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

Heart Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05002660
• Other study ID #: R01CA230738
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 3, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2023
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2831
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Behavioral:
• Group 1 (Intervention)
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)
Group 2 will be offered the same activities as Group 1 after the conclusion of the research study.

Locations

Country	Name	City	State
United States	Camden and surrounding towns	Camden	New York
United States	Canastota	Canastota	New York
United States	Carthage and surrounding towns	Carthage	New York
United States	Center and Shelbyville	Center	Texas
United States	Groveton and Woodlake	Groveton	Texas
United States	Hamilton and surrounding towns	Hamilton	New York
United States	Littlefield and surrounding towns	Littlefield	Texas
United States	Marshall	Marshall	Texas
United States	Plainview	Plainview	Texas
United States	Rome	Rome	New York
United States	Hounsfield and surrounding towns	Sackets Harbor	New York
United States	Trinity	Trinity	Texas
United States	Watertown	Watertown	New York

Sponsors (3)

Lead Sponsor	Collaborator
Texas A&M University	Cornell University, Tufts University

Country where clinical trial is conducted

United States, 

Outcome

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