Clinical trial NCT05002660: The Change Club Study: Evaluation of Civic Engagement for Built Environment Change and Health Improvement
Official title: The Change Club Study: Evaluation of Civic Engagement for Built Environment Change and Health Improvement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Diseases
Keywords: Physical Activity
Built Environment
Eating Habits
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: Cornell University
name: Tufts University
First posted: 2021-08-12
Enrollment: 2420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Community-based cluster randomized controlled trial
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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
* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in American Heart Association's Life's Simple 7 (LS7) cardiovascular health score
timeFrame: Baseline to 24 months
Secondary outcomes:
measure: Change in body mass index (BMI)
timeFrame: Baseline to 24 months
measure: Change in waist circumference
timeFrame: Baseline to 24 months
measure: Percent with high/elevated blood pressure
timeFrame: Baseline to 24 months
measure: Percent with high/borderline high cholesterol.
timeFrame: Baseline to 24 months
measure: Percent with diabetes/prediabetes
timeFrame: Baseline to 24 months
measure: Change in general health status
timeFrame: Baseline to 24 months
measure: Current smoker (y/n)
timeFrame: Baseline to 24 months
measure: Change in total HEI score
timeFrame: Baseline to 24 months
measure: Change in fruit and vegetable intake
timeFrame: Baseline to 24 months
measure: Change in consumption of whole grains
timeFrame: Baseline to 24 months
measure: Change in fiber intake
timeFrame: Baseline to 24 months
measure: Met recommendation for fish consumption (y/n)
timeFrame: Baseline to 24 months
measure: Change in frequency of consuming ultra-processed foods
timeFrame: Baseline to 24 months
measure: Change in red and processed meat consumption
timeFrame: Baseline to 24 months
measure: Change in alcohol consumption
timeFrame: Baseline to 24 months
measure: Change in total steps per day
timeFrame: Baseline to 24 months
measure: Change in total physical activity
timeFrame: Baseline to 24 months
measure: Change in World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) recommendation adherence score
timeFrame: Baseline to 24 months
measure: Change in healthy eating motivation
timeFrame: Baseline to 24 months
measure: Change in confidence for healthy eating
timeFrame: Baseline to 24 months
measure: Change in social support for healthy eating
timeFrame: Baseline to 24 months
measure: Change in exercise attitudes
timeFrame: Baseline to 24 months
measure: Change in exercise confidence
timeFrame: Baseline to 24 months
measure: Change in social support for physical activity
timeFrame: Baseline to 24 months
measure: Change in social engagement
timeFrame: Baseline to 24 months
measure: Change in (community) social cohesion
timeFrame: Baseline to 24 months
measure: Change in individual mobilization
timeFrame: Baseline to 24 months
measure: Change in general civic engagement attitudes
timeFrame: Baseline to 24 months
measure: Change in general civic engagement behaviors
timeFrame: Baseline to 24 months
measure: Change in investment in community health
timeFrame: Baseline to 24 months
measure: Change in walking environment
timeFrame: Baseline to 24 months
measure: Change in neighborhood safety
timeFrame: Baseline to 24 months
measure: Change in neighborhood aesthetic
timeFrame: Baseline to 24 months
measure: Change in fresh fruit and vegetable availability
timeFrame: Baseline to 24 months
measure: Change in store selection motivation
timeFrame: Baseline to 24 months
measure: Change in restaurant healthy food availability
timeFrame: Baseline to 24 months
Other outcomes:
Locations:
city: Camden
country: United States
facility: Camden and surrounding towns
state: New York
city: Canastota
country: United States
facility: Canastota
state: New York
city: Carthage
country: United States
facility: Carthage and surrounding towns
state: New York
city: Hamilton
country: United States
facility: Hamilton and surrounding towns
state: New York
city: Rome
country: United States
facility: Rome
state: New York
city: Sackets Harbor
country: United States
facility: Hounsfield and surrounding towns
state: New York
city: Watertown
country: United States
facility: Watertown
state: New York
city: Center
country: United States
facility: Center and Shelbyville
state: Texas
city: Groveton
country: United States
facility: Groveton and Woodlake
state: Texas
city: Littlefield
country: United States
facility: Littlefield and surrounding towns
state: Texas
city: Marshall
country: United States
facility: Marshall
state: Texas
city: Plainview
country: United States
facility: Plainview
state: Texas
city: Trinity
country: United States
facility: Trinity
state: Texas
Study officials:
affiliation: Texas A&M AgriLife Research
name: Rebecca A. Seguin-Fowler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.