- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07340099
Church Implementation of a Social Support Intervention to Increase Physical Activity in Older African American Adults
January 5, 2026 updated by: Sara Wilcox, University of South Carolina
Community-Based Participatory Research to Study Church Implementation of an Evidence-Based Social Support Intervention to Increase Physical Activity Among Older African American Adults
Many effective interventions or programs are never put into practice.
This quasi-experimental study will partner with AME churches in two areas of South Carolina to study how an evidence-based program is put into place by the church.
The program, Walk Your Heart to Health, will include training in how churches can modify their practices to support physical activity and healthy eating.
Over the five-year study, the investgiators will examine factors that predict the success of putting the program into place, things that help and get in the way of putting the program into place, and how the program can be scaled up to reach even more churches.
The investigators will also examine the effect of the program (pre- to post-changes) on walking group member outcomes (physical activity and social cohesion).
The investigators expect to work with approximately 26 AME churches for this study.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
Physical activity (PA) plays a critical role in preventing and treating chronic disease and promoting quality of life across the age spectrum.
Older adults are a priority population for increasing PA as they experience disproportionate rates of chronic disease, are underactive, and their proportion of the US population is increasing.
The proposed study, which serves as the core research project for the University of South Carolina Prevention Research Center, uses a within-site pre-post study design (i.e., quasi-experimental) to study the implementation of Walk Your Heart to Health (WYHH) by AME Churches.
Churches will also receive training in how to modify organizational practices to support physical activity.
The study's primary focus is to study implementation outcomes.
The Consolidated Framework for Implementation Research will help inform three primary questions: (1) how do contextual factors influence implementation and sustainability success or failure?
(2) what barriers and facilitators to implementation exist?
and (3) how can the EBI be scaled up to broader regions or populations outside the research community?
Data from pastors and church implementers will come from multiple sources (surveys, interviews, etc.) and time points and will be analyzed using a matrixed multiple case study approach and rapid qualitative analysis.
The investigators will work with the CAB and other partners to ensure cultural relevance of intervention strategies and support materials in Year 1, pilot the implementation strategies and measurements in Year 2 (6 churches), conduct the implementation study in Years 3 and 4 (20 churches), and focus on translation and scale up activities in Year 5. A secondary focus is to study participant-level outcomes.
Increasing PA in older adults is a Healthy People 2030 goal.
Churches are vital but underutilized institutions for implementing EBIs that can contribute to reaching national priorities.
Study Type
Interventional
Enrollment (Estimated)
300
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: Sara Wilcox, PhD
- Phone Number: 803-777-8141
- Email: wilcoxs@mailbox.sc.edu
Study Locations
-
-
South Carolina
-
Columbia, South Carolina, United States, 29208
- University of South Carolina
-
Contact:
- Sara Wilcox, PhD
- Phone Number: 803-777-8141
- Email: wilcoxs@mailbox.sc.edu
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Member of participating church (Charleston or Columbia Districts of the 7th Episcopal District of the AME church) or is in larger neighborhood and able to attend
- Aged 50 years and older
- Agrees to participate in in-person walking group sessions
- Not planning to move in the next year from a location that would make study visits difficult
Exclusion Criteria:
- No contraindications to exercise, as determined by the PAR-Q
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Intervention
Walk Your Heart to Health program
|
32-week walking intervention delivered by church committees
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pedometer steps
Time Frame: baseline, 8 weeks, 32 weeks
|
Average steps per day from pedometer
|
baseline, 8 weeks, 32 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified version of Physical Activity Group Environment Questionnaire (Group Cohesion), as used in Walk Your Heart to Health effectiveness trial
Time Frame: 8 weeks, 32 weeks
|
A 21-item self-reported survey that assesses the subscales of task cohesion (6 items, scores can range from 6 to 30), social cohesion (6 items, scores can range from 6 to 30), perception of group integration around task factors (5 items, scores can range from 5 to 25), and perception of group integration around social factors (4 items, scores can range from 4 to 20).
For all subscales, higher scores indicate a greater sense of group cohesion or group integration.
|
8 weeks, 32 weeks
|
|
Modified Version of the Physical Activity Group Environment Questionnaire (Leader Behaviors), as used in Walk Your Heart to Health effectiveness trial
Time Frame: 8 weeks, 32 weeks
|
A 13-item self-report measure of how participants view the behaviors of their walking leaders.
Possible scores can range from 13 to 65, with higher scores indicating more positive leader behaviors.
|
8 weeks, 32 weeks
|
|
Supportive Accountability Inventory
Time Frame: 8 weeks, 32 weeks
|
An 8-item self-report measure that assesses the degree to which the participant feels a sense of accountability to their walking group.
Scores can range from 8 to 56, with higher scores indicating a greater sense of accountability to the walking group.
|
8 weeks, 32 weeks
|
|
Health-Related Quality of Life (EuroQol 5 Dimensions 5 Levels; EQ-5D-5L)
Time Frame: baseline, 8 weeks, 32 weeks
|
A 5-item self-reported measure that assesses the participants' ratings of quality of life in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression.
For each item, the participant chooses a statement (from a list of 5) that best describes them.
Scores for each area range from 1 to 5 (1=no impairment; 5 = extreme impairment).
Scores will be presented as the percentage of participants in each level for each dimension.
A total score will also be computed.
Possible scores on the scale range from 11111 (best possible score - no impairment on any of the 5 dimension) to 55555 (worse possible score - extreme impairments on all 5 dimensions).
The score will be converted into a single index value based on country-specific norms.
|
baseline, 8 weeks, 32 weeks
|
|
Self-Efficacy for Exercise Scale
Time Frame: baseline, 8 weeks, 32 weeks
|
A 7-item modified self-report scale in whcih participants report confidence in their ability to overcome barriers to walking 3 times per week for 50 minutes each time.
Each item is rated from 0 (not confident) to 10 (very confident).
Items are summed and divided by 7 so that the total score can range from 0 to 10, with higher scores indicating greater self-efficacy to overcome barriers to walking.
|
baseline, 8 weeks, 32 weeks
|
|
The UCLA 3-Item Loneliness Scale
Time Frame: baseline, 8 weeks, 32 weeks
|
A 3-item measure that assesses 3 dimension of loneliness: relational connectedness, social connectedness, and perceived isolation.
For each item, participants rate how often they experience each dimension ranging from 1 (hardly ever), to 2 (some of the time), to 3 (often).
Total scores can range from 3 to 9, with higher scores indicating greater loneliness.
Participants who score 3-5 are typically considered "not lonely" whereas those who score 6 to 9 are typically considered "lonely."
|
baseline, 8 weeks, 32 weeks
|
|
Church practices and policies
Time Frame: baseline, 8 weeks, 32 weeks
|
An 11-item self-report scale used in the investigator's previous studies.
Participants report how often there are opportunities, messages, and pastor support for physical activity at their church as well as the presence of policies that support physical activity.
Scores for each dimension are created ranging from 1 to 4 (higher scores indicate more favorable practices/policies).
A composite score which is the average of the four dimensions is also created, ranging from 1 to 4, interpreted the same way.
|
baseline, 8 weeks, 32 weeks
|
|
Self-Reported Physical Activity
Time Frame: baseline, 8 weeks, 32 weeks
|
Participants are asked whether, in a usual week not including time at work, they do moderate or vigorous physical activity (yes or no), and if yes, how many days and how much total time per day.
For those who report they do some physical activity, the investigators multiple days by time to get minutes per week of physical activity.
Investigators then clasify participants as inactive (report no physical activity), underactive (report less than 150 minutes per week of physical activity), or regularly active (report 150 minutes or more per week of physical activity).
The items are based on the Behavioral Risk Factor Surveillance System questionnaire.
|
baseline, 8 weeks, 32 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sara Wilcox, PhD, University of South Carolina
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 (Estimated)
April 1, 2026
Primary Completion (Estimated)
September 29, 2028
Study Completion (Estimated)
September 29, 2029
Study Registration Dates
First Submitted
December 22, 2025
First Submitted That Met QC Criteria
January 5, 2026
First Posted (Actual)
January 14, 2026
Study Record Updates
Last Update Posted (Actual)
January 14, 2026
Last Update Submitted That Met QC Criteria
January 5, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00138947
- U48DP006780 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Free public access to de-identified participant data will be provided within 30 months of completion of the project.
Data will include all primary and secondary outcomes along with basic descriptive information.
IPD Sharing Time Frame
Free public access to de-identified participant data will be provided within 30 months of completion of the project.
The investigators will use an external housing source to keep data available from the site.
IPD Sharing Access Criteria
Free, open source access.
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
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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