- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03858868
Linking Churches With Parks to Increase Physical Activity Among Latinos
March 13, 2024 updated by: Kathryn Derose, RAND
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
1204
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kathryn P Derose, PhD, MPH
- Phone Number: 6302 310-393-0411
- Email: derose@rand.org
Study Locations
-
-
California
-
Santa Monica, California, United States, 90401
- Recruiting
- RAND Corporation
-
Contact:
- Kathryn P Derose, PhD, MPH
- Phone Number: 6302 310-393-0411
- Email: derose@rand.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Church and park-based intervention
Participants at intervention churches will be offered: texting intervention (messages about physical activity); peer leader training; walking groups; park-based fitness classes; sermons; participation in park advisory board; community advocacy.
|
Multiple components involving motivational messages and concrete opportunities for physical activity at the church and the local park.
|
Other: Publicly available physical activity materials
Participants at control churches will be offered standard health educational materials (brochures, tip sheets, posters) about physical activity.
|
Participants will receive publicly available brochures, tip sheets, etc. about physical activity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in objectively measured physical activity
Time Frame: Change in physical activity between baseline and 12 months
|
Accelerometer-assessed moderate to vigorous physical activity at 12 months as compared to baseline
|
Change in physical activity between baseline and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fitness level
Time Frame: Change in fitness level between baseline and 12 months
|
Heart rate / fitness as measured by the 3 minute submaximal step test
|
Change in fitness level between baseline and 12 months
|
Change in waist circumference
Time Frame: Change in waist circumference between baseline and 12 months
|
Objectively measured waist circumference
|
Change in waist circumference between baseline and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kathryn P Derose, PhD, MPH, RAND
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 3, 2019
Primary Completion (Estimated)
April 30, 2025
Study Completion (Estimated)
April 30, 2026
Study Registration Dates
First Submitted
February 27, 2019
First Submitted That Met QC Criteria
February 28, 2019
First Posted (Actual)
March 1, 2019
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 13, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R01CA218188 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The final dataset will include self-reported and biometric variables at baseline, 6m and 12m.
These will be made available in the form of an electronic database for researchers who successfully complete a registration process.
Data will be de-identified and will not contain any direct or indirect identifiers.
We will provide a codebook and users 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.
Users must submit brief proposals regarding intended use of the data; the study 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 public use dataset.
IPD Sharing Time Frame
6 months after completion of final manuscripts.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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