Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-05 @ 11:31 PM
Study NCT ID:
NCT03028233
Status:
COMPLETED
Last Update Posted:
2019-05-03
First Post:
2017-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Kids & Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 244}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-01', 'studyFirstSubmitDate': '2017-01-10', 'studyFirstSubmitQcDate': '2017-01-19', 'lastUpdatePostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'child BMI z-score', 'timeFrame': '2 years', 'description': 'Weight and height is measured using standard methodology, with children wearing light clothing and no shoes. Weight is measured to the nearest 0.5 lb on a digital scale. Height is measured to the nearest tenth of a centimeter using a stadiometer. BMI is calculated: weight (kg)/height squared (meters) for age and gender using United States Centers for Disease Control and Prevention BMI charts growth charts.'}], 'secondaryOutcomes': [{'measure': 'Child Dietary Behaviors: Overall', 'timeFrame': '2 years', 'description': 'This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)'}, {'measure': 'Child Dietary Behaviors for snacks', 'timeFrame': '2 years', 'description': 'This Outcome Measure is assessed through the following measure, modified for verbal administration:Snack items from the Beverage and Snack Questionnaire2 (BSQ2) (https://sharedresources.fredhutch.org/documents/beverage-and-snack-questionnaire-2)'}, {'measure': 'Child Dietary Behaviors for Beverages', 'timeFrame': '2 years', 'description': 'This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)'}, {'measure': 'Parent Dietary Behaviors: Overall', 'timeFrame': '2 years', 'description': 'This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)'}, {'measure': 'Parent Dietary Behaviors for Snacks', 'timeFrame': '2 years', 'description': 'This Outcome Measure is assessed through the following measure, modified for verbal administration: Snack items from the Beverage and Snack Questionnaire2 (BSQ2) (https://sharedresources.fredhutch.org/documents/beverage-and-snack-questionnaire-2)'}, {'measure': 'Parent Dietary Behaviors for Beverages', 'timeFrame': '2 years', 'description': 'This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)'}, {'measure': 'Child Physical Activity and Sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey', 'timeFrame': '2 years', 'description': 'This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)'}, {'measure': 'Child Physical Activity and Sedentariness: C-PAQ and PAQ-C', 'timeFrame': '2 years', 'description': 'This Outcome Measure is assessed through the following measure, modified for verbal administration:Selected items from the Physical Activity C-PAQ (Kemper et al) plus PAQ-C (Kowalski et al) activity questions'}, {'measure': 'Child Physical Activity and Sedentariness: ActiGraph GT1M', 'timeFrame': '2 years', 'description': 'Child physical activity and sedentariness are measured by the child wearing the ActiGraph Model GT1M for 7 days averaged. This measure provides data on intensity and duration of activities.'}, {'measure': 'Parent physical activity and sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey', 'timeFrame': '2 years', 'description': 'This Outcome Measure is assessed through the following measure, modified for verbal administration:Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)'}, {'measure': 'Parent physical activity and sedentariness: C-PAQ and PAQ-C', 'timeFrame': '2 years', 'description': 'This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Physical Activity C-PAQ (Kemper et al) plus PAQ-C (Kowalski et al) activity questions'}, {'measure': 'Parent physical activity and sedentariness: ActiGraph GT1M', 'timeFrame': '2 years', 'description': 'Parent physical activity and sedentariness are measured by the parent wearing the ActiGraph Model GT1M for 7 days averaged. This measure provides data on intensity and duration of activities'}, {'measure': 'Parent BMI', 'timeFrame': '2 years', 'description': 'BMI is calculated with weight and height measurements using standard methodology. Weight is measured to the nearest 0.5 lb on a digital scale. Height is measured to the nearest centimeter using a stadiometer. BMI is calculated: weight (kg)/height squared (meters) for gender using United States Centers for Disease Control and Prevention BMI charts.'}, {'measure': 'Child utilization of built environment resources', 'timeFrame': '2 years', 'description': "Child utilization of built environment resources is assessed by the children wearing a portable GPS unit (\\~size of a matchbox) when wearing an accelerometer. The GPS unit records the geographic coordinates of the child's activities. Measures of frequency and duration of activities by neighborhood space (e.g., parks) can be ascertained."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physical activity', 'healthy eating', 'weight', 'families', 'Community Health Worker', 'childhood obesity', 'built environment'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '31171975', 'type': 'DERIVED', 'citation': 'Borg A, Haughton CF, Sawyer M, Lemon SC, Kane K, Pbert L, Li W, Rosal MC. Design and methods of the Healthy Kids & Families study: a parent-focused community health worker-delivered childhood obesity prevention intervention. BMC Obes. 2019 Jun 3;6:19. doi: 10.1186/s40608-019-0240-x. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.\n\nThis intervention will be compared to a control condition consisting of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.', 'detailedDescription': 'The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.\n\nThis intervention will be compared to a control condition consisting of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.\n\nThe intervention uses multiple delivery modalities to maintain novelty and prevent attrition/burden. These include home visits, telephone contacts, print (literacy sensitive newsletters), social media (Facebook), and community events. Parents and children will complete scheduled assessments at baseline, 6-, 12-, 18- and 24-month follow-up.\n\nThe Specific Aims are:\n\nAim 1: To determine the effectiveness of the intervention compared to the control condition on child physical activity, healthy eating, BMI and utilization of built environment resources.\n\nAim 2: To determine the effectiveness of the intervention compared to the control condition on parent physical activity, healthy eating, BMI.\n\nAim 3: To examine the potential scalability of the intervention guided by the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible individuals for the research study are parents/guardians and their K-6th grade children attending one of 9 schools in the greater Worcester area. Parents and their children are recruited as parent-child dyads.\n\nExclusion Criteria:\n\n* Has an inability or unwillingness to give informed consent or assent\n* Is a prisoner\n\nExclusion (child only)\n\n* The child has been told by a doctor that they cannot walk or eat fruits and vegetables.'}, 'identificationModule': {'nctId': 'NCT03028233', 'briefTitle': 'Healthy Kids & Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'Healthy Kids & Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention', 'orgStudyIdInfo': {'id': 'H00005048'}, 'secondaryIdInfos': [{'id': 'U48DP005031', 'link': 'https://reporter.nih.gov/quickSearch/U48DP005031', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Lifestyles', 'description': 'The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.', 'interventionNames': ['Behavioral: Healthy Lifestyle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Positive Parenting', 'description': 'The control condition consists of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.', 'interventionNames': ['Behavioral: Positive Parenting']}], 'interventions': [{'name': 'Healthy Lifestyle', 'type': 'BEHAVIORAL', 'description': 'A Community Health Worker coaches families regarding healthy eating, physical activity, and obesity prevention, and promotes the use of existing built environment resources.', 'armGroupLabels': ['Healthy Lifestyles']}, {'name': 'Positive Parenting', 'type': 'BEHAVIORAL', 'description': 'A Community Health Worker coaches parents on improving positive parenting skills and promotes the use of relevant community resources.', 'armGroupLabels': ['Positive Parenting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMass Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'Milagros C Rosal, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMass Medical School'}, {'name': 'Wenjun Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMass Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oak Hill Community Development Corporation', 'class': 'UNKNOWN'}, {'name': 'Worcester Public Schools', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Milagros Rosal', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}