Heart DiseasesNCT05002660
The Change Club Study: Evaluation of Civic Engagement for Built Environment Change and Health Improvement
A study testing Group 1 (Intervention) in people with Heart Diseases, run by Texas A&M University at 13 sites in United States.
Trial summary
This is a community randomized controlled trial to evaluate a civic engagement curriculum through which residents will identify barriers and facilitators to healthy eating and physical activity and then implement a project in their communities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Group 1 (Intervention)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,420 participants
- Where
- 13 sitesUnited States
- Study dates
- 3 May 2023to 23 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- We will be recruiting Change Club members (CCM), friend and family members (FFM) of CCM, and community residents (CR).
- Common inclusion criteria include:
- Age 18-99
- English-speaking
- CCM also must:
- Provide consent electronically
Show all 15Show fewer
- Be willing to be randomized to either group
- Score "poor" or "intermediate" on at least one of the Simple 7 composite score items (e.g. not meeting Physical Activity Guidelines for Americans)
- Live in one of the designated towns in NY and TX
- FFM also must:
- Provide consent electronically
- Be family members or friends identified by a CCM
- CR also must:
- Provide consent electronically
- Live in one of the designated towns in NY and TX
Who cannot join
- Cognitive impairment (if it precludes completion of assessments and/or intervention)
- Inability to communicate due to severe, uncorrectable hearing loss or speech disorder (if it precludes completion of assessments and/or intervention)
- Severe visual impairment (if it precludes completion of assessments and/or intervention)
- Inability to read (as it precludes completion of assessments and/or intervention)
- Already included in another study sample (e.g. CR cannot also be CCM)
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Camden and surrounding towns
Camden, New York, 13316
Canastota
Canastota, New York, 13032
Carthage and surrounding towns
Carthage, New York, 13619
Center and Shelbyville
Center, Texas, 75973, 75935
Groveton and Woodlake
Groveton, Texas, 75845, 75865
Hamilton and surrounding towns
Hamilton, New York, 13346,13355,13334,13310,13402
Littlefield and surrounding towns
Littlefield, Texas, 79339
Marshall
Marshall, Texas, 75670, 75671, 75672
Plainview
Plainview, Texas, 79072, 79073
Rome
Rome, New York, 13308, 13440-2, 13449, 13478
Hounsfield and surrounding towns
Sackets Harbor, New York, 13685
Trinity
Trinity, Texas, 75862
Watertown
Watertown, New York, 13601, 13602, 13603
About this study
Official title: Evaluation of a Civic Engagement Approach to Catalyze Built Environment Change and Promote Healthy Eating and Physical Activity Among Rural Residents
This is a community randomized controlled trial to evaluate a civic engagement curriculum through which residents will identify barriers and facilitators to healthy eating and physical activity and then implement a project in their communities.
Read the detailed description
The purpose of this research is to better understand how resident-led activities to change the community environment affect health. The Change Club is a small group of residents who will try to change their community environment relative to food (for example, foods in restaurants or schools) or physical activity opportunities (for example, parks or walking trails) by following a step-wise process facilitated by an extension educator. The purpose of this research is to better understand if and how these activities affect individual behaviors (for example physical activity) and health outcomes (for example BMI) of adults in rural communities.
This study will take place in designated rural communities in Texas and New York. It is planned that about 2,260 people will participate in this study. Some will participate as Change Club members; some will participate as family and friends of Change Club members; and others will participate as community residents.
- Conditions
- Heart Diseases
- Being tested
- Group 1 (Intervention), Group 2 (Control)
- Keywords
- Physical Activity, Built Environment, Eating Habits
- Medical subject headings
- Heart Diseases, Motor Activity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 (Intervention)Behavioural
The investigators will evaluate the efficacy of the CC curriculum in a 24-months community-based randomized controlled trial. They will compare changes in CVD-related anthropometric, behavioral, and psychosocial parameters between subjects in intervention and control communities.
Group 2 (Control)Behavioural
Group 2 will be offered the same activities as Group 1 after the conclusion of the research study.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Intervention) | Experimental | For Change Club members (CCM) only: CCM will participate in meetings of the Change Club and continue implementation of a change to the community environment for up to an additional 24 months. Change Club members will also be asked to recruit 10 or more friends and family members (FFM) to participate in the research study.
In addition, 100 community residents (CR) will be recruited into the study. Family members, friends and community residents do not participate in the Change Club, but may hear about Change Club activities in their community. Receives: Behavioral: Group 1 (Intervention) |
| Group 2 (Control) | Experimental | Control group participants will participate in no intervention activities during the 3-year research study. Receives: Behavioral: Group 2 (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in American Heart Association's Life's Simple 7 (LS7) cardiovascular health score
American Heart Association's Life's Simple 7 (LS7) score is a composite of cardiovascular disease (CVD) risk factors (physical activity, eating habits, smoking status, cholesterol, glucose, body mass index (BMI), and blood pressure). Score ranges from 0 to 14. Higher scores indicate better health.
Measured: Baseline to 24 months
Secondary outcomes (36)
Change in body mass index (BMI)
Height and weight will be self-measured and BMI will be calculated.
Measured: Baseline to 24 months
Change in waist circumference
Waist circumference (cm(in)) will be self-measured.
Measured: Baseline to 24 months
Percent with high/elevated blood pressure
Percent with high/elevated blood pressure will be classified from self-reported measurements, diagnosis, and medication use.
Measured: Baseline to 24 months
Percent with high/borderline high cholesterol.
Percent with high/borderline high cholesterol will be classified from self-reported measurements, diagnosis, and medication use.
Measured: Baseline to 24 months
Percent with diabetes/prediabetes
Percent with diabetes/ prediabetes will be classified from self-reported measurements, diagnosis, and medication use.
Measured: Baseline to 24 months
Change in general health status
General health status will be assessed using the general health question from the 36-Item Short Form Survey (SF-36). Scores range from 1 to 5. Higher scores indicate better health.
Measured: Baseline to 24 months
Current smoker (y/n)
Whether or not a participant currently smokes will be assessed using an LS7 item.
Measured: Baseline to 24 months
Change in total HEI score
Total Healthy Eating Index (HEI) score will be calculated from a single 24-hour recall collected via the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24). Score ranges from 0 to 100. Higher scores indicate better diet.
Measured: Baseline to 24 months
Change in fruit and vegetable intake
Total fruit and vegetable intake (cups/day) will be measured using a LS7 item and a 24-hour recall.
Measured: Baseline to 24 months
Change in consumption of whole grains
Whole grain consumption (servings/day) will be assessed using an LS7 item and a 24-hour recall.
Measured: Baseline to 24 months
Change in fiber intake
Fiber intake (g/day) will be assessed using the NHANES Dietary Screener Questionnaire (DSQ) and a 24-hour recall.
Measured: Baseline to 24 months
Met recommendation for fish consumption (y/n)
Whether or not a participant met the recommendation for fish consumption will be assessed using an LS7 item.
Measured: Baseline to 24 months
Change in frequency of consuming ultra-processed foods
Frequency of ultra-processed foods consumption (times/month) will be assessed using a 9-item questionnaire adapted from the DSQ and the Beverage and Snack Questionnaire (BSQ2) and a 24-hour recall.
Measured: Baseline to 24 months
Change in red and processed meat consumption
Total red and processed meat consumption (g/week) will be estimated using the DSQ and a 24-hour recall.
Measured: Baseline to 24 months
Change in alcohol consumption
Alcohol consumption (drinks/day) will be assessed using a 2-item questionnaire adapted from the Alcohol Use Disorders Screening Test (AUDIT) and a 24-hour recall.
Measured: Baseline to 24 months
Change in total steps per day
Total steps per day will be calculated using the average of self-reported pedometer or wearable fitness tracker readings.
Measured: Baseline to 24 months
Change in total physical activity
Total physical activity (MET-min/wk) will be assessed using the International Physical Activity Questionnaire long form (IPAQ-long).
Measured: Baseline to 24 months
Change in World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) recommendation adherence score
WCRF/AICR recommendation adherence score is a composite of seven items listed above: BMI, physical activity, fiber intake, fruit and vegetable consumption, processed food consumption, red meat consumption, and alcohol consumption. Scores range from 0 to 7. Higher scores indicate greater adherence to the recommendations.
Measured: Baseline to 24 months
Change in healthy eating motivation
Healthy eating motivation will be assessed by an adapted version of the Naughton \& McCarthy Healthy Eating Motivation scale (3 items). Scores range from 1 to 5. Higher scores indicate greater motivation.
Measured: Baseline to 24 months
Change in confidence for healthy eating
Confidence for healthy eating will also be assessed by using a newly created scale (7 items) adapted from the Sallis Eating Habits Confidence Survey and the Seguin-Fowler Expanded Eating Habits Confidence Survey (7 items). Scores range from 1 to 5. Higher scores indicate greater confidence.
Measured: Baseline to 24 months
Change in social support for healthy eating
Social support (family and friends) for healthy eating will be assessed by the Ball Social Support for Healthy Eating scale. Scores range from 1 to 5. Higher scores indicate greater social support.
Measured: Baseline to 24 months
Change in exercise attitudes
Exercise attitudes will be assessed using selected items adapted from section 2, question 5 of the AARP Exercise Attitudes and Behaviors Survey (4 items). Scores range from 1 to 5. Higher scores indicate more positive attitudes.
Measured: Baseline to 24 months
Change in exercise confidence
Exercise confidence will be assessed by an adapted version of the Sallis Exercise Confidence Survey (3 items). Scores range from 1 to 5. Higher scores indicate greater confidence.
Measured: Baseline to 24 months
Change in social support for physical activity
Social support (family and friends) for physical activity will be assessed by the Ball Social Support for Physical Activity scale. Scores range from 1 to 5. Higher scores indicate greater social support.
Measured: Baseline to 24 months
Change in social engagement
Social engagement (family and friends) will be assessed by the Lubben Social Network Scale. Scores range from 1 to 5. Higher scores indicate greater social engagement.
Measured: Baseline to 24 months
Change in (community) social cohesion
Community social cohesion will be assessed by the social cohesion sub-scale of the Mujahid et al. Neighborhood Environment Scale (NES). Scores range from 1 to 5. Higher scores indicate greater social cohesion.
Measured: Baseline to 24 months
Change in individual mobilization
Individual mobilization will be assessed using the human capital sub-scale of the Jakes \& Shannon Mobilization Scale - Individual. Scores range from 1 to 5. Higher scores indicate greater mobilization.
Measured: Baseline to 24 months
Change in general civic engagement attitudes
Civic engagement attitudes will be assessed by the attitudes sub-scale of the Doolittle \& Faul Civic Engagement Scale. Scores range from 1 to 5. Higher scores indicate more positive civic engagement attitudes.
Measured: Baseline to 24 months
Change in general civic engagement behaviors
Civic engagement behaviors will be assessed by the behaviors sub-scale of the Doolittle \& Faul Civic Engagement Scale. Scores range from 1 to 5. Higher scores indicate more frequent civic engagement behaviors.
Measured: Baseline to 24 months
Change in investment in community health
Investment in community health (number of priorities) will be assessed using the investment in community health sub-scale of the RWJF National Survey of Health Attitudes. Scores range from 0 to 5. Higher scores indicate higher priority placed on community health.
Measured: Baseline to 24 months
Change in walking environment
Walking environment will be assessed by an adapted walking sub-scale of the NES (7 items). Scores range from 1 to 5. Higher scores indicate more favorable walking environments.
Measured: Baseline to 24 months
Change in neighborhood safety
Neighborhood safety will be assessed by an adapted neighborhood safety sub-scale of the NES (3 items). Scores range from 1 to 5. Higher scores indicate greater neighborhood safety.
Measured: Baseline to 24 months
Change in neighborhood aesthetic
Neighborhood aesthetic quality will be assessed by an adapted neighborhood aesthetic sub-scale of the NES (2 items). Scores range from 1 to 5. Higher scores indicate a more favorable neighborhood.
Measured: Baseline to 24 months
Change in fresh fruit and vegetable availability
Fresh fruit and vegetable availability will be assessed by an adapted fresh fruit and vegetable availability sub-scale (3 items) of the Green \& Glanz Perceived Nutrition Environment Measures Survey (NEMS-P). Scores range from 1 to 5. Higher scores indicate greater availability.
Measured: Baseline to 24 months
Change in store selection motivation
Store selection motivation will be assessed by an adapted store selection motivation sub-scale from NEMS-P (3 items). Scores range from 1 to 5. Higher scores indicate greater motivation.
Measured: Baseline to 24 months
Change in restaurant healthy food availability
Restaurant healthy food availability will be assessed by an adapted restaurant healthy food availability sub-scale from NEMS-P (2 items). Scores range from 1 to 5. Higher scores indicate greater availability of healthy food in restaurants.
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start3 May 2023
- Primary completion23 Apr 2026
- Study completion23 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Community-based cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 2,420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University, Tufts University
- Responsible party
- Sponsor
- Investigators
- Rebecca A. Seguin-Fowler, PhD, Principal investigator, Texas A&M AgriLife Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002660
- Sponsor's protocol ID
- R01CA230738
- Status last verified
- Oct 2025
- First submitted
- 4 Aug 2021
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Seguin-Fowler RA, Graham ML, Eldridge GD, Folta SC, Szeszulski J, MacMillan Uribe AL, Marshall GA, Villarreal DL, Volpe LC, Maddock JE, Nelson ME. Implementation of and Recommendations From the Change Club Civic Engagement Curriculum Targeting Health Behavior Improvement. Am J Health Promot. 2026 Aug 17:8901171261478393. doi: 10.1177/08901171261478393. Online ahead of print.
PubMed 42608888Seguin-Fowler RA, Hanson KL, Eldridge GD, Marshall GA, Maddock JE, Folta SC, Villarreal DL, Graham ML. The Change Club intervention: 2-year impacts from a cluster-randomized trial in rural communities in New York and Texas. Front Public Health. 2026 Jul 2;14:1793324. doi: 10.3389/fpubh.2026.1793324. eCollection 2026.
PubMed 42465624Seguin-Fowler RA, Graham ML, Hanson KL, Villarreal DL, Eldridge GD, Christou A, On A, Kershaw M, Folta SC, Maddock JE, Andreyeva E. Effective and cost-effective strategies for recruiting rural adults into a civic engagement and health behavior change research study. BMC Public Health. 2026 May 22;26(1):2179. doi: 10.1186/s12889-026-27592-x.
PubMed 42174511Graham ML, Lewis EC, Villarreal DL, Folta SC, Volpe LC, Eldridge GD, Hanson KL, Marshall GA, Maddock JE, Nelson ME, Seguin-Fowler RA. Implementation of Change Club action plans to promote built environment change in rural communities. Int J Behav Nutr Phys Act. 2026 Mar 31;23(1):49. doi: 10.1186/s12966-026-01908-x.
PubMed 41918127Graham ML, Eldridge GD, Demment M, Kershaw M, Christou A, Luong V, Andreyeva E, Folta SC, Hanson KL, Maddock JE, Seguin-Fowler RA. Leadership Characteristics of Extension Agents Facilitating a Healthy Communities, Civic-Engagement Randomized Trial in Rural Towns. J Healthy Eat Act Living. 2024 Dec 1;4(3):174-188. eCollection 2024.
PubMed 40385265Seguin-Fowler RA, Hanson KL, Villarreal D, Rethorst CD, Ayine P, Folta SC, Maddock JE, Patterson MS, Marshall GA, Volpe LC, Eldridge GD, Kershaw M, Luong V, Wang H, Kenkel D. Evaluation of a civic engagement approach to catalyze built environment change and promote healthy eating and physical activity among rural residents: a cluster (community) randomized controlled trial. BMC Public Health. 2022 Sep 4;22(1):1674. doi: 10.1186/s12889-022-13653-4.
PubMed 36058913
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Civic Engagement Approach to Catalyze Built Environment Change and Promote Healthy Eating and Physical Activity Among Rural Residents
- ClinicalTrials.gov ID
- NCT05002660
- Acronym / sponsor ID
- R01CA230738
- Conditions
- Heart Diseases
- Keywords
- Physical Activity, Built Environment, Eating Habits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,420 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Cornell University, Tufts University
- Study start
- 3 May 2023 (actual)
- Primary completion
- 23 Apr 2026 (actual)
- Study completion
- 23 Apr 2026 (actual)
- First posted
- 12 Aug 2021 (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.
This is a community randomized controlled trial to evaluate a civic engagement curriculum through which residents will identify barriers and facilitators to healthy eating and physical activity and then implement a project in their communities.
Detailed description
The purpose of this research is to better understand how resident-led activities to change the community environment affect health. The Change Club is a small group of residents who will try to change their community environment relative to food (for example, foods in restaurants or schools) or physical activity opportunities (for example, parks or walking trails) by following a step-wise process facilitated by an extension educator. The purpose of this research is to better understand if and how these activities affect individual behaviors (for example physical activity) and health outcomes (for example BMI) of adults in rural communities.
This study will take place in designated rural communities in Texas and New York. It is planned that about 2,260 people will participate in this study. Some will participate as Change Club members; some will participate as family and friends of Change Club members; and others will participate as community residents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Community-based cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Intervention) | Experimental | Behavioral: Group 1 (Intervention)For Change Club members (CCM) only: CCM will participate in meetings of the Change Club and continue implementation of a change to the community environment for up to an additional 24 months. Change Club members will also be asked to recruit 10 or more friends and family members (FFM) to participate in the research study. In addition, 100 community residents (CR) will be recruited into the study. Family members, friends and community residents do not participate in the Change Club, but may hear about Change Club activities in their community. |
| Group 2 (Control) | Experimental | Behavioral: Group 2 (Control)Control group participants will participate in no intervention activities during the 3-year research study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- We will be recruiting Change Club members (CCM), friend and family members (FFM) of CCM, and community residents (CR).
- Age 18-99
- English-speaking
- Provide consent electronically
- Be willing to be randomized to either group
Key exclusion criteria (5 listed)
- Cognitive impairment (if it precludes completion of assessments and/or intervention)
- Inability to communicate due to severe, uncorrectable hearing loss or speech disorder (if it precludes completion of assessments and/or intervention)
- Severe visual impairment (if it precludes completion of assessments and/or intervention)
- Inability to read (as it precludes completion of assessments and/or intervention)
- Already included in another study sample (e.g. CR cannot also be CCM)
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 |
|---|---|---|
| Group 1 (Intervention)The investigators will evaluate the efficacy of the CC curriculum in a 24-months community-based randomized controlled trial. They will compare changes in CVD-related anthropometric, behavioral, and psychosocial parameters between subjects in intervention and control communities. | Behavioural | Group 1 (Intervention) |
| Group 2 (Control)Group 2 will be offered the same activities as Group 1 after the conclusion of the research study. | Behavioural | Group 2 (Control) |
Primary outcome
Change in American Heart Association's Life's Simple 7 (LS7) cardiovascular health score
Time frame: Baseline to 24 months
American Heart Association's Life's Simple 7 (LS7) score is a composite of cardiovascular disease (CVD) risk factors (physical activity, eating habits, smoking status, cholesterol, glucose, body mass index (BMI), and blood pressure). Score ranges from 0 to 14. Higher scores indicate better health.
36 secondary outcomes
Change in body mass index (BMI)
Time frame: Baseline to 24 months
Change in waist circumference
Time frame: Baseline to 24 months
Percent with high/elevated blood pressure
Time frame: Baseline to 24 months
Percent with high/borderline high cholesterol.
Time frame: Baseline to 24 months
Percent with diabetes/prediabetes
Time frame: Baseline to 24 months
Change in general health status
Time frame: Baseline to 24 months
Current smoker (y/n)
Time frame: Baseline to 24 months
Change in total HEI score
Time frame: Baseline to 24 months
Change in fruit and vegetable intake
Time frame: Baseline to 24 months
Change in consumption of whole grains
Time frame: Baseline to 24 months
Change in fiber intake
Time frame: Baseline to 24 months
Met recommendation for fish consumption (y/n)
Time frame: Baseline to 24 months
Change in frequency of consuming ultra-processed foods
Time frame: Baseline to 24 months
Change in red and processed meat consumption
Time frame: Baseline to 24 months
Change in alcohol consumption
Time frame: Baseline to 24 months
Change in total steps per day
Time frame: Baseline to 24 months
Change in total physical activity
Time frame: Baseline to 24 months
Change in World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) recommendation adherence score
Time frame: Baseline to 24 months
Change in healthy eating motivation
Time frame: Baseline to 24 months
Change in confidence for healthy eating
Time frame: Baseline to 24 months
Change in social support for healthy eating
Time frame: Baseline to 24 months
Change in exercise attitudes
Time frame: Baseline to 24 months
Change in exercise confidence
Time frame: Baseline to 24 months
Change in social support for physical activity
Time frame: Baseline to 24 months
Change in social engagement
Time frame: Baseline to 24 months
Change in (community) social cohesion
Time frame: Baseline to 24 months
Change in individual mobilization
Time frame: Baseline to 24 months
Change in general civic engagement attitudes
Time frame: Baseline to 24 months
Change in general civic engagement behaviors
Time frame: Baseline to 24 months
Change in investment in community health
Time frame: Baseline to 24 months
Change in walking environment
Time frame: Baseline to 24 months
Change in neighborhood safety
Time frame: Baseline to 24 months
Change in neighborhood aesthetic
Time frame: Baseline to 24 months
Change in fresh fruit and vegetable availability
Time frame: Baseline to 24 months
Change in store selection motivation
Time frame: Baseline to 24 months
Change in restaurant healthy food availability
Time frame: Baseline to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Derived from this study: PubMed 42608888Seguin-Fowler RA, Graham ML, Eldridge GD, Folta SC, Szeszulski J, MacMillan Uribe AL, Marshall GA, Villarreal DL, Volpe LC, Maddock JE, Nelson ME. Implementation of and Recommendations From the Change Club Civic Engagement Curriculum Targeting Health Behavior Improvement. Am J Health Promot. 2026 Aug 17:8901171261478393. doi: 10.1177/08901171261478393. Online ahead of print.
- Derived from this study: PubMed 42465624Seguin-Fowler RA, Hanson KL, Eldridge GD, Marshall GA, Maddock JE, Folta SC, Villarreal DL, Graham ML. The Change Club intervention: 2-year impacts from a cluster-randomized trial in rural communities in New York and Texas. Front Public Health. 2026 Jul 2;14:1793324. doi: 10.3389/fpubh.2026.1793324. eCollection 2026.
- Derived from this study: PubMed 42174511Seguin-Fowler RA, Graham ML, Hanson KL, Villarreal DL, Eldridge GD, Christou A, On A, Kershaw M, Folta SC, Maddock JE, Andreyeva E. Effective and cost-effective strategies for recruiting rural adults into a civic engagement and health behavior change research study. BMC Public Health. 2026 May 22;26(1):2179. doi: 10.1186/s12889-026-27592-x.
- Derived from this study: PubMed 41918127Graham ML, Lewis EC, Villarreal DL, Folta SC, Volpe LC, Eldridge GD, Hanson KL, Marshall GA, Maddock JE, Nelson ME, Seguin-Fowler RA. Implementation of Change Club action plans to promote built environment change in rural communities. Int J Behav Nutr Phys Act. 2026 Mar 31;23(1):49. doi: 10.1186/s12966-026-01908-x.
- Derived from this study: PubMed 40385265Graham ML, Eldridge GD, Demment M, Kershaw M, Christou A, Luong V, Andreyeva E, Folta SC, Hanson KL, Maddock JE, Seguin-Fowler RA. Leadership Characteristics of Extension Agents Facilitating a Healthy Communities, Civic-Engagement Randomized Trial in Rural Towns. J Healthy Eat Act Living. 2024 Dec 1;4(3):174-188. eCollection 2024.
- Derived from this study: PubMed 36058913Seguin-Fowler RA, Hanson KL, Villarreal D, Rethorst CD, Ayine P, Folta SC, Maddock JE, Patterson MS, Marshall GA, Volpe LC, Eldridge GD, Kershaw M, Luong V, Wang H, Kenkel D. Evaluation of a civic engagement approach to catalyze built environment change and promote healthy eating and physical activity among rural residents: a cluster (community) randomized controlled trial. BMC Public Health. 2022 Sep 4;22(1):1674. doi: 10.1186/s12889-022-13653-4.
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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. This study is not recruiting at the moment.
Rebecca A. Seguin-Fowler, PhD principal investigator
Texas A&M AgriLife Research
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 (Intervention) in people with Heart Diseases, run by Texas A&M University at 13 sites 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 15 inclusion and 5 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: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in American Heart Association's Life's Simple 7 (LS7) cardiovascular health score (time frame: Baseline to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05002660, which also lists 6 linked publications.
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 18 Aug 2026.