Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT05002660
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-30
First Post:
2021-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Change Club Study: Evaluation of Civic Engagement for Built Environment Change and Health Improvement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001522', 'term': 'Behavior, Animal'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Community-based cluster randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2420}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2021-08-04', 'studyFirstSubmitQcDate': '2021-08-04', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in American Heart Association's Life's Simple 7 (LS7) cardiovascular health score", 'timeFrame': 'Baseline to 24 months', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Change in body mass index (BMI)', 'timeFrame': 'Baseline to 24 months', 'description': 'Height and weight will be self-measured and BMI will be calculated.'}, {'measure': 'Change in waist circumference', 'timeFrame': 'Baseline to 24 months', 'description': 'Waist circumference (cm(in)) will be self-measured.'}, {'measure': 'Percent with high/elevated blood pressure', 'timeFrame': 'Baseline to 24 months', 'description': 'Percent with high/elevated blood pressure will be classified from self-reported measurements, diagnosis, and medication use.'}, {'measure': 'Percent with high/borderline high cholesterol.', 'timeFrame': 'Baseline to 24 months', 'description': 'Percent with high/borderline high cholesterol will be classified from self-reported measurements, diagnosis, and medication use.'}, {'measure': 'Percent with diabetes/prediabetes', 'timeFrame': 'Baseline to 24 months', 'description': 'Percent with diabetes/ prediabetes will be classified from self-reported measurements, diagnosis, and medication use.'}, {'measure': 'Change in general health status', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Current smoker (y/n)', 'timeFrame': 'Baseline to 24 months', 'description': 'Whether or not a participant currently smokes will be assessed using an LS7 item.'}, {'measure': 'Change in total HEI score', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Change in fruit and vegetable intake', 'timeFrame': 'Baseline to 24 months', 'description': 'Total fruit and vegetable intake (cups/day) will be measured using a LS7 item and a 24-hour recall.'}, {'measure': 'Change in consumption of whole grains', 'timeFrame': 'Baseline to 24 months', 'description': 'Whole grain consumption (servings/day) will be assessed using an LS7 item and a 24-hour recall.'}, {'measure': 'Change in fiber intake', 'timeFrame': 'Baseline to 24 months', 'description': 'Fiber intake (g/day) will be assessed using the NHANES Dietary Screener Questionnaire (DSQ) and a 24-hour recall.'}, {'measure': 'Met recommendation for fish consumption (y/n)', 'timeFrame': 'Baseline to 24 months', 'description': 'Whether or not a participant met the recommendation for fish consumption will be assessed using an LS7 item.'}, {'measure': 'Change in frequency of consuming ultra-processed foods', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Change in red and processed meat consumption', 'timeFrame': 'Baseline to 24 months', 'description': 'Total red and processed meat consumption (g/week) will be estimated using the DSQ and a 24-hour recall.'}, {'measure': 'Change in alcohol consumption', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Change in total steps per day', 'timeFrame': 'Baseline to 24 months', 'description': 'Total steps per day will be calculated using the average of self-reported pedometer or wearable fitness tracker readings.'}, {'measure': 'Change in total physical activity', 'timeFrame': 'Baseline to 24 months', 'description': 'Total physical activity (MET-min/wk) will be assessed using the International Physical Activity Questionnaire long form (IPAQ-long).'}, {'measure': 'Change in World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) recommendation adherence score', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Change in healthy eating motivation', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Change in confidence for healthy eating', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Change in social support for healthy eating', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Change in exercise attitudes', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Change in exercise confidence', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Change in social support for physical activity', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Change in social engagement', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Change in (community) social cohesion', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Change in individual mobilization', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Change in general civic engagement attitudes', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Change in general civic engagement behaviors', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Change in investment in community health', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Change in walking environment', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Change in neighborhood safety', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Change in neighborhood aesthetic', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Change in fresh fruit and vegetable availability', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Change in store selection motivation', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}, {'measure': 'Change in restaurant healthy food availability', 'timeFrame': 'Baseline to 24 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical Activity', 'Built Environment', 'Eating Habits'], 'conditions': ['Heart Diseases']}, 'referencesModule': {'references': [{'pmid': '40385265', 'type': 'DERIVED', 'citation': 'Graham ML, Eldridge GD, Demment M, Kershaw M, Christou A, Luong V, Andreyeva E, Folta SC, Hanson KL, Maddock JE, Seguin-Fowler RA. Leadership Characteristics of Extension Agents Facilitating a Healthy Communities, Civic-Engagement Randomized Trial in Rural Towns. J Healthy Eat Act Living. 2024 Dec 1;4(3):174-188. eCollection 2024.'}, {'pmid': '36058913', 'type': 'DERIVED', 'citation': 'Seguin-Fowler RA, Hanson KL, Villarreal D, Rethorst CD, Ayine P, Folta SC, Maddock JE, Patterson MS, Marshall GA, Volpe LC, Eldridge GD, Kershaw M, Luong V, Wang H, Kenkel D. Evaluation of a civic engagement approach to catalyze built environment change and promote healthy eating and physical activity among rural residents: a cluster (community) randomized controlled trial. BMC Public Health. 2022 Sep 4;22(1):1674. doi: 10.1186/s12889-022-13653-4.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWe will be recruiting Change Club members (CCM), friend and family members (FFM) of CCM, and community residents (CR).\n\nCommon inclusion criteria include:\n\n* Age 18-99\n* English-speaking\n\nCCM also must:\n\n* Provide consent electronically\n* Be willing to be randomized to either group\n* Score "poor" or "intermediate" on at least one of the Simple 7 composite score items (e.g. not meeting Physical Activity Guidelines for Americans)\n* Live in one of the designated towns in NY and TX\n\nFFM also must:\n\n* Provide consent electronically\n* Be family members or friends identified by a CCM\n\nCR also must:\n\n* Provide consent electronically\n* Live in one of the designated towns in NY and TX\n\nExclusion Criteria:\n\n* Cognitive impairment (if it precludes completion of assessments and/or intervention)\n* Inability to communicate due to severe, uncorrectable hearing loss or speech disorder (if it precludes completion of assessments and/or intervention)\n* Severe visual impairment (if it precludes completion of assessments and/or intervention)\n* Inability to read (as it precludes completion of assessments and/or intervention)\n* Already included in another study sample (e.g. CR cannot also be CCM)'}, 'identificationModule': {'nctId': 'NCT05002660', 'briefTitle': 'The Change Club Study: Evaluation of Civic Engagement for Built Environment Change and Health Improvement', 'organization': {'class': 'OTHER', 'fullName': 'Texas A&M University'}, 'officialTitle': 'Evaluation of a Civic Engagement Approach to Catalyze Built Environment Change and Promote Healthy Eating and Physical Activity Among Rural Residents', 'orgStudyIdInfo': {'id': 'R01CA230738', 'link': 'https://reporter.nih.gov/quickSearch/R01CA230738', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (Intervention)', '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.\n\nIn 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.', 'interventionNames': ['Behavioral: Group 1 (Intervention)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (Control)', 'description': 'Control group participants will participate in no intervention activities during the 3-year research study.', 'interventionNames': ['Behavioral: Group 2 (Control)']}], 'interventions': [{'name': 'Group 1 (Intervention)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Group 1 (Intervention)']}, {'name': 'Group 2 (Control)', 'type': 'BEHAVIORAL', 'description': 'Group 2 will be offered the same activities as Group 1 after the conclusion of the research study.', 'armGroupLabels': ['Group 2 (Control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13316', 'city': 'Camden', 'state': 'New York', 'country': 'United States', 'facility': 'Camden and surrounding towns', 'geoPoint': {'lat': 43.33451, 'lon': -75.74796}}, {'zip': '13032', 'city': 'Canastota', 'state': 'New York', 'country': 'United States', 'facility': 'Canastota', 'geoPoint': {'lat': 43.07951, 'lon': -75.75074}}, {'zip': '13619', 'city': 'Carthage', 'state': 'New York', 'country': 'United States', 'facility': 'Carthage and surrounding towns', 'geoPoint': {'lat': 43.97812, 'lon': -75.60936}}, {'zip': '13346,13355,13334,13310,13402', 'city': 'Hamilton', 'state': 'New York', 'country': 'United States', 'facility': 'Hamilton and surrounding towns', 'geoPoint': {'lat': 42.82701, 'lon': -75.54462}}, {'zip': '13308, 13440-2, 13449, 13478', 'city': 'Rome', 'state': 'New York', 'country': 'United States', 'facility': 'Rome', 'geoPoint': {'lat': 43.21285, 'lon': -75.45573}}, {'zip': '13685', 'city': 'Sackets Harbor', 'state': 'New York', 'country': 'United States', 'facility': 'Hounsfield and surrounding towns', 'geoPoint': {'lat': 43.94617, 'lon': -76.11909}}, {'zip': '13601, 13602, 13603', 'city': 'Watertown', 'state': 'New York', 'country': 'United States', 'facility': 'Watertown', 'geoPoint': {'lat': 43.97478, 'lon': -75.91076}}, {'zip': '75973, 75935', 'city': 'Center', 'state': 'Texas', 'country': 'United States', 'facility': 'Center and Shelbyville', 'geoPoint': {'lat': 31.51073, 'lon': -96.4247}}, {'zip': '75845, 75865', 'city': 'Groveton', 'state': 'Texas', 'country': 'United States', 'facility': 'Groveton and Woodlake', 'geoPoint': {'lat': 31.05491, 'lon': -95.12577}}, {'zip': '79339', 'city': 'Littlefield', 'state': 'Texas', 'country': 'United States', 'facility': 'Littlefield and surrounding towns', 'geoPoint': {'lat': 33.91731, 'lon': -102.3249}}, {'zip': '75670, 75671, 75672', 'city': 'Marshall', 'state': 'Texas', 'country': 'United States', 'facility': 'Marshall', 'geoPoint': {'lat': 32.54487, 'lon': -94.36742}}, {'zip': '79072, 79073', 'city': 'Plainview', 'state': 'Texas', 'country': 'United States', 'facility': 'Plainview', 'geoPoint': {'lat': 34.18479, 'lon': -101.70684}}, {'zip': '75862', 'city': 'Trinity', 'state': 'Texas', 'country': 'United States', 'facility': 'Trinity', 'geoPoint': {'lat': 30.94519, 'lon': -95.3755}}], 'overallOfficials': [{'name': 'Rebecca A. Seguin-Fowler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas A&M AgriLife Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas A&M University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cornell University', 'class': 'OTHER'}, {'name': 'Tufts University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}