- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05002660
The Change Club Study: Evaluation of Civic Engagement for Built Environment Change and Health Improvement
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Camden, New York, United States, 13316
- Camden and surrounding towns
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Canastota, New York, United States, 13032
- Canastota
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Carthage, New York, United States, 13619
- Carthage and surrounding towns
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Hamilton, New York, United States, 13346,13355,13334,13310,13402
- Hamilton and surrounding towns
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Rome, New York, United States, 13308, 13440-2, 13449, 13478
- Rome
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Sackets Harbor, New York, United States, 13685
- Hounsfield and surrounding towns
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Watertown, New York, United States, 13601, 13602, 13603
- Watertown
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Texas
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Center, Texas, United States, 75973, 75935
- Center and Shelbyville
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Groveton, Texas, United States, 75845, 75865
- Groveton and Woodlake
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Littlefield, Texas, United States, 79339
- Littlefield and surrounding towns
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Marshall, Texas, United States, 75670, 75671, 75672
- Marshall
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Plainview, Texas, United States, 79072, 79073
- Plainview
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Trinity, Texas, United States, 75862
- Trinity
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1 (Intervention)
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. |
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.
|
Experimental: Group 2 (Control)
Control group participants will participate in no intervention activities during the 3-year research study.
|
Group 2 will be offered the same activities as Group 1 after the conclusion of the research study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in American Heart Association's Life's Simple 7 (LS7) cardiovascular health score
Time Frame: Baseline to 24 months
|
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.
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Baseline to 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body mass index (BMI)
Time Frame: Baseline to 24 months
|
Height and weight will be self-measured and BMI will be calculated.
|
Baseline to 24 months
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Change in waist circumference
Time Frame: Baseline to 24 months
|
Waist circumference (cm(in)) will be self-measured.
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Baseline to 24 months
|
Percent with high/elevated blood pressure
Time Frame: Baseline to 24 months
|
Percent with high/elevated blood pressure will be classified from self-reported measurements, diagnosis, and medication use.
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Baseline to 24 months
|
Percent with high/borderline high cholesterol.
Time Frame: Baseline to 24 months
|
Percent with high/borderline high cholesterol will be classified from self-reported measurements, diagnosis, and medication use.
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Baseline to 24 months
|
Percent with diabetes/prediabetes
Time Frame: Baseline to 24 months
|
Percent with diabetes/ prediabetes will be classified from self-reported measurements, diagnosis, and medication use.
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Baseline to 24 months
|
Change in general health status
Time Frame: Baseline to 24 months
|
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)
Time Frame: Baseline to 24 months
|
Whether or not a participant currently smokes will be assessed using an LS7 item.
|
Baseline to 24 months
|
Change in total HEI score
Time Frame: Baseline to 24 months
|
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
Time Frame: Baseline to 24 months
|
Total fruit and vegetable intake (cups/day) will be measured using a LS7 item and a 24-hour recall.
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Baseline to 24 months
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Change in consumption of whole grains
Time Frame: Baseline to 24 months
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Whole grain consumption (servings/day) will be assessed using an LS7 item and a 24-hour recall.
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Baseline to 24 months
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Change in fiber intake
Time Frame: Baseline to 24 months
|
Fiber intake (g/day) will be assessed using the NHANES Dietary Screener Questionnaire (DSQ) and a 24-hour recall.
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Baseline to 24 months
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Met recommendation for fish consumption (y/n)
Time Frame: Baseline to 24 months
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Whether or not a participant met the recommendation for fish consumption will be assessed using an LS7 item.
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Baseline to 24 months
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Change in frequency of consuming ultra-processed foods
Time Frame: Baseline to 24 months
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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.
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Baseline to 24 months
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Change in red and processed meat consumption
Time Frame: Baseline to 24 months
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Total red and processed meat consumption (g/week) will be estimated using the DSQ and a 24-hour recall.
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Baseline to 24 months
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Change in alcohol consumption
Time Frame: Baseline to 24 months
|
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.
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Baseline to 24 months
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Change in total steps per day
Time Frame: Baseline to 24 months
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Total steps per day will be calculated using the average of self-reported pedometer or wearable fitness tracker readings.
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Baseline to 24 months
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Change in total physical activity
Time Frame: Baseline to 24 months
|
Total physical activity (MET-min/wk) will be assessed using the International Physical Activity Questionnaire long form (IPAQ-long).
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Baseline to 24 months
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Change in World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) recommendation adherence score
Time Frame: Baseline to 24 months
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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.
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Baseline to 24 months
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Change in healthy eating motivation
Time Frame: Baseline to 24 months
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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.
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Baseline to 24 months
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Change in confidence for healthy eating
Time Frame: Baseline to 24 months
|
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.
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Baseline to 24 months
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Change in social support for healthy eating
Time Frame: Baseline to 24 months
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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
Time Frame: Baseline to 24 months
|
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
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Change in exercise confidence
Time Frame: Baseline to 24 months
|
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.
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Baseline to 24 months
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Change in social support for physical activity
Time Frame: Baseline to 24 months
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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.
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Baseline to 24 months
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Change in social engagement
Time Frame: Baseline to 24 months
|
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.
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Baseline to 24 months
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Change in (community) social cohesion
Time Frame: Baseline to 24 months
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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.
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Baseline to 24 months
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Change in individual mobilization
Time Frame: Baseline to 24 months
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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.
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Baseline to 24 months
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Change in general civic engagement attitudes
Time Frame: Baseline to 24 months
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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.
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Baseline to 24 months
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Change in general civic engagement behaviors
Time Frame: Baseline to 24 months
|
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.
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Baseline to 24 months
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Change in investment in community health
Time Frame: Baseline to 24 months
|
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.
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Baseline to 24 months
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Change in walking environment
Time Frame: Baseline to 24 months
|
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.
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Baseline to 24 months
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Change in neighborhood safety
Time Frame: Baseline to 24 months
|
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.
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Baseline to 24 months
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Change in neighborhood aesthetic
Time Frame: Baseline to 24 months
|
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.
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Baseline to 24 months
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Change in fresh fruit and vegetable availability
Time Frame: Baseline to 24 months
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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.
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Baseline to 24 months
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Change in store selection motivation
Time Frame: Baseline to 24 months
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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.
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Baseline to 24 months
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Change in restaurant healthy food availability
Time Frame: Baseline to 24 months
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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.
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Baseline to 24 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rebecca A. Seguin-Fowler, PhD, Texas A&M AgriLife Research
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01CA230738 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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