Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-01-01 @ 4:09 AM
Study NCT ID:
NCT04042493
Status:
COMPLETED
Last Update Posted:
2023-03-22
First Post:
2019-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Connect for Health Pediatric Weight Management Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006262', 'term': 'Health'}], 'ancestors': [{'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "The Connect for Health program is a package of practice-level care enhancements to systematically improve the quality of clinical care provided for childhood obesity and offer support directly to parents to improve the children's growth trajectories."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19304}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2019-07-31', 'studyFirstSubmitQcDate': '2019-07-31', 'lastUpdatePostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in child Body Mass Index', 'timeFrame': 'One year', 'description': 'Age- and sex-specific Body Mass Index z-score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Overweight', 'Obesity', 'Pediatric', 'Implementation', 'Dissemination'], 'conditions': ['Overweight and Obesity', 'Severe Obesity']}, 'referencesModule': {'references': [{'pmid': '37974245', 'type': 'DERIVED', 'citation': 'Simione M, Aschbrenner K, Farrar-Muir H, Luo M, Granadeno J, Caballero-Gonzalez A, Price SN, Torres C, Boudreau AA, Fiechtner L, Hambidge SJ, Sease K, Taveras EM. Adapting Connect for Health pediatric weight management program for telehealth in response to the COVID-19 pandemic. Implement Sci Commun. 2023 Nov 16;4(1):139. doi: 10.1186/s43058-023-00523-2.'}, {'pmid': '34024120', 'type': 'DERIVED', 'citation': 'Simione M, Farrar-Muir H, Mini FN, Perkins ME, Luo M, Frost H, Orav EJ, Metlay J, Zai AH, Kistin CJ, Sease K, Hambidge SJ, Taveras EM; Connect for Health Collaborative. Implementation of the Connect for Health pediatric weight management program: study protocol and baseline characteristics. J Comp Eff Res. 2021 Aug;10(11):881-892. doi: 10.2217/cer-2021-0076. Epub 2021 May 24.'}, {'pmid': '32885211', 'type': 'DERIVED', 'citation': 'Simione M, Frost HM, Cournoyer R, Mini FN, Cassidy J, Craddock C, Moreland J, Wallace J, Metlay J, Kistin CJ, Sease K, Hambidge SJ, Taveras EM. Engaging stakeholders in the adaptation of the Connect for Health pediatric weight management program for national implementation. Implement Sci Commun. 2020 Jun 17;1:55. doi: 10.1186/s43058-020-00047-z. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The overall aim of this study is to disseminate the evidence-based Connect for Health program, specifically targeting pediatric primary care practices that deliver care to low-income children in the US who have a disproportionately high prevalence of childhood obesity and evaluate the effectiveness of the program implementation and dissemination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children receiving primary care at the participating health centers across the three health systems'}, 'identificationModule': {'nctId': 'NCT04042493', 'briefTitle': 'Connect for Health Pediatric Weight Management Program', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Dissemination and Implementation of Effective Childhood Obesity Treatment Innovations', 'orgStudyIdInfo': {'id': '2018P002972'}, 'secondaryIdInfos': [{'id': 'DI-2017C3-9005', 'type': 'OTHER_GRANT', 'domain': 'PCORI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Connect for Health Program', 'interventionNames': ['Behavioral: Connect for Health']}], 'interventions': [{'name': 'Connect for Health', 'type': 'BEHAVIORAL', 'description': 'The program includes (1) electronic health record (EHR)-based clinical decision support tools to guide pediatric providers in child weight management; (2) clinician and medical staff training in obesity management best practices, (3) family educational materials focused on evidence-based behavioral targets; and (4) social- and community-informed text messages for parents to support behavior change.', 'armGroupLabels': ['Connect for Health Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Health and Hospital Authority', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Health System / Prisma Health', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}], 'overallOfficials': [{'name': 'Elsie Taveras, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Denver Health and Hospital Authority', 'class': 'OTHER'}, {'name': 'Prisma Health-Upstate', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Division of General Academic Pediatrics', 'investigatorFullName': 'Elsie Taveras, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}