Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-12 @ 7:31 PM
Study NCT ID:
NCT03141151
Status:
COMPLETED
Last Update Posted:
2020-03-20
First Post:
2017-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Competency-based Approaches to Community Health
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'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': 'bill.heerman@vumc.org', 'phone': '615-322-7080', 'title': 'William Heerman, MD MPH', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The study was conducted among Latino families; findings should not be generalized to other populations.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected throughout the study. We specifically asked about adverse events and serious adverse events at each follow-up time point (4 months, 7 months, 1 year), but always completed follow-up and documentation for any event in between data collection time points.', 'eventGroups': [{'id': 'EG000', 'title': 'COACH: Healthy Bodies', 'description': 'This will be a staged intensity behavioral intervention. The intensive phase will last 15 weeks and consist of weekly, 90 minute, skills-building sessions. The content will focus on diet, physical activity, sleep, media use, and parenting. Behavior change techniques will include goal-setting, self-monitoring, and problem solving. Following the intensive phase, participants will enter a maintenance phase, consisting of monthly phone calls from a health coach for 3 months.\n\nCOACH: Healthy Bodies: Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'COACH: Strong Minds', 'description': 'This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months. Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy.\n\nCOACH: Strong Minds: School Readiness Intervention focusing on literacy and parent skills', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 0, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Child Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COACH: Healthy Bodies', 'description': 'This will be a staged intensity behavioral intervention. The intensive phase will last 15 weeks and consist of weekly, 90 minute, skills-building sessions. The content will focus on diet, physical activity, sleep, media use, and parenting. Behavior change techniques will include goal-setting, self-monitoring, and problem solving. Following the intensive phase, participants will enter a maintenance phase, consisting of monthly phone calls from a health coach for 3 months.\n\nCOACH: Healthy Bodies: Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family.'}, {'id': 'OG001', 'title': 'COACH: Strong Minds', 'description': 'This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months. Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy.\n\nCOACH: Strong Minds: School Readiness Intervention focusing on literacy and parent skills'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.1', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '18.1', 'spread': '3.0', 'groupId': 'OG001'}]}]}, {'title': '4 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.1', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '18.2', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': '7 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.0', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '18.4', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.5', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '18.7', 'spread': '3.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 months, 7 months, 1 year', 'description': 'child BMI trajectory across 12 months; BMI differences over time are estimates from the longitudinal mixed-effects regression model', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed differs across each time point as it relates to retention'}, {'type': 'SECONDARY', 'title': 'Child Diet: Soda', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COACH: Healthy Bodies', 'description': 'This will be a staged intensity behavioral intervention. The intensive phase will last 15 weeks and consist of weekly, 90 minute, skills-building sessions. The content will focus on diet, physical activity, sleep, media use, and parenting. Behavior change techniques will include goal-setting, self-monitoring, and problem solving. Following the intensive phase, participants will enter a maintenance phase, consisting of monthly phone calls from a health coach for 3 months.\n\nCOACH: Healthy Bodies: Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family.'}, {'id': 'OG001', 'title': 'COACH: Strong Minds', 'description': 'This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months. Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy.\n\nCOACH: Strong Minds: School Readiness Intervention focusing on literacy and parent skills'}], 'classes': [{'categories': [{'measurements': [{'value': '0.17', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'Parent-reported survey data; Child diet: Soda was measured by a single survey item used in the Feeding Infants and Toddlers Study with higher values representing higher frequency of consumption per day. (citation: Ziegler P, Briefel R, Clusen N, et al. Feeding Infants and Toddlers Study (FITS): Development of the FITS survey in comparison to other dietary survey methods. J Am Diet Assoc 2006;106:S12-S27.)', 'unitOfMeasure': 'Sodas/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Secondary analysis was based on participants with complete data on the Child Diet: Soda measure at baseline and 4 month follow-up timepoints. Note: number of participants analyzed differs slightly from the primary analysis of the primary outcome which was Child BMI.'}, {'type': 'SECONDARY', 'title': 'Child Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COACH: Healthy Bodies', 'description': 'This will be a staged intensity behavioral intervention. The intensive phase will last 15 weeks and consist of weekly, 90 minute, skills-building sessions. The content will focus on diet, physical activity, sleep, media use, and parenting. Behavior change techniques will include goal-setting, self-monitoring, and problem solving. Following the intensive phase, participants will enter a maintenance phase, consisting of monthly phone calls from a health coach for 3 months.\n\nCOACH: Healthy Bodies: Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family.'}, {'id': 'OG001', 'title': 'COACH: Strong Minds', 'description': 'This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months. Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy.\n\nCOACH: Strong Minds: School Readiness Intervention focusing on literacy and parent skills'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'spread': '2.60', 'groupId': 'OG000'}, {'value': '1.62', 'spread': '2.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'Parent-reported survey data', 'unitOfMeasure': 'Child active days per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Secondary analysis was based on participants with complete data on the child active days per week measure at baseline and 4 month follow-up timepoints. Note: number of participants analyzed differs slightly from the primary analysis of the primary outcome which was Child BMI.'}, {'type': 'SECONDARY', 'title': 'Parent BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COACH: Healthy Bodies', 'description': 'This will be a staged intensity behavioral intervention. The intensive phase will last 15 weeks and consist of weekly, 90 minute, skills-building sessions. The content will focus on diet, physical activity, sleep, media use, and parenting. Behavior change techniques will include goal-setting, self-monitoring, and problem solving. Following the intensive phase, participants will enter a maintenance phase, consisting of monthly phone calls from a health coach for 3 months.\n\nCOACH: Healthy Bodies: Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family.'}, {'id': 'OG001', 'title': 'COACH: Strong Minds', 'description': 'This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months. Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy.\n\nCOACH: Strong Minds: School Readiness Intervention focusing on literacy and parent skills'}], 'classes': [{'categories': [{'measurements': [{'value': '30.44', 'spread': '5.86', 'groupId': 'OG000'}, {'value': '31.57', 'spread': '6.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Secondary analysis was based on participants with complete data on the Adult BMI measure at baseline and 4 month follow-up timepoints. Note: number of participants analyzed differs slightly from the primary analysis of the primary outcome which was Child BMI.'}, {'type': 'SECONDARY', 'title': 'Parent Diet Practices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COACH: Healthy Bodies', 'description': 'This will be a staged intensity behavioral intervention. The intensive phase will last 15 weeks and consist of weekly, 90 minute, skills-building sessions. The content will focus on diet, physical activity, sleep, media use, and parenting. Behavior change techniques will include goal-setting, self-monitoring, and problem solving. Following the intensive phase, participants will enter a maintenance phase, consisting of monthly phone calls from a health coach for 3 months.\n\nCOACH: Healthy Bodies: Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family.'}, {'id': 'OG001', 'title': 'COACH: Strong Minds', 'description': 'This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months. Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy.\n\nCOACH: Strong Minds: School Readiness Intervention focusing on literacy and parent skills'}], 'classes': [{'categories': [{'measurements': [{'value': '5.04', 'spread': '4.09', 'groupId': 'OG000'}, {'value': '5.22', 'spread': '4.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'Self-reported survey data; Parent diet practices were measured by using a summed score of a 4-item questionnaire of eating behaviors, including overeating, unplanned eating, making poor food choices, and emotional eating. Higher scores represent more unhealthy parent dieting practices. Items ranged on a scale from 0-5 and were summed to create the scale which ranged from 0-20.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Secondary analysis was based on participants with complete data on the Parent Diet Practices measure at baseline and 4 month follow-up timepoints. Note: number of participants analyzed differs slightly from the primary analysis of the primary outcome which was Child BMI.'}, {'type': 'SECONDARY', 'title': 'Parenting Practices: Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COACH: Healthy Bodies', 'description': 'This will be a staged intensity behavioral intervention. The intensive phase will last 15 weeks and consist of weekly, 90 minute, skills-building sessions. The content will focus on diet, physical activity, sleep, media use, and parenting. Behavior change techniques will include goal-setting, self-monitoring, and problem solving. Following the intensive phase, participants will enter a maintenance phase, consisting of monthly phone calls from a health coach for 3 months.\n\nCOACH: Healthy Bodies: Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family.'}, {'id': 'OG001', 'title': 'COACH: Strong Minds', 'description': 'This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months. Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy.\n\nCOACH: Strong Minds: School Readiness Intervention focusing on literacy and parent skills'}], 'classes': [{'categories': [{'measurements': [{'value': '53.79', 'spread': '12.66', 'groupId': 'OG000'}, {'value': '49.52', 'spread': '13.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'Self-reported survey data; Parenting practices around child physical activity were measured by the Preschooler Physical Activity Parenting Practices (PPAPP) scale which has an engagement subscale. Parenting practices: Engagement was a 15 item subscale of the PPAPP survey with higher scores representing higher parent engagement practices. Items ranged on a scale from 1-5 and were summed to create the subscale which ranged from 15-75.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Secondary analysis was based on participants with complete data on the Parent Practices: Engagement measure at baseline and 4 month follow-up timepoints. Note: number of participants analyzed differs slightly from the primary analysis of the primary outcome which was Child BMI.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'COACH: Healthy Bodies', 'description': 'This will be a staged intensity behavioral intervention. The intensive phase will last 15 weeks and consist of weekly, 90 minute, skills-building sessions. The content will focus on diet, physical activity, sleep, media use, and parenting. Behavior change techniques will include goal-setting, self-monitoring, and problem solving. Following the intensive phase, participants will enter a maintenance phase, consisting of monthly phone calls from a health coach for 3 months.\n\nCOACH: Healthy Bodies: Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family.'}, {'id': 'FG001', 'title': 'COACH: Strong Minds', 'description': 'This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months. Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy.\n\nCOACH: Strong Minds: School Readiness Intervention focusing on literacy and parent skills'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'COACH: Healthy Bodies', 'description': 'This will be a staged intensity behavioral intervention. The intensive phase will last 15 weeks and consist of weekly, 90 minute, skills-building sessions. The content will focus on diet, physical activity, sleep, media use, and parenting. Behavior change techniques will include goal-setting, self-monitoring, and problem solving. Following the intensive phase, participants will enter a maintenance phase, consisting of monthly phone calls from a health coach for 3 months.\n\nCOACH: Healthy Bodies: Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family.'}, {'id': 'BG001', 'title': 'COACH: Strong Minds', 'description': 'This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months. Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy.\n\nCOACH: Strong Minds: School Readiness Intervention focusing on literacy and parent skills'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '4.2', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '4.2', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-02', 'size': 2912533, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-29T14:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The investigators and data collectors will be blinded to randomization status. Because this is a behavioral intervention, the participants and interventionists will be unblinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-05', 'studyFirstSubmitDate': '2017-05-01', 'resultsFirstSubmitDate': '2019-08-30', 'studyFirstSubmitQcDate': '2017-05-03', 'lastUpdatePostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-05', 'studyFirstPostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Child Body Mass Index', 'timeFrame': 'Baseline, 4 months, 7 months, 1 year', 'description': 'child BMI trajectory across 12 months; BMI differences over time are estimates from the longitudinal mixed-effects regression model'}], 'secondaryOutcomes': [{'measure': 'Child Diet: Soda', 'timeFrame': '4 months', 'description': 'Parent-reported survey data; Child diet: Soda was measured by a single survey item used in the Feeding Infants and Toddlers Study with higher values representing higher frequency of consumption per day. (citation: Ziegler P, Briefel R, Clusen N, et al. Feeding Infants and Toddlers Study (FITS): Development of the FITS survey in comparison to other dietary survey methods. J Am Diet Assoc 2006;106:S12-S27.)'}, {'measure': 'Child Physical Activity', 'timeFrame': '4 months', 'description': 'Parent-reported survey data'}, {'measure': 'Parent BMI', 'timeFrame': '4 months'}, {'measure': 'Parent Diet Practices', 'timeFrame': '4 months', 'description': 'Self-reported survey data; Parent diet practices were measured by using a summed score of a 4-item questionnaire of eating behaviors, including overeating, unplanned eating, making poor food choices, and emotional eating. Higher scores represent more unhealthy parent dieting practices. Items ranged on a scale from 0-5 and were summed to create the scale which ranged from 0-20.'}, {'measure': 'Parenting Practices: Engagement', 'timeFrame': '4 months', 'description': 'Self-reported survey data; Parenting practices around child physical activity were measured by the Preschooler Physical Activity Parenting Practices (PPAPP) scale which has an engagement subscale. Parenting practices: Engagement was a 15 item subscale of the PPAPP survey with higher scores representing higher parent engagement practices. Items ranged on a scale from 1-5 and were summed to create the subscale which ranged from 15-75.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Childhood']}, 'referencesModule': {'references': [{'pmid': '31381365', 'type': 'RESULT', 'citation': 'Heerman WJ, Teeters L, Sommer EC, Burgess LE, Escarfuller J, Van Wyk C, Barkin SL, Duhon AA, Cole J, Samuels LR, Singer-Gabella M. Competency-Based Approaches to Community Health: A Randomized Controlled Trial to Reduce Childhood Obesity among Latino Preschool-Aged Children. Child Obes. 2019 Dec;15(8):519-531. doi: 10.1089/chi.2019.0064. Epub 2019 Aug 5.'}, {'pmid': '36316788', 'type': 'DERIVED', 'citation': 'Adams LE, Sommer EC, Truesdale KP, Barkin SL, Heerman WJ. Validation of a new scoring approach of a child dietary questionnaire for use in early childhood among low-income, Latino populations. BMC Nutr. 2022 Oct 31;8(1):125. doi: 10.1186/s40795-022-00618-4.'}]}, 'descriptionModule': {'briefSummary': 'This study is a family-centered, community-based intervention to prevent and treat childhood obesity among 3-5 year old children from undeserved communities. Half of participants will receive a healthy lifestyle intervention and half of participants will receive a school-readiness intervention.', 'detailedDescription': "The complex multi-level determinants of childhood obesity necessitate a personalized approach. One of the main challenges to effective behavior change interventions is the complexity of the systems in which these behaviors are situated. Namely, health behaviors are the result of the confluence of macro-level influences (e.g., the built environment, family, etc.) and micro-level influences (e.g., stress). Furthermore, it is imperative that attempts to support healthy childhood growth consider the foundational contribution of a person's culture to their health behaviors, especially as children from traditionally underserved minorities are often hardest hit by obesity.\n\nThis program will test a 15 week behavioral intervention followed by 3 months of coaching calls that uses principles from the learning sciences and health behavior change to help shape healthy behaviors in the context of family. The follow-up of the study will last 1 year. The content of the intervention will focus on health behavior change, including teaching goal-setting and self monitoring skills, as well as parenting strategies.\n\nThe primary outcome of interest will be early childhood BMI trajectory over 1 year. Additional measures will include survey data to measure parent and child health behaviors (e.g., diet, physical activity, sleep, media use) that are associated with obesity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Three-to-five year old child\n2. Spanish or English-speaking\n3. Child's BMI ≥ 50%\n4. Parental commitment to participate in a year long study\n5. Consistent phone access\n6. Parent age ≥ 18 years\n7. Child completion of baseline data collection on height, weight, and waist circumference and all willing survey items completed by the parent\n8. Parents and children must be healthy (parents with controlled medical conditions will also be eligible).\n9. Dyad must be considered underserved which will be indicated by the parents self-reporting if they or someone in their household participate in one of these programs or services: TennCare, CoverKids, WIC, Food Stamps (SNAP), Free and Reduced Price School Lunch and Breakfast, Families First (TANF), and/or subsidized housing"}, 'identificationModule': {'nctId': 'NCT03141151', 'acronym': 'COACH', 'briefTitle': 'Competency-based Approaches to Community Health', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Competency-based Approaches to Community Health', 'orgStudyIdInfo': {'id': '170420'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COACH: Healthy Bodies', 'description': 'This will be a staged intensity behavioral intervention. The intensive phase will last 15 weeks and consist of weekly, 90 minute, skills-building sessions. The content will focus on diet, physical activity, sleep, media use, and parenting. Behavior change techniques will include goal-setting, self-monitoring, and problem solving. Following the intensive phase, participants will enter a maintenance phase, consisting of monthly phone calls from a health coach for 3 months.', 'interventionNames': ['Behavioral: COACH: Healthy Bodies']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'COACH: Strong minds', 'description': 'This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months. Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy.', 'interventionNames': ['Behavioral: COACH: Strong Minds']}], 'interventions': [{'name': 'COACH: Healthy Bodies', 'type': 'BEHAVIORAL', 'description': 'Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family.', 'armGroupLabels': ['COACH: Healthy Bodies']}, {'name': 'COACH: Strong Minds', 'type': 'BEHAVIORAL', 'description': 'School Readiness Intervention focusing on literacy and parent skills', 'armGroupLabels': ['COACH: Strong minds']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'William Heerman, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Bill Heerman', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}