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

N/AActive Not RecruitingNCT05002660

Texas A&M University2,420 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

2,420

Conditions

Heart Diseases

Interventions

Group 1 (Intervention)BEHAVIORAL

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)BEHAVIORAL

Group 2 will be offered the same activities as Group 1 after the conclusion of the research study.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (13)

Camden and surrounding towns

Camden, New York, United States

Canastota

Canastota, New York, United States

Carthage and surrounding towns

Carthage, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 24 months

Secondary Outcomes

Change in body mass index (BMI)

Height and weight will be self-measured and BMI will be calculated.

Time frame: Baseline to 24 months

Change in waist circumference

Waist circumference (cm(in)) will be self-measured.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to 24 months

Percent with diabetes/prediabetes

Percent with diabetes/ prediabetes will be classified from self-reported measurements, diagnosis, and medication use.

Time frame: 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.

Data from ClinicalTrials.gov

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Hamilton and surrounding towns

Hamilton, New York, United States

Rome

Rome, New York, United States

Hounsfield and surrounding towns

Sackets Harbor, New York, United States

Watertown

Watertown, New York, United States

Center and Shelbyville

Center, Texas, United States

Groveton and Woodlake

Groveton, Texas, United States

Littlefield and surrounding towns

Littlefield, Texas, United States

...and 3 more locations

Time frame: Baseline to 24 months

Current smoker (y/n)

Whether or not a participant currently smokes will be assessed using an LS7 item.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to 24 months