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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Diseases

Intervention / Treatment
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* Behavioral: Group 1 (Intervention)
* Behavioral: Group 2 (Control)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Community-based cluster randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (Intervention)<br>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. | Behavioral: Group 1 (Intervention)<br>* 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.<br>|
| Experimental: Group 2 (Control)<br>Control group participants will participate in no intervention activities during the 3-year research study. | Behavioral: Group 2 (Control)<br>* Group 2 will be offered the same activities as Group 1 after the conclusion of the research study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body mass index (BMI) | Height and weight will be self-measured and BMI will be calculated. | Baseline to 24 months | 
| Change in waist circumference | Waist circumference (cm(in)) will be self-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. | 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. | Baseline to 24 months | 
| Percent with diabetes/prediabetes | Percent with diabetes/ prediabetes will be classified from self-reported measurements, diagnosis, and medication use. | 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. | Baseline to 24 months | 
| Current smoker (y/n) | Whether or not a participant currently smokes will be assessed using an LS7 item. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, Built Environment, Eating Habits