Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2026-02-25 @ 7:17 PM
Study NCT ID:
NCT01768533
Status:
COMPLETED
Last Update Posted:
2013-01-15
First Post:
2012-12-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Behavioral Informatics to Prevent Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 305}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-11', 'studyFirstSubmitDate': '2012-12-26', 'studyFirstSubmitQcDate': '2013-01-11', 'lastUpdatePostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Physical activity', 'timeFrame': 'one time point (baseline only)', 'description': 'amount of time spent in moderate or greater physical activity'}, {'measure': 'fruit and vegetables', 'timeFrame': 'one time point (baseline only)', 'description': 'amount of fruit servings and vegetable servings consumed per day.'}, {'measure': 'screen time', 'timeFrame': 'one time point (baseline only)', 'description': 'amount of time spent watching television or recreational videos or computers'}], 'primaryOutcomes': [{'measure': 'sugar-sweetened beverages', 'timeFrame': 'one time point (baseline only)', 'description': 'Behavioral outcome measure of the amount of sugar-sweetened beverages consumed.'}], 'secondaryOutcomes': [{'measure': 'BMI', 'timeFrame': 'one time point (baseline only)', 'description': 'weight status as defined by body mass index (BMI)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pediatric', 'obesity', 'prevention', 'health behaviors', 'guidelines'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '29112721', 'type': 'DERIVED', 'citation': 'Wright JA, Whiteley JA, Watson BL, Sheinfeld Gorin SN, Hayman LL. Tailored communications for obesity prevention in pediatric primary care: a feasibility study. Health Educ Res. 2018 Feb 1;33(1):14-25. doi: 10.1093/her/cyx063.'}, {'pmid': '24750693', 'type': 'DERIVED', 'citation': 'Wright JA, Adams WG, Laforge RG, Berry D, Friedman RH. Assessing parental self-efficacy for obesity prevention related behaviors. Int J Behav Nutr Phys Act. 2014 Apr 22;11:53. doi: 10.1186/1479-5868-11-53.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to do formative research which will lead ultimately to the development of a computer-based system called Tailored Information for Diet and Exercise or TIDE for short. TIDE will target energy balance behaviors to prevent the onset of obesity in children. The system will be used by physicians and parents/primary care givers in pediatric primary care practices with the aim of improving parent-pediatrician interactions related to counseling and anticipatory guidance on energy balance behaviors. The aim of this study is to develop a one-two page, paper-pencil proxy questionnaire that is used to query the parent of the child in the waiting room and assesses topic areas related to energy balance behaviors (EBB). The questionnaire will be referred to as the energy balance behaviors questionnaire (EBB-Q). This will require focus groups, cognitive testing of the questionnaire, and survey administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "General population of parents with children ages 4-10 years who reside in the Greater Boston area. Parents are defined as primary care givers or legal guardians who take primary responsibility for the child's health which includes attending the child's well-care visits.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary care givers or legal guardians of children 4-10 years of age who has attended the last two well-child visits with their child\n\nExclusion Criteria:\n\n* parent cares for a child who is on a special diet prescribed by pediatrician'}, 'identificationModule': {'nctId': 'NCT01768533', 'acronym': 'TIDE', 'briefTitle': 'Pediatric Behavioral Informatics to Prevent Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Boston'}, 'officialTitle': 'Pediatric Behavioral Informatics to Prevent Cancer', 'orgStudyIdInfo': {'id': '5K07CA113643', 'link': 'https://reporter.nih.gov/quickSearch/5K07CA113643', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Survey', 'description': 'A lifestyle survey was administered to primary-care givers or legal guardians who take their children 4-10 y/o to the pediatric well-child visits.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02155', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMass Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Julie A Wright, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMass Boston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Boston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Julie Wright', 'investigatorAffiliation': 'University of Massachusetts, Boston'}}}}