The Change Club Study: Evaluation of Civic Engagement for Built Environment Change and Health Improvement

Texas A&M University

Status: Active, not recruiting

Conditions: Heart Diseases

Treatments: Behavioral: Group 2 (Control); Behavioral: Group 1 (Intervention)

Study type: Interventional

Funder types: Other

Identifiers

NCT05002660

R01CA230738

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,420 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,420 participants in 2 patient groups

Group 1 (Intervention)

Experimental group

Description:

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.

Treatment:

Behavioral: Group 1 (Intervention)

Group 2 (Control)

Experimental group

Description:

Control group participants will participate in no intervention activities during the 3-year research study.

Treatment:

Behavioral: Group 2 (Control)