The Change Club Study: Evaluation of Civic Engagement for Built Environment Change and Health Improvement
Evaluation of a Civic Engagement Approach to Catalyze Built Environment Change and Promote Healthy Eating and Physical Activity Among Rural Residents
1 other identifier
interventional
2,420
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Typical duration for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2021
CompletedFirst Posted
Study publicly available on registry
August 12, 2021
CompletedStudy Start
First participant enrolled
May 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
October 30, 2025
October 1, 2025
3.2 years
August 4, 2021
October 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Baseline to 24 months
Secondary Outcomes (36)
Change in body mass index (BMI)
Baseline to 24 months
Change in waist circumference
Baseline to 24 months
Percent with high/elevated blood pressure
Baseline to 24 months
Percent with high/borderline high cholesterol.
Baseline to 24 months
Percent with diabetes/prediabetes
Baseline to 24 months
- +31 more secondary outcomes
Study Arms (2)
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.
Group 2 (Control)
EXPERIMENTALControl group participants will participate in no intervention activities during the 3-year research study.
Interventions
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 will be offered the same activities as Group 1 after the conclusion of the research study.
Eligibility Criteria
You may qualify if:
- We will be recruiting Change Club members (CCM), friend and family members (FFM) of CCM, and community residents (CR).
- Age 18-99
- English-speaking
- CCM also must:
- Provide consent electronically
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Texas A&M Universitylead
- Cornell Universitycollaborator
- Tufts Universitycollaborator
Study Sites (13)
Camden and surrounding towns
Camden, New York, 13316, United States
Canastota
Canastota, New York, 13032, United States
Carthage and surrounding towns
Carthage, New York, 13619, United States
Hamilton and surrounding towns
Hamilton, New York, 13346,13355,13334,13310,13402, United States
Rome
Rome, New York, 13308, 13440-2, 13449, 13478, United States
Hounsfield and surrounding towns
Sackets Harbor, New York, 13685, United States
Watertown
Watertown, New York, 13601, 13602, 13603, United States
Center and Shelbyville
Center, Texas, 75973, 75935, United States
Groveton and Woodlake
Groveton, Texas, 75845, 75865, United States
Littlefield and surrounding towns
Littlefield, Texas, 79339, United States
Marshall
Marshall, Texas, 75670, 75671, 75672, United States
Plainview
Plainview, Texas, 79072, 79073, United States
Trinity
Trinity, Texas, 75862, United States
Related Publications (2)
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.
PMID: 40385265DERIVEDSeguin-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.
PMID: 36058913DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca A. Seguin-Fowler, PhD
Texas A&M AgriLife Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2021
First Posted
August 12, 2021
Study Start
May 3, 2023
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
October 30, 2025
Record last verified: 2025-10