Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-02-28 @ 12:03 AM
Study NCT ID:
NCT03151694
Status:
UNKNOWN
Last Update Posted:
2017-05-12
First Post:
2017-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain-to-Society Diagnostic for Prevention of Childhood Obesity and Chronic Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D001835', 'term': 'Body Weight'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA saliva samples were collected for healthy participants between the ages of 6 and 12 years old before proceeding with genotyping of the 7-repeat risk allele on dopamine-4 receptor (DRD4) gene.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1224}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-11', 'studyFirstSubmitDate': '2017-05-02', 'studyFirstSubmitQcDate': '2017-05-11', 'lastUpdatePostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Individual-level BtS Diagnostic 1', 'timeFrame': '2 years', 'description': 'Genotyping and detection of the Taq1A allele in the dopamine-2 receptor (DRD2) gene.'}, {'measure': 'Individual-level BtS Diagnostic 2', 'timeFrame': '2 years', 'description': 'Genotyping and detection of the exon 3 7-repeat allele of the dopamine-4 receptor (DRD4) gene.'}], 'secondaryOutcomes': [{'measure': 'Behavioral Assessment', 'timeFrame': '2 years', 'description': 'Assess behavior of each participant in relation to food choice'}, {'measure': 'Body Weight Assessment', 'timeFrame': '2 years', 'description': 'Assess body weight of each participant'}, {'measure': 'Nutritional Risk Assessment', 'timeFrame': '2 years', 'description': 'Assess nutrition intake for each participant.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['childhood obesity', 'body weight', 'nutritional risk'], 'conditions': ['Obesity']}, 'referencesModule': {'availIpds': [{'url': 'http://onlinelibrary.wiley.com/doi/10.1111/jcpp.12646/full', 'type': 'Peer-Reviewed Article'}, {'url': 'http://jamanetwork.com/journals/jamapediatrics/fullarticle/2529982', 'type': 'Peer-Reviewed Article'}, {'url': 'http://jamanetwork.com/journals/jamapediatrics/fullarticle/2529983', 'type': 'Peer-Reviewed Article'}]}, 'descriptionModule': {'briefSummary': 'This multi-national program applies a breakthrough approach to childhood obesity called, Brain-to-Society (BtS) Diagnostic Approach. In Montreal, Canada and Palwal, India, the investigators will recruit two cohorts of 612 children (6 to 12 years; 306 boy/306 girls) where Whole-of-Society (WoS) transformations are taking place (industrialized societal context with peaking childhood obesity and where a broad governmental plan to promote healthy lifestyle has been adopted -Canada; developing societal context with increasing childhood obesity if replication of past pathways that have lead to double burden; India) are taking place along with World Health Assembly (WHA) resolution A63-12 for marketing of food to children. Individual-level BtS Diagnostic will examine the degree to which individual differences in genetics and biology and differences in the environmental exposures modulate the behavioral, body weight/fatness and nutritional risk over time in the context of WoS transformations. Societal-level BtS Diagnostic shall examine the influence of decisions in policy, investment, business and innovation made by different stakeholders (government, private sector, civil society in health and non-health society systems including agriculture, business and media practices) on the community.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In two field settings, Canada (Montreal) and India (Palwal), two cohorts of 612 children (6 to 12 years; 306 boy/306 girls) were recruited. Only one child per family was recruited.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sample population that are exposed to multi-level Whole-of-Society transformation (i.e., Quebec Governmental Action Plan (PAG) and World Health Assembly (WHA) resolution for Quebec sample; Intense Urbanization and Industrialization (IUI) and WHA resolution in India).\n\nExclusion Criteria:\n\n* first cousin relations were excluded from the sample population.'}, 'identificationModule': {'nctId': 'NCT03151694', 'briefTitle': 'Brain-to-Society Diagnostic for Prevention of Childhood Obesity and Chronic Disease', 'organization': {'class': 'OTHER', 'fullName': 'McGill University'}, 'officialTitle': 'Foundational Work for a Brain-to-Society Diagnostic for Prevention of Childhood Obesity and Its Chronic Diseases Consequences', 'orgStudyIdInfo': {'id': '227856'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DRD4 and DRD2 Polymorphism Detection', 'description': 'The genetic component of endophenotype for responsiveness to environment (ERE) will be characterized with reference to Taq1A allele in dopamine-2 receptor (DRD2) gene and the exon 3 7-repeat allele of the dopamine-4 receptor (DRD4) gene. This will assist in understanding the role of DRD2 and DRD4 in shaping the neurocognitive functions and link to the eating behaviors of the children and other primary outcome variables.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3A 1X9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill Centre for the Convergence of Health and Economics (MCCHE)', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '110020', 'city': 'New Delhi', 'country': 'India', 'facility': 'The INCLEN Trust International', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'overallOfficials': [{'name': 'Laurette Dubé, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The INCLEN Trust International', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}