Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-25 @ 2:29 PM
Study NCT ID:
NCT02868866
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2016-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dissemination and Implementation of Faith, Activity, and Nutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009752', 'term': 'Nutritional Status'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1807}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2016-07-12', 'studyFirstSubmitQcDate': '2016-08-11', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Church environment', 'timeFrame': '12 months', 'description': 'Church environmental factors that impede or promote physical activity and healthy eating, assessed through staff observations (only for phase 1 of study)'}], 'primaryOutcomes': [{'measure': 'Adoption', 'timeFrame': '12 months', 'description': '(# of eligible churches that are trained / # of eligible churches)\\*100'}, {'measure': 'Reach', 'timeFrame': '12 months', 'description': '(# of church members in trained churches / # of members of all eligible churches)\\*100'}, {'measure': 'Implementation fidelity', 'timeFrame': '12 months', 'description': 'Composite score consisting of implementation of core elements of the intervention'}, {'measure': 'Maintenance', 'timeFrame': '24 months', 'description': 'organization maintenance of the intervention based on leader reports'}], 'secondaryOutcomes': [{'measure': 'physical activity', 'timeFrame': '12 months', 'description': 'Self-reported proportion of members meeting physical activity recommendations using (only for phase 1 of study)'}, {'measure': 'fruit and vegetable intake', 'timeFrame': '12 months', 'description': 'Self-reported cups per day of fruits and vegetables (only for phase 1 of study)'}, {'measure': 'Self-efficacy for physical activity', 'timeFrame': '12 months', 'description': 'Self-reported self-efficacy for physical activity (average of scale items) (only for phase 1 of study)'}, {'measure': 'Self-efficacy for fruit and vegetable intake', 'timeFrame': '12 months', 'description': 'Self-reported self-efficacy for fruit and vegetable intake (average of scale items) (only for phase 1 of study)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['physical activity', 'nutrition', 'fruits and vegetables', 'faith-based', 'churches'], 'conditions': ['Physical Activity, Healthy Eating']}, 'referencesModule': {'references': [{'pmid': '35236373', 'type': 'DERIVED', 'citation': 'Wilcox S, Day KR, Saunders RP, Jake-Schoffman DE, Kaczynski AT, Stucker J, Dunn CG, Bernhart JA. The Faith, Activity, and Nutrition (FAN) dissemination and implementation study: changes in and maintenance of organizational practices over 24 months in a statewide initiative. Int J Behav Nutr Phys Act. 2022 Mar 2;19(1):23. doi: 10.1186/s12966-022-01253-9.'}, {'pmid': '32528919', 'type': 'DERIVED', 'citation': 'Wilcox S, Saunders RP, Jake-Schoffman D, Hutto B. The Faith, Activity, and Nutrition (FAN) Dissemination and Implementation Study: 24-Month Organizational Maintenance in a Countywide Initiative. Front Public Health. 2020 May 14;8:171. doi: 10.3389/fpubh.2020.00171. eCollection 2020.'}, {'pmid': '29656913', 'type': 'DERIVED', 'citation': 'Wilcox S, Saunders RP, Kaczynski AT, Forthofer M, Sharpe PA, Goodwin C, Condrasky M, Kennedy VL Sr, Jake-Schoffman DE, Kinnard D, Hutto B. Faith, Activity, and Nutrition Randomized Dissemination and Implementation Study: Countywide Adoption, Reach, and Effectiveness. Am J Prev Med. 2018 Jun;54(6):776-785. doi: 10.1016/j.amepre.2018.02.018. Epub 2018 Apr 12.'}]}, 'descriptionModule': {'briefSummary': 'This dissemination and implementation study will examine the impact of the Faith, Activity, and Nutrition (FAN) program on both church practices and member behaviors in both a countywide (randomized trial) and statewide (quasi-experimental) study. Guided by two theoretical frameworks, the specific aims of the applied research project are to: 1) examine the adoption and reach of FAN in churches and organizational factors associated with adoption; 2) characterize implementation fidelity and multilevel factors associated with implementation; 3) describe organizational maintenance of FAN and factors associated with maintenance; and 4) study the effectiveness of FAN.', 'detailedDescription': "The USC PRC's applied research project will study the dissemination and implementation of an evidence-based program shown previously to significantly increase physical activity and fruit and vegetable intake in churches in South Carolina (Faith, Activity, and Nutrition; FAN). Guided by two theoretical frameworks, the specific aims of the applied research project are to: 1) examine the adoption and reach of FAN in churches and organizational factors associated with adoption; 2) characterize implementation fidelity and multilevel factors associated with implementation; 3) describe organizational maintenance of FAN and factors associated with maintenance; and 4) study the effectiveness of FAN. In Phase 1, churches in a rural county with a high proportion of African American residents will be randomized to receive training in FAN from a community health advisor (n=40) or to be part of a delayed intervention control group (n=20). In Phase 2, a quasi-experimental study will be done with a large religious denomination in SC (churches are not randomized)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Phase 1 churches: church in Fairfield County, SC with at least 20 members who regularly attend worship service\n* Phase 2 churches: church in the SC Conference of the United Methodist Church\n* Members (phase 1): adult who regularly attends church participating in the study\n\nExclusion Criteria:\n\n* Members (phase 1): under the age of 18\n* Members (phase 1): does not regularly attend church participating in the study'}, 'identificationModule': {'nctId': 'NCT02868866', 'briefTitle': 'Dissemination and Implementation of Faith, Activity, and Nutrition', 'organization': {'class': 'OTHER', 'fullName': 'University of South Carolina'}, 'officialTitle': 'Faith, Activity, and Nutrition: Dissemination in Underserved Communities', 'orgStudyIdInfo': {'id': 'Pro00036222'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate intervention', 'description': 'Training of church committee followed by 12 months of technical assistance phone calls.', 'interventionNames': ['Behavioral: Immediate Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Delayed intervention', 'description': '20 churches are followed but receive no intervention.'}], 'interventions': [{'name': 'Immediate Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Faith, Activity, and Nutrition'], 'description': "Committees from 40 churches will be trained in the Faith, Activity, and Nutrition program by Community Health Advisors. The training focuses on helping churches create healthier church environments for physical activity and healthy eating using Cohen's structural model of health behavior as a guide. Each church committee participates in a full-day training and submits a program plan and budget. Churches receive materials to support implementation of the program. After the full-day training, trained churches receive 12 monthly technical assistance calls to help them implement their program plan. The church coordinator receives 8 calls and the pastor receives 4 calls over the 12 months. In Phase 2, the intervention is open to any church in the SC Conference of the United Methodist Church.", 'armGroupLabels': ['Immediate intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29634', 'city': 'Clemson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Clemson University', 'geoPoint': {'lat': 34.68344, 'lon': -82.83737}}, {'zip': '29208', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'University of South Carolina', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '29180', 'city': 'Winnsboro', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Fairfield Behavioral Health Services', 'geoPoint': {'lat': 34.3807, 'lon': -81.08648}}], 'overallOfficials': [{'name': 'Sara J Wilcox, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sara Wilcox', 'investigatorAffiliation': 'University of South Carolina'}}}}