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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • University of South Carolina
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Intervention
Walk Your Heart to Health program
Behavioral: Walk Your Heart to Health
32-week walking intervention delivered by church committees

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 29, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 29, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings