Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-02 @ 4:32 AM
Study NCT ID:
NCT04042467
Status:
COMPLETED
Last Update Posted:
2025-10-16
First Post:
2019-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'filoteia.popescu@vumc.org', 'phone': '615-875-9083', 'title': 'Filoteia Popescu', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Some population groups were underrepresented or not represented (e.g., patients who did not prefer to speak English or Spanish). The study was unable to collect reliable data on web-based dashboard use, limiting the ability to evaluate which digital components of the Greenlight Plus intervention were associated with effectiveness. Anthropometric measures collected during clinical care may be susceptible to measurement error. However, annual training was implemented to minimize errors.'}}, 'adverseEventsModule': {'timeFrame': "Adverse event data were collected across the study's 2-year duration for each participant.", 'description': 'AE: Any unfavorable and unintended sign, symptom, laboratory abnormality, or disease associated with study participation.\n\nSAE: Is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in death or persistent or significant disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a participant.\n\nA study-related event follows a temporal sequence from participation and cannot be reasonably explained by other factors.', 'eventGroups': [{'id': 'EG000', 'title': 'Greenlight Plus', 'description': "Families will receive the Greenlight intervention plus a health information technology (HIT) intervention aimed at supporting family goal-setting and behavior change. This design allows us to determine if HIT and the asynchronous support it provides between well-child visits can promote additional behavior change and obesity prevention.\n\nGreenlight Plus: Families randomized to the Greenlight Plus arm will receive a HIT intervention starting at the newborn clinic visit. During the newborn visit, these families will receive basic instructions on how to access the Greenlight technology platform, which includes the iOTA text-messaging application and a website (usable on desktop or mobile platform). Families will receive text messages and goal-setting over the first 2 years of the child's life.\n\nGreenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials.", 'otherNumAtRisk': 898, 'deathsNumAtRisk': 898, 'otherNumAffected': 1, 'seriousNumAtRisk': 898, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Greenlight', 'description': 'During each of the recommended well child visits from 0-24 months, pediatric residents, trained in clear health communication skills and shared goal-setting, will use the Greenlight Toolkit of low literacy, age- specific, parent education booklets to promote healthy family behaviors and obesity prevention.\n\nGreenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials.', 'otherNumAtRisk': 902, 'deathsNumAtRisk': 902, 'otherNumAffected': 0, 'seriousNumAtRisk': 902, 'deathsNumAffected': 2, 'seriousNumAffected': 0}], 'otherEvents': [{'notes': 'Participant selected "yes" to an AE in a self-administered survey. Study team unable to reach participant for further info. Believed to be a misclick but unable to confirm. Case accepted by IRB with no requested changes to protocol.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 898, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 902, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Child Weight for Length Trajectory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Greenlight Plus', 'description': "Families will receive the Greenlight intervention plus a health information technology (HIT) intervention aimed at supporting family goal-setting and behavior change. This design allows us to determine if HIT and the asynchronous support it provides between well-child visits can promote additional behavior change and obesity prevention.\n\nGreenlight Plus: Families randomized to the Greenlight Plus arm will receive a HIT intervention starting at the newborn clinic visit. During the newborn visit, these families will receive basic instructions on how to access the Greenlight technology platform, which includes the iOTA text-messaging application and a website (usable on desktop or mobile platform). Families will receive text messages and goal-setting over the first 2 years of the child's life.\n\nGreenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials."}, {'id': 'OG001', 'title': 'Greenlight', 'description': 'During each of the recommended well child visits from 0-24 months, pediatric residents, trained in clear health communication skills and shared goal-setting, will use the Greenlight Toolkit of low literacy, age- specific, parent education booklets to promote healthy family behaviors and obesity prevention.\n\nGreenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials.'}], 'classes': [{'title': '1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': '2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': '4 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.8', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': '9 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '13.4', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': '15 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.5', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '13.8', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': '18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.9', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '14.2', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': '24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.8', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated intervention effect at 24 mo.', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '-0.09', 'pValueComment': 'The p-value was not adjusted for multiple comparisons, and the a priori threshold for statistical significance was 0.05.', 'estimateComment': 'The p-value is for the Wald test (4 DoF) evaluating whether the Greenlight Plus and Greenlight group trajectories were significantly different. The estimation parameter is the model-estimated intervention effect at 24 months (kg/m).', 'groupDescription': 'Linear mixed-effects model (random intercepts and slopes for clinics and participants within clinics). A priori adjustment for baseline variables: child birth weight and biological sex, race/ethnicity, health literacy, language, education, income, and food insecurity. Child age and birth weight were included using natural splines with 3 DoF.\n\nEffect evaluated using Wald test with a 2-sided, 0.05 significance level. Null hypothesis: Equal weight-for-length growth trajectories in the two groups.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test (4 DoF) of intervention main effect and 3 intervention by age interaction parameters equal 0 vs. alternative that at least one was not 0.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 months', 'description': 'The primary outcome was child weight for length (kg/m) trajectory over 2 years. Weight and length measurements were obtained during pediatric care visits and abstracted from the medical record.', 'unitOfMeasure': 'kg/m', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Follow-up outcome measures were not obtained for 3 Greenlight Plus participants and 1 Greenlight participant.\n\nNOTE: While the analysis included data from children (n=896) and their parents (n=896), the unit of analysis was the child. Therefore, the number of participants has been reported consistently across the Participant Flow, Baseline Characteristics, and Outcome Measures sections.'}, {'type': 'SECONDARY', 'title': 'Child BMI Z-score Trajectory', 'timeFrame': 'Baseline to 24 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Child Weight-for-length Z-score Trajectory', 'timeFrame': 'Baseline to 24 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Child Overweight and/or Obesity', 'timeFrame': 'at 24 months', 'description': 'Outcome defined by CDC or WHO standards', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Greenlight Plus', 'description': "Families will receive the Greenlight intervention plus a health information technology (HIT) intervention aimed at supporting family goal-setting and behavior change. This design allows us to determine if HIT and the asynchronous support it provides between well-child visits can promote additional behavior change and obesity prevention.\n\nGreenlight Plus: Families randomized to the Greenlight Plus arm will receive a HIT intervention starting at the newborn clinic visit. During the newborn visit, these families will receive basic instructions on how to access the Greenlight technology platform, which includes the iOTA text-messaging application and a website (usable on desktop or mobile platform). Families will receive text messages and goal-setting over the first 2 years of the child's life.\n\nGreenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials."}, {'id': 'FG001', 'title': 'Greenlight', 'description': 'During each of the recommended well child visits from 0-24 months, pediatric residents, trained in clear health communication skills and shared goal-setting, will use the Greenlight Toolkit of low literacy, age- specific, parent education booklets to promote healthy family behaviors and obesity prevention.\n\nGreenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'The numbers reported in the table represent dyads (child and parent). The number of individual participants in the Greenlight Plus group was n=898 (449 children and 449 parents), and the number of individual participants in the Greenlight group was n=902 (451 children and 451 parents).', 'achievements': [{'groupId': 'FG000', 'numSubjects': '449'}, {'groupId': 'FG001', 'numSubjects': '451'}]}, {'type': 'COMPLETED', 'comment': 'The numbers reported in the table represent dyads (child and parent). The number of individual participants who completed the study in the Greenlight Plus group was n=770 (385 children and 385 parents), and the number of individual participants who completed the study in the Greenlight group was n=784 (392 children and 392 parents)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '385'}, {'groupId': 'FG001', 'numSubjects': '392'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '59'}]}]}], 'recruitmentDetails': 'Participants were recruited from medical clinics at six medical centers: Duke University, University of Miami, New York University Grossman School of Medicine/Bellevue Hospital Center, University of North Carolina at Chapel Hill, Stanford University, and Vanderbilt University Medical Center. Study enrollment occurred between November 2019 and August 2021.', 'preAssignmentDetails': 'Enrollment numbers and number of participants Started/Completed represent the number of dyads (child and parent).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '898', 'groupId': 'BG000'}, {'value': '902', 'groupId': 'BG001'}, {'value': '1800', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Greenlight Plus', 'description': "Families will receive the Greenlight intervention plus a health information technology (HIT) intervention aimed at supporting family goal-setting and behavior change. This design allows us to determine if HIT and the asynchronous support it provides between well-child visits can promote additional behavior change and obesity prevention.\n\nGreenlight Plus: Families randomized to the Greenlight Plus arm will receive a HIT intervention starting at the newborn clinic visit. During the newborn visit, these families will receive basic instructions on how to access the Greenlight technology platform, which includes the iOTA text-messaging application and a website (usable on desktop or mobile platform). Families will receive text messages and goal-setting over the first 2 years of the child's life.\n\nGreenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials."}, {'id': 'BG001', 'title': 'Greenlight', 'description': 'During each of the recommended well child visits from 0-24 months, pediatric residents, trained in clear health communication skills and shared goal-setting, will use the Greenlight Toolkit of low literacy, age- specific, parent education booklets to promote healthy family behaviors and obesity prevention.\n\nGreenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Child gestational age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'BG000'}, {'value': '451', 'groupId': 'BG001'}, {'value': '899', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39.3', 'groupId': 'BG000', 'lowerLimit': '38.6', 'upperLimit': '40.0'}, {'value': '39.1', 'groupId': 'BG001', 'lowerLimit': '38.4', 'upperLimit': '40.0'}, {'value': '39.1', 'groupId': 'BG002', 'lowerLimit': '38.4', 'upperLimit': '40.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'Child gestational age (weeks)', 'unitOfMeasure': 'weeks', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Data is for the gestational age of children only. Data missing for 1 Greenlight Plus participant.'}, {'title': 'Age, Customized', 'classes': [{'title': 'Parent age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'BG000'}, {'value': '451', 'groupId': 'BG001'}, {'value': '900', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30.2', 'groupId': 'BG000', 'lowerLimit': '25.6', 'upperLimit': '34.2'}, {'value': '30.1', 'groupId': 'BG001', 'lowerLimit': '25.6', 'upperLimit': '34.4'}, {'value': '30.1', 'groupId': 'BG002', 'lowerLimit': '25.6', 'upperLimit': '34.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Data is for the age of parents only.'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Sex of child-Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '898', 'groupId': 'BG000'}, {'value': '902', 'groupId': 'BG001'}, {'value': '1800', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '243', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '476', 'groupId': 'BG002'}]}]}, {'title': 'Sex of child-Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '898', 'groupId': 'BG000'}, {'value': '902', 'groupId': 'BG001'}, {'value': '1800', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '424', 'groupId': 'BG002'}]}]}, {'title': 'Sex of parent-Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '898', 'groupId': 'BG000'}, {'value': '902', 'groupId': 'BG001'}, {'value': '1800', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '433', 'groupId': 'BG000'}, {'value': '441', 'groupId': 'BG001'}, {'value': '874', 'groupId': 'BG002'}]}]}, {'title': 'Sex of parent-Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '898', 'groupId': 'BG000'}, {'value': '902', 'groupId': 'BG001'}, {'value': '1800', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Sex of parent-Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '898', 'groupId': 'BG000'}, {'value': '902', 'groupId': 'BG001'}, {'value': '1800', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Child race/ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'BG000'}, {'value': '451', 'groupId': 'BG001'}, {'value': '898', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Black, non-Hispanic', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '405', 'groupId': 'BG002'}]}, {'title': 'White, non-Hispanic', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}, {'title': 'Other or multiple', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}]}, {'title': 'Parent race/ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'BG000'}, {'value': '451', 'groupId': 'BG001'}, {'value': '900', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Black, non-Hispanic', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '445', 'groupId': 'BG002'}]}, {'title': 'White, non-Hispanic', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}, {'title': 'Other or multiple', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data missing for 2 Greenlight Plus participants.'}, {'title': 'Child birth weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'BG000'}, {'value': '451', 'groupId': 'BG001'}, {'value': '899', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'BG000', 'lowerLimit': '3.1', 'upperLimit': '3.6'}, {'value': '3.3', 'groupId': 'BG001', 'lowerLimit': '3.0', 'upperLimit': '3.6'}, {'value': '3.3', 'groupId': 'BG002', 'lowerLimit': '3.0', 'upperLimit': '3.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Data missing for 1 Greenlight Plus participant.'}, {'title': 'Parent health literacy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'BG000'}, {'value': '435', 'groupId': 'BG001'}, {'value': '871', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Adequate', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '371', 'groupId': 'BG002'}]}, {'title': 'Limited', 'measurements': [{'value': '250', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Parent health literacy was assessed by the Newest Vital Sign 6-item literacy screening tool. A score greater than or equal to 4 was categorized as adequate.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data missing for 13 Greenlight Plus and 16 Greenlight participants.'}, {'title': 'Parent preferred language', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'BG000'}, {'value': '451', 'groupId': 'BG001'}, {'value': '900', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Spanish', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '313', 'groupId': 'BG002'}]}, {'title': 'English', 'measurements': [{'value': '294', 'groupId': 'BG000'}, {'value': '293', 'groupId': 'BG001'}, {'value': '587', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data is for the preferred language of parents only'}, {'title': 'Parent education level', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'BG000'}, {'value': '451', 'groupId': 'BG001'}, {'value': '900', 'groupId': 'BG002'}]}], 'categories': [{'title': 'No school', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Grade school (K-4)', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Middle school (5-8)', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Some high school (9-12)', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}, {'title': 'High school graduate or GED', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}, {'title': 'Some college or technical/vocational school', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}, {'title': 'College degree', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}, {'title': 'Post graduate or professional degree', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data is for the education level of parents only'}, {'title': 'Annual household income', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'BG000'}, {'value': '451', 'groupId': 'BG001'}, {'value': '900', 'groupId': 'BG002'}]}], 'categories': [{'title': '<$20,000', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}, {'title': '$20,000 to $49,000', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}, {'title': '$50,000 to $99,999', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': '$100,000 or more', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}, {'title': 'Do not know/not sure', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}, {'title': 'Prefer not to answer', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data is for the income of the household'}, {'title': 'Household food insecurity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'BG000'}, {'value': '448', 'groupId': 'BG001'}, {'value': '894', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Food insecure', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}, {'title': 'Food secure', 'measurements': [{'value': '379', 'groupId': 'BG000'}, {'value': '374', 'groupId': 'BG001'}, {'value': '753', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Food insecurity was assessed by the 6-item US Department of Agriculture measure. A score greater than or equal to 2 was categorized as food insecure.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data is for the household. Data missing from 3 Greenlight Plus and 3 Greenlight households.'}], 'populationDescription': 'The number of individual participants in the Greenlight Plus group was n=898 (449 children and 449 parents), and the number of individual participants in the Greenlight group was n=902 (451 children and 451 parents).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-04', 'size': 815147, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-26T16:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "All Greenlight Plus personnel that are in a position to change the study protocol or its implementation in study participants should be blinded to information that may allow them to do so, from when the study starts until the study ends, with specific exceptions. This means that all investigators and study staff should be blinded to study data aggregated by study arm that have the potential to impact the study's outcome.\n\nThe study statistician and programmers s/he designates will be unblinded to post-randomization outcome, mediator, moderator and process data for the purposes of generating DSMB reports.\n\nThe study statistician will remain objective when carrying out the activities of conducting the trials - preparing randomization schemes, processing of the data, cleaning and editing the data, preparation of analyses/reports of outcome, mediator, moderator and blinded process data, and transmitting those data to the DSMB."}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 900}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2019-07-19', 'resultsFirstSubmitDate': '2025-07-28', 'studyFirstSubmitQcDate': '2019-07-31', 'lastUpdatePostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-29', 'studyFirstPostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child Weight for Length Trajectory', 'timeFrame': 'Baseline to 24 months', 'description': 'The primary outcome was child weight for length (kg/m) trajectory over 2 years. Weight and length measurements were obtained during pediatric care visits and abstracted from the medical record.'}], 'secondaryOutcomes': [{'measure': 'Child BMI Z-score Trajectory', 'timeFrame': 'Baseline to 24 months'}, {'measure': 'Child Weight-for-length Z-score Trajectory', 'timeFrame': 'Baseline to 24 months'}, {'measure': 'Child Overweight and/or Obesity', 'timeFrame': 'at 24 months', 'description': 'Outcome defined by CDC or WHO standards'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Behavior, Health', 'Child Obesity']}, 'referencesModule': {'references': [{'pmid': '36323344', 'type': 'BACKGROUND', 'citation': 'Heerman WJ, Perrin EM, Yin HS, Schildcrout JS, Delamater AM, Flower KB, Sanders L, Wood C, Kay MC, Adams LE, Rothman RL. The Greenlight Plus Trial: Comparative effectiveness of a health information technology intervention vs. health communication intervention in primary care offices to prevent childhood obesity. Contemp Clin Trials. 2022 Dec;123:106987. doi: 10.1016/j.cct.2022.106987. Epub 2022 Oct 30.'}, {'pmid': '39489149', 'type': 'RESULT', 'citation': 'Heerman WJ, Rothman RL, Sanders LM, Schildcrout JS, Flower KB, Delamater AM, Kay MC, Wood CT, Gross RS, Bian A, Adams LE, Sommer EC, Yin HS, Perrin EM; Greenlight Investigators; de la Barrera B, Bility M, Cruz Jimenez Smith M, Cruzatte EF, Guevara G, Howard JB, Lampkin J, Orr CJ, Pilotos McBride J, Quintana Forster L, Ramirez KS, Rodriguez J, Schilling S, Shepard WE, Soto A, Velazquez JJ, Wallace S. A Digital Health Behavior Intervention to Prevent Childhood Obesity: The Greenlight Plus Randomized Clinical Trial. JAMA. 2024 Dec 24;332(24):2068-2080. doi: 10.1001/jama.2024.22362.'}]}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial enrolling 900 parent-infant dyads (English and Spanish speaking) comparing Greenlight (control), a behavioral intervention focusing on nutrition, physical activity, media use, and sleep as compared to Greenlight Plus (intervention) which includes the above materials plus a health information technology (HIT) intervention aimed at supporting family goal-setting and behavior change during well-child checks throughout the first 2 years of life.', 'detailedDescription': 'The investigators propose a randomized trial to compare the effectiveness of two different approaches to early childhood obesity prevention in children 0-2 years of age. The investigators will randomize 900 parent-infant dyads, recruited from six newborn nurseries/primary care clinics. The participating organizations are part of both CORNET, a national practice-based research network of pediatric residency primary care practices supported by the Academic Pediatric Association (APA), and PCORnet, the national research network supported by PCORI. In the nursery or at the first newborn clinic visit, eligible families will be consented and randomized to one of two arms. In Arm 1 ("Greenlight"), during each of the recommended well child visits from 0-24 months, pediatric residents, trained in clear health communication skills and shared goal-setting, will use the Greenlight Toolkit of low literacy, age-specific, parent education booklets to promote healthy family behaviors and obesity prevention. In Arm 2 ("Greenlight Plus"), families will receive the Greenlight intervention plus a health information technology (HIT) intervention aimed at supporting family goal-setting and behavior change. This design allows us to determine if HIT and the asynchronous support it provides between well-child visits can promote additional behavior change and obesity prevention.\n\nSpecific Aims \\& Hypotheses (H) include:\n\nAim 1: Compare the effectiveness of the 2 arms on weight-for-length and other weight measures through age 2.\n\nH1: Arm 2 will be significantly better than Arm 1 in supporting healthy child weight-for-length trajectory over 2 years;\n\nAim 2: Compare the effectiveness of the two approaches on parent-reported outcomes, including child feeding and physical activity behaviors, parent feeding beliefs and behaviors, media use, and quality of doctor-patient communication.\n\nH2: Arm 2 will be significantly better at improving parent-reported health behaviors.\n\nAim 3: Examine differences in main outcomes by social determinants, including race/ethnicity, language, health literacy.\n\nH3: A literacy- and culturally-sensitive approach to obesity prevention will result in equal subgroup improvements.\n\nAim 4: To compare weight-for-length trajectory over 2 years in both intervention arms with a non-enrolled comparison group, using data from the PCORnet Common Data Model at participating sites.\n\nH4: PCORnet analysis will reveal the benefit of both Greenlight approaches (Arms 1 and 2) compared to before Greenlight intervention implementation and the added benefit of Arm 2 (Greenlight Plus) over other approaches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '21 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor this study, eligible caregiver/infant dyads will be those with:\n\n1. an English- or Spanish-speaking parent/legal guardian,\n2. infant born in the newborn nursery with plans to have care in the local clinic OR presenting in that clinic for the first newborn visit (1-21 days of life),\n3. attendance at first newborn clinic visit\n4. no plans to leave the clinic within 2 years\n5. Completion of baseline data collection (survey data, child weight and length measures prior to randomization).\n6. Own a smartphone with access to data services\n\nExclusion Criteria:\n\nInfant exclusion criteria:\n\n1. born prior to 34 weeks gestation or birth weight \\<1500 grams; weight \\<3rd %tile at enrollment (World Health Organization growth curves); or\n2. any chronic medical problem that may affect weight gain (e.g., metabolic disease, uncorrected congenital heart disease, renal disease, high-calorie formula; cleft palate; Down syndrome).\n\nCaregiver exclusion criteria include:\n\n1. \\<18 years old;\n2. serious mental or neurologic illness that impairs ability to consent/participate;\n3. poor visual acuity (corrected vision worse than 20/50 with Rosenbaum Screener).\n4. biological mother is HIV-positive'}, 'identificationModule': {'nctId': 'NCT04042467', 'briefTitle': 'Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Greenlight Plus Study: A Randomized Study of Approaches to Early Childhood Obesity Prevention', 'orgStudyIdInfo': {'id': '190311'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Greenlight Plus', 'description': 'Families will receive the Greenlight intervention plus a health information technology (HIT) intervention aimed at supporting family goal-setting and behavior change.\n\nThis design allows us to determine if HIT and the asynchronous support it provides between well-child visits can promote additional behavior change and obesity prevention.', 'interventionNames': ['Behavioral: Greenlight Plus', 'Behavioral: Greenlight']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Greenlight', 'description': 'During each of the recommended well child visits from 0-24 months, pediatric residents, trained in clear health communication skills and shared goal-setting, will use the Greenlight Toolkit of low literacy, age- specific, parent education booklets to promote healthy family behaviors and obesity prevention.', 'interventionNames': ['Behavioral: Greenlight']}], 'interventions': [{'name': 'Greenlight Plus', 'type': 'BEHAVIORAL', 'description': "Families randomized to the Greenlight Plus arm will receive a HIT intervention starting at the newborn clinic visit. During the newborn visit, these families will receive basic instructions on how to access the Greenlight technology platform, which includes the iOTA text-messaging application and a website (usable on desktop or mobile platform). Families will receive text messages and goal-setting over the first 2 years of the child's life.", 'armGroupLabels': ['Greenlight Plus']}, {'name': 'Greenlight', 'type': 'BEHAVIORAL', 'description': 'All residents and families seen in the participating clinics will receive the basic Greenlight materials.', 'armGroupLabels': ['Greenlight', 'Greenlight Plus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27708', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '37203-2494', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Russell Rothman, MD, MPP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}, {'name': 'William Heerman, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}, {'name': 'Charles Wood, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Kori Flower, MD, MS, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}, {'name': 'Lee Sanders, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'H. Shonna Yin, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU School of Medicine, NYU Langone Health'}, {'name': 'Alan Delamater, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}, {'name': 'Eliana Perrin, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}, {'name': 'Duke University', 'class': 'OTHER'}, {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, {'name': 'Stanford University', 'class': 'OTHER'}, {'name': 'NYU Langone Health', 'class': 'OTHER'}, {'name': 'University of Miami', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Internal Medicine and Pediatrics', 'investigatorFullName': 'Bill Heerman', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}