Healthy ParticipantsNCT07340099
Church Implementation of a Social Support Intervention to Increase Physical Activity in Older African American Adults
A study testing Walk Your Heart to Health in people with Healthy Participants and Chronic Diseases in Older Adults, run by University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Chronic Diseases in Older Adults, Chronic Disease Prevention
- What is being tested?
- Walk Your Heart to Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 29 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No contraindications to exercise, as determined by the PAR-Q
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
Sara Wilcox, PhD, 803-777-8141, wilcoxs@mailbox.sc.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- Walk Your Heart to Health
- Keywords
- physical activity, walking, health promotion, chronic disease prevention, older adults
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk Your Heart to HealthBehavioural
32-week walking intervention delivered by church committees
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Walk Your Heart to Health program Receives: Behavioral: Walk Your Heart to Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pedometer steps
Average steps per day from pedometer
Measured: baseline, 8 weeks, 32 weeks
Secondary outcomes (8)
Modified version of Physical Activity Group Environment Questionnaire (Group Cohesion), as used in Walk Your Heart to Health effectiveness trial
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.
Measured: 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
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.
Measured: 8 weeks, 32 weeks
Supportive Accountability Inventory
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.
Measured: 8 weeks, 32 weeks
Health-Related Quality of Life (EuroQol 5 Dimensions 5 Levels; EQ-5D-5L)
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.
Measured: baseline, 8 weeks, 32 weeks
Self-Efficacy for Exercise Scale
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.
Measured: baseline, 8 weeks, 32 weeks
The UCLA 3-Item Loneliness Scale
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."
Measured: baseline, 8 weeks, 32 weeks
Church practices and policies
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.
Measured: baseline, 8 weeks, 32 weeks
Self-Reported Physical Activity
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.
Measured: baseline, 8 weeks, 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Apr 2026 (estimated)
- Primary completion29 Sep 2028 (estimated)
- Study completion29 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Sara Wilcox, University of South Carolina
- Investigators
- Sara Wilcox, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340099
- Sponsor's protocol ID
- Pro00138947
- Other IDs
- U48DP006780
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Participatory Research to Study Church Implementation of an Evidence-Based Social Support Intervention to Increase Physical Activity Among Older African American Adults
- ClinicalTrials.gov ID
- NCT07340099
- Acronym / sponsor ID
- Pro00138947
- Keywords
- physical activity, walking, health promotion, chronic disease prevention, older adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 29 Sep 2028 (estimated)
- Study completion
- 29 Sep 2029 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Walk Your Heart to HealthWalk Your Heart to Health program |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- No contraindications to exercise, as determined by the PAR-Q
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walk Your Heart to Health32-week walking intervention delivered by church committees | Behavioural | Intervention |
Primary outcome
Pedometer steps
Time frame: baseline, 8 weeks, 32 weeks
Average steps per day from pedometer
8 secondary outcomes
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
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
Supportive Accountability Inventory
Time frame: 8 weeks, 32 weeks
Health-Related Quality of Life (EuroQol 5 Dimensions 5 Levels; EQ-5D-5L)
Time frame: baseline, 8 weeks, 32 weeks
Self-Efficacy for Exercise Scale
Time frame: baseline, 8 weeks, 32 weeks
The UCLA 3-Item Loneliness Scale
Time frame: baseline, 8 weeks, 32 weeks
Church practices and policies
Time frame: baseline, 8 weeks, 32 weeks
Self-Reported Physical Activity
Time frame: baseline, 8 weeks, 32 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara Wilcox, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walk Your Heart to Health in people with Healthy Participants and Chronic Diseases in Older Adults, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Wilcox, PhD (803-777-8141, wilcoxs@mailbox.sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pedometer steps (time frame: baseline, 8 weeks, 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.