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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03128112
Other study ID # IRB00042929
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 20, 2017
Est. completion date April 30, 2018

Study information

Verified date January 2019
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 965
Est. completion date April 30, 2018
Est. primary completion date April 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 8 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Exam room with poster
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.

Locations

Country Name City State
United States Public Health Center - Eastgate Bellevue Washington
United States Pediatric Associates of Northern Kentucky Crestview Hills Kentucky
United States Duke Children's Primary Care Brier Creek Durham North Carolina
United States Duke Health Center at Roxboro Street Durham North Carolina
United States UAB Health Center Huntsville Huntsville Alabama
United States Downtown Health Plaza Winston-Salem North Carolina
United States Ford Simpson Lively and Rice Pediatrics Winston-Salem North Carolina

Sponsors (5)

Lead Sponsor Collaborator
Wake Forest University Health Sciences Duke University, Eastgate Public Health Center, Pediatric Associates of Northern Kentucky, UAB Huntsville Pediatrics

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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. Review. — View 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. — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Poster assessment prompts by questionnaire Assess whether the poster prompts parents to ask their child's doctor whether their child is a healthy weight. End of study - 1 year
Primary Parents' perceptions by questionnaire Assess whether the poster improves accuracy of parents' perceptions of their children's weight status. End of study - 1 year
Primary Changes in parental perception by questionnaire 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
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