Group A: Standard EBI ConditionExperimental treatment 1 intervention
Group B: Enhanced ConditionExperimental treatment 1 intervention
Group C: Enhanced + Sustainment conditionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
6 months
2

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).

Time frame
12 months
3

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.

Time frame
6 months
4

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.

Time frame
12 months

Secondary outcomes

1

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.

Time frame
18 months post-baseline
2

Organizational Level: Maintenance of Promotoras' MI Calls

Investigators will assess if promotoras have made at least 1 MI call.

Time frame
18 months post-baseline
3

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.

Time frame
18 months post-baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

San Diego State University

Lead sponsor

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