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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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)
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

Other trials in United States

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 groups in NCT05002660
Study groupRoleWhat they receive
Group 1 (Intervention)ExperimentalFor 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)ExperimentalControl 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.

  1. 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)
  1. Change in body mass index (BMI)

    Height and weight will be self-measured and BMI will be calculated.

    Measured: Baseline to 24 months

  2. Change in waist circumference

    Waist circumference (cm(in)) will be self-measured.

    Measured: Baseline to 24 months

  3. 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

  4. 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

  5. Percent with diabetes/prediabetes

    Percent with diabetes/ prediabetes will be classified from self-reported measurements, diagnosis, and medication use.

    Measured: Baseline to 24 months

  6. 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

  7. Current smoker (y/n)

    Whether or not a participant currently smokes will be assessed using an LS7 item.

    Measured: Baseline to 24 months

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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.

  1. First posted12 Aug 2021
  2. Study start3 May 2023
  3. Primary completion23 Apr 2026
  4. Study completion23 Apr 2026

Resources

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)
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 42608888
  • Seguin-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 42465624
  • Seguin-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 42174511
  • Graham 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 41918127
  • Graham 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 40385265
  • Seguin-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

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.

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