Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-03-01 @ 8:57 PM
Study NCT ID:
NCT03128112
Status:
COMPLETED
Last Update Posted:
2019-06-28
First Post:
2017-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Weight Poster, Multi-site Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 965}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-27', 'studyFirstSubmitDate': '2017-04-12', 'studyFirstSubmitQcDate': '2017-04-20', 'lastUpdatePostDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Poster assessment prompts by questionnaire', 'timeFrame': 'End of study - 1 year', 'description': "Assess whether the poster prompts parents to ask their child's doctor whether their child is a healthy weight."}, {'measure': "Parents' perceptions by questionnaire", 'timeFrame': 'End of study - 1 year', 'description': "Assess whether the poster improves accuracy of parents' perceptions of their children's weight status."}, {'measure': 'Changes in parental perception by questionnaire', 'timeFrame': 'End of study - 1 year', 'description': 'Among parents who view the poster, the investigators will assess whether parental perception changes differentially based on parental race/ethnicity, education, or socioeconomic background.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parental perception, obesity, overweight'], 'conditions': ['Childhood Obesity']}, 'referencesModule': {'references': [{'pmid': '19302692', 'type': 'BACKGROUND', 'citation': 'Doolen J, Alpert PT, Miller SK. Parental disconnect between perceived and actual weight status of children: a metasynthesis of the current research. J Am Acad Nurse Pract. 2009 Mar;21(3):160-6. doi: 10.1111/j.1745-7599.2008.00382.x.'}, {'pmid': '24488736', 'type': 'BACKGROUND', 'citation': 'Lundahl A, Kidwell KM, Nelson TD. Parental underestimates of child weight: a meta-analysis. Pediatrics. 2014 Mar;133(3):e689-703. doi: 10.1542/peds.2013-2690. Epub 2014 Feb 2.'}, {'pmid': '23020552', 'type': 'BACKGROUND', 'citation': 'Rietmeijer-Mentink M, Paulis WD, van Middelkoop M, Bindels PJ, van der Wouden JC. Difference between parental perception and actual weight status of children: a systematic review. Matern Child Nutr. 2013 Jan;9(1):3-22. doi: 10.1111/j.1740-8709.2012.00462.x. Epub 2012 Oct 1.'}, {'pmid': '21594667', 'type': 'BACKGROUND', 'citation': 'Moore LC, Harris CV, Bradlyn AS. Exploring the relationship between parental concern and the management of childhood obesity. Matern Child Health J. 2012 May;16(4):902-8. doi: 10.1007/s10995-011-0813-x.'}, {'pmid': '20679328', 'type': 'BACKGROUND', 'citation': 'Soto C, White JH. School Health Initiatives and Childhood Obesity: BMI screening and reporting. Policy Polit Nurs Pract. 2010 May;11(2):108-14. doi: 10.1177/1527154410374218. Epub 2010 Aug 2.'}, {'pmid': '12032758', 'type': 'BACKGROUND', 'citation': 'Wake M, Salmon L, Waters E, Wright M, Hesketh K. Parent-reported health status of overweight and obese Australian primary school children: a cross-sectional population survey. Int J Obes Relat Metab Disord. 2002 May;26(5):717-24. doi: 10.1038/sj.ijo.0801974.'}, {'pmid': '20554259', 'type': 'BACKGROUND', 'citation': "Perrin EM, Jacobson Vann JC, Benjamin JT, Skinner AC, Wegner S, Ammerman AS. Use of a pediatrician toolkit to address parental perception of children's weight status, nutrition, and activity behaviors. Acad Pediatr. 2010 Jul-Aug;10(4):274-81. doi: 10.1016/j.acap.2010.03.006. Epub 2010 May 31."}, {'pmid': '24886960', 'type': 'BACKGROUND', 'citation': 'Cates JR, Diehl SJ, Crandell JL, Coyne-Beasley T. Intervention effects from a social marketing campaign to promote HPV vaccination in preteen boys. Vaccine. 2014 Jul 16;32(33):4171-8. doi: 10.1016/j.vaccine.2014.05.044. Epub 2014 Jun 2.'}, {'pmid': '23970960', 'type': 'BACKGROUND', 'citation': 'Gee S, Chin D, Ackerson L, Woo D, Howell A. Prevalence of childhood and adolescent overweight and obesity from 2003 to 2010 in an integrated health care delivery system. J Obes. 2013;2013:417907. doi: 10.1155/2013/417907. Epub 2013 Jul 18.'}, {'pmid': '23496294', 'type': 'BACKGROUND', 'citation': 'Herrera J, Lockner D, Kibbe D, Marley SC, Trowbridge F, Bailey A. Innovative tools help counselors discuss childhood obesity with parents. Child Obes. 2013 Apr;9(2):144-9. doi: 10.1089/chi.2012.0095. Epub 2013 Mar 15.'}, {'pmid': '18574384', 'type': 'BACKGROUND', 'citation': 'Parry LL, Netuveli G, Parry J, Saxena S. A systematic review of parental perception of overweight status in children. J Ambul Care Manage. 2008 Jul-Sep;31(3):253-68. doi: 10.1097/01.JAC.0000324671.29272.04.'}, {'pmid': '19268233', 'type': 'BACKGROUND', 'citation': "Towns N, D'Auria J. Parental perceptions of their child's overweight: an integrative review of the literature. J Pediatr Nurs. 2009 Apr;24(2):115-30. doi: 10.1016/j.pedn.2008.02.032. Epub 2008 Sep 5."}]}, 'descriptionModule': {'briefSummary': "This is a multi-site, cross-sectional study of 3-8 year old children and their parents presenting for a well-child check. The investigators are assessing whether a novel, educational, exam room poster can effectively prompt parents to ask their pediatricians about their children's weight status and improve parents' perceptions of their children's weight status.", 'detailedDescription': "The purpose of this study is to evaluate whether a novel, educational, exam room poster can effectively prompt parents to ask their pediatricians about their children's weight status. Exam rooms within clinics will be randomized to either have the poster or not and parents will complete questionnaires assessing weight perception, whether they discussed their child's weight with their physician, and basic demographics. Participants who are in exam rooms with a poster will also answer questions specifically about the poster."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 3-8 years old presenting to pediatric clinic for a well-child visit.\n* Parents of include children who speak English or Spanish and are able to complete a written survey.\n\nExclusion Criteria:\n\n* Parents that are \\<18 years old\n* Children with no documented weight or height for their visit\n* Any medical condition that would affect weight gain or growth such as failure to thrive, congenital heart defect, etc.'}, 'identificationModule': {'nctId': 'NCT03128112', 'briefTitle': 'Healthy Weight Poster, Multi-site Study', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Using a Poster Depicting Healthy Weight to Improve Perception of Weight, a Multi-site Study', 'orgStudyIdInfo': {'id': 'IRB00042929'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Exam room without poster', 'description': "All parents will be asked to fill out a questionnaire detailing basic demographic information as well as their perception of their child's weight. Parents who are in exam rooms without posters will be ask to fill out a second short questionnaire after seeing their physician that will ask parents whether they discussed their child's weight status with their physician and whether they believe their own child is: very overweight, overweight, healthy weight, underweight, or very underweight."}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exam room with poster', 'description': "All parents will be asked to fill out a questionnaire detailing basic demographic information as well as their perception of their child's weight. Parents who are in exam rooms with posters will be directed to read the poster on the exam room wall. After viewing the poster and after seeing their physician, parents will be ask to fill out a second short questionnaire that will ask parents whether they discussed their child's weight status with their physician, whether this conversation was prompted by the poster, and whether they believe their own child is very overweight, overweight, healthy weight, underweight, or very underweight.", 'interventionNames': ['Other: Exam room with poster']}], 'interventions': [{'name': 'Exam room with poster', 'type': 'OTHER', 'description': "This intervention will assess whether a novel educational exam room poster can effectively prompt patients to ask pediatricians about their children's weight status and improve patents' perceptions of their children's weight status.", 'armGroupLabels': ['Exam room with poster']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Health Center Huntsville', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '41017', 'city': 'Crestview Hills', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Pediatric Associates of Northern Kentucky', 'geoPoint': {'lat': 39.02728, 'lon': -84.58494}}, {'zip': '27617', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': "Duke Children's Primary Care Brier Creek", 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27704', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Health Center at Roxboro Street', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27101', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Downtown Health Plaza', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Ford Simpson Lively and Rice Pediatrics', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Public Health Center - Eastgate', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}], 'overallOfficials': [{'name': 'Callie L Brown, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Duke University', 'class': 'OTHER'}, {'name': 'Eastgate Public Health Center', 'class': 'UNKNOWN'}, {'name': 'UAB Huntsville Pediatrics', 'class': 'UNKNOWN'}, {'name': 'Pediatric Associates of Northern Kentucky', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}