- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03128112
Healthy Weight Poster, Multi-site Study
27 de junio de 2019 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
965
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Alabama
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Huntsville, Alabama, Estados Unidos, 35801
- UAB Health Center Huntsville
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Kentucky
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Crestview Hills, Kentucky, Estados Unidos, 41017
- Pediatric Associates of Northern Kentucky
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North Carolina
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Durham, North Carolina, Estados Unidos, 27617
- Duke Children's Primary Care Brier Creek
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Durham, North Carolina, Estados Unidos, 27704
- Duke Health Center at Roxboro Street
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Winston-Salem, North Carolina, Estados Unidos, 27101
- Downtown Health Plaza
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Winston-Salem, North Carolina, Estados Unidos, 27103
- Ford Simpson Lively and Rice Pediatrics
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Washington
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Bellevue, Washington, Estados Unidos, 98007
- Public Health Center - Eastgate
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
3 años a 8 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: 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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Comparador activo: 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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Poster assessment prompts by questionnaire
Periodo de tiempo: End of study - 1 year
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Assess whether the poster prompts parents to ask their child's doctor whether their child is a healthy weight.
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End of study - 1 year
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Parents' perceptions by questionnaire
Periodo de tiempo: 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
Periodo de tiempo: 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.
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End of study - 1 year
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Callie L Brown, MD MPH, Wake Forest University Health Sciences
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
20 de junio de 2017
Finalización primaria (Actual)
30 de abril de 2018
Finalización del estudio (Actual)
30 de abril de 2018
Fechas de registro del estudio
Enviado por primera vez
12 de abril de 2017
Primero enviado que cumplió con los criterios de control de calidad
20 de abril de 2017
Publicado por primera vez (Actual)
25 de abril de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de junio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
27 de junio de 2019
Última verificación
1 de enero de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00042929
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .