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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03858868
Other study ID # R01CA218188
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 3, 2019
Est. completion date April 30, 2026

Study information

Verified date March 2024
Source RAND
Contact Kathryn P Derose, PhD, MPH
Phone 310-393-0411
Email derose@rand.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a cluster randomized controlled trial of a multi-level intervention that links Latino Catholic churches (n=14) with their local parks to increase physical activity among Latino parishioners (n=1204) in Los Angeles. The study will examine the impact of the intervention on Latino parishioners' PA and health-related outcomes; explore differences in the intervention's effectiveness by gender; and evaluate factors associated with implementation for future dissemination. If successful, the intervention has the potential for sustainability and scale-up across the largest diocese in the U.S. and potentially across the nation.


Description:

Engaging in regular physical activity (PA) contributes to positive health outcomes, including longevity, better quality of life, and reduced incidence of cardiovascular diseases, diabetes, depression, certain cancers, and obesity; however, only a minority of U.S. adults meet the minimum guidelines for moderate to vigorous PA (MVPA), and Latinos are less likely than whites to report meeting the guidelines. Public parks comprise local infrastructure that can be leveraged for community PA, but tend to be underutilized, particularly in low-income communities. Parks in low-income and minority communities tend to have less PA programming, especially targeting adults, and higher crime and other factors that affect park use. There is a need for interventions that address community concerns, target the built environment, and "activate" park use. Churches are credible, stable entities that have significant reach within Latino communities and a history of social service provision and advocacy related to health and well-being. The investigators' prior research has found that church-based interventions can be effective across a wide range of health issues and types of churches. This study combines approaches from the research team's extensive prior work with churches and parks to conduct a cluster randomized controlled trial of a multi-level intervention that links Latino Catholic churches (n=14) with their local parks to increase PA among Latino parishioners (n=1204) in Los Angeles. The specific aims are to: (1) Examine the impact of a multi-level church-based intervention that links Catholic parishes to their local parks on Latino parishioners' PA and health-related outcomes (effects on parishioners' MVPA and self-reported PA, heart rate/fitness, waist circumference, waist to hip ratio, body fat, mental health, and perceived social support for PA); (2) Explore differences in the effectiveness of the intervention by gender; and (3) Evaluate factors associated with intervention implementation (facilitators, barriers, fidelity, and replication costs) for future dissemination. The approach targets multiple levels to promote health-enhancing PA through park-based fitness classes led by kinesiology students, peer leader-led walking groups, park-based church events, and church-based PA support activities. It integrates churches' vast social networks, moral authority, and influence with parks' structural and organizational capacity and kinesiology student interns' professional expertise. The intervention makes use of innovative partnerships within and across sectors - faith-based, local parks/city government, and local universities. The inter-sectoral, collaborative approach makes the intervention scalable and sustainable in real-world settings and incorporates action at multiple levels (individuals, churches, and neighborhoods). To the investigators' knowledge, this will be the first study to examine the effectiveness of an integrated church and park-based intervention on Latinos' PA, and it will provide a sustainable model of PA programming in low-income communities. If the intervention proves effective, the increased community capacity through this partnership will lay the groundwork for scale-up across the largest diocese in the U.S. and, potentially, the nation.


Recruitment information / eligibility

Status Recruiting
Enrollment 1204
Est. completion date April 30, 2026
Est. primary completion date April 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Does not currently meet physical activity guidelines (150 minutes per week) - Regularly attends study church - Does not have health condition that would preclude physical activity Exclusion Criteria: - Regularly engages in 150 minutes or more of moderate to vigorous physical activity - Does not regularly attend study church - Has health condition that would preclude physical activity

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Church and park-based intervention
Multiple components involving motivational messages and concrete opportunities for physical activity at the church and the local park.
Standard health education on physical activity
Participants will receive publicly available brochures, tip sheets, etc. about physical activity

Locations

Country Name City State
United States RAND Corporation Santa Monica California

Sponsors (3)

Lead Sponsor Collaborator
RAND California State University, Los Angeles, San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in objectively measured physical activity Accelerometer-assessed moderate to vigorous physical activity at 12 months as compared to baseline Change in physical activity between baseline and 12 months
Secondary Change in fitness level Heart rate / fitness as measured by the 3 minute submaximal step test Change in fitness level between baseline and 12 months
Secondary Change in waist circumference Objectively measured waist circumference Change in waist circumference between baseline and 12 months
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