- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03128112
Healthy Weight Poster, Multi-site Study
June 27, 2019 updated by: Wake Forest University Health Sciences
Using a Poster Depicting Healthy Weight to Improve Perception of Weight, a Multi-site Study
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.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
965
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Huntsville, Alabama, United States, 35801
- UAB Health Center Huntsville
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-
Kentucky
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Crestview Hills, Kentucky, United States, 41017
- Pediatric Associates of Northern Kentucky
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North Carolina
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Durham, North Carolina, United States, 27617
- Duke Children's Primary Care Brier Creek
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Durham, North Carolina, United States, 27704
- Duke Health Center at Roxboro Street
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Winston-Salem, North Carolina, United States, 27101
- Downtown Health Plaza
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Winston-Salem, North Carolina, United States, 27103
- Ford Simpson Lively and Rice Pediatrics
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Washington
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Bellevue, Washington, United States, 98007
- Public Health Center - Eastgate
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 8 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children aged 3-8 years old presenting to pediatric clinic for a well-child visit.
- Parents of include children who speak English or Spanish and are able to complete a written survey.
Exclusion Criteria:
- Parents that are <18 years old
- Children with no documented weight or height for their visit
- Any medical condition that would affect weight gain or growth such as failure to thrive, congenital heart defect, etc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Exam room without poster
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.
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|
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Active Comparator: Exam room with poster
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Poster assessment prompts by questionnaire
Time Frame: End of study - 1 year
|
Assess whether the poster prompts parents to ask their child's doctor whether their child is a healthy weight.
|
End of study - 1 year
|
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Parents' perceptions by questionnaire
Time Frame: End of study - 1 year
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Assess whether the poster improves accuracy of parents' perceptions of their children's weight status.
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End of study - 1 year
|
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Changes in parental perception by questionnaire
Time Frame: End of study - 1 year
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Among parents who view the poster, the investigators will assess whether parental perception changes differentially based on parental race/ethnicity, education, or socioeconomic background.
|
End of study - 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Callie L Brown, MD MPH, Wake Forest University Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2017
Primary Completion (Actual)
April 30, 2018
Study Completion (Actual)
April 30, 2018
Study Registration Dates
First Submitted
April 12, 2017
First Submitted That Met QC Criteria
April 20, 2017
First Posted (Actual)
April 25, 2017
Study Record Updates
Last Update Posted (Actual)
June 28, 2019
Last Update Submitted That Met QC Criteria
June 27, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00042929
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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