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Chronic Conditions in Childhood Obesity Subject: An Mixed Methods Research Approach

27 de mayo de 2014 actualizado por: National Taiwan University Hospital
Methods: This study will be a three-year mixed methods study, including the identification of obesity issues among children with chronic conditions in the first phase study (2013/10/01-2014/07/31), development of an intervention protocol in the second phase study (2014/08/01-2015/07/31), and conduction/evaluation of an intervention of lifestyle intervention in the third phase study (2015/08/01-2016/07/31). Firstly, anthropometry, healthy lifestyles questionnaire survey on children aged 7-12 and school environment audit will be conducted. By using the literature review, meta-analysis and focus-research approaches to develop a healthy lifestyle intervention protocol in the second year program. The protocol will be tested on a sample of school-age children with asthma, to develop a school-based and family-involved healthy lifestyle intervention. Finally, the protocol will be undertaken on children with asthma aged 10-15, by using an experimental (pretest-posttest) design with repeated follow-ups. The research subjects will be randomly assign to condition of receiving intervention or control; the measurement of the outcome across 4 observations, to assess both group differences (experimental comparison), and changes within groups. The interventions consist of healthy diet (X1), regular exercise (X2), and booster energy balance-related behaviors (BEBRB) (X3). The observations start from baseline (O1), then have three observations (O2, O3, O4) at 3-month interval respectively. Outcome indicators include height, body weight, waist circumference as well as healthy life style modification present by diet record, exercise diary, healthy life environments. The research subjects will consist of randomly sampled school-age children and their fathers (or mothers), school teachers and school nurses. The approximate sample size is estimated by power analysis and dropout rate, the eligible sample size will be 200 and 160 pairs of children with their parents, school teachers and nurses in the first and third year respectively.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

Background: Childhood obesity is a global "public health crisis" with increasing prevalence rate in all racial, ethnic and gender groups, as well as across socioeconomic strata. Research findings indicate that over the past 30 years, the prevalence of chronic conditions in children and youths has increased. Childhood obesity impacts physical, psychological and social well-being, and also impacts the economy as well.

Purpose: The purpose of this study is to explore the healthy status, healthy lifestyles among school-age obese children of chronic conditions, then to examine the contextual factors affecting their healthy lifestyles, in order to develop a theory-informed and evidence-based intervention of school-based and family-involved intervention for obese children, and evaluate the effectiveness of interventions by using mixed methods (MM) research approach.

Methods: This study will be a three-year mixed methods study, including the identification of obesity issues among children with chronic conditions in the first phase study (2013/10/01-2014/07/31), development of an intervention protocol in the second phase study (2014/08/01-2015/07/31), and conduction/evaluation of an intervention of lifestyle intervention in the third phase study (2015/08/01-2016/07/31). Firstly, anthropometry, healthy lifestyles questionnaire survey on children aged 7-12 and school environment audit will be conducted. By using the literature review, meta-analysis and focus-research approaches to develop a healthy lifestyle intervention protocol in the second year program. The protocol will be tested on a sample of school-age children with asthma, to develop a school-based and family-involved healthy lifestyle intervention. Finally, the protocol will be undertaken on children with asthma aged 10-15, by using an experimental (pretest-posttest) design with repeated follow-ups. The research subjects will be randomly assign to condition of receiving intervention or control; the measurement of the outcome across 4 observations, to assess both group differences (experimental comparison), and changes within groups. The interventions consist of healthy diet (X1), regular exercise (X2), and booster energy balance-related behaviors (BEBRB) (X3). The observations start from baseline (O1), then have three observations (O2, O3, O4) at 3-month interval respectively. Outcome indicators include height, body weight, waist circumference as well as healthy life style modification present by diet record, exercise diary, healthy life environments. The research subjects will consist of randomly sampled school-age children and their fathers (or mothers), school teachers and school nurses. The approximate sample size is estimated by power analysis and dropout rate, the eligible sample size will be 200 and 160 pairs of children with their parents, school teachers and nurses in the first and third year respectively.

Expected outcomes: To recognize the risk factors and determinants, have an evidence-based development of school-based and family-involved lifestyle modification to better health outcomes for children with chronic conditions.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

200

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

      • Taipei, Taiwán
        • Reclutamiento
        • National Taiwan University
        • Contacto:
          • Bih-Shya Gau, Ph.D
          • Número de teléfono: 88440 886+23123456
          • Correo electrónico: bsgau@ntu.edu.tw

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

7 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • 7~15years old child
  • 7~15years old child's caregiver
  • 7~15years old child's teacher
  • 7~15years old child's nurse

Exclusion Criteria:

  • not 7~15years old child
  • not 7~15years old child's caregiver
  • not 7~15years old child's teacher
  • not 7~15years old child's nurse

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: Prevención
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: lifestyle intervention
the intervention strength (amount, frequency, duration) including a reduction in energy intake and an increase in physical activity level will be reported. The guidance/description of the treatment protocol, preparation and training of intervener, techniques to retain the research subjects will be covered to prevent the lack of intervention integrity. Besides, the schooler admitted in a university hospital will be invited to explore their health lifestyles and receive the intervention.
the intervention strength (amount, frequency, duration) including a reduction in energy intake and an increase in physical activity level will be reported. The guidance/description of the treatment protocol, preparation and training of intervener, techniques to retain the research subjects will be covered to prevent the lack of intervention integrity. Besides, the schooler admitted in a university hospital will be invited to explore their health lifestyles and receive the intervention.
Otros nombres:
  • amount, frequency, duration intervention

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
the body weight and height to calculate the body mass index (BMI)
Periodo de tiempo: evaluate after intervention in 3 months
evaluate after intervention in 3 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Bih-Shya Gau, PhD, National Taiwan University Hospital

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

1 de noviembre de 2013

Finalización primaria (Anticipado)

1 de julio de 2016

Finalización del estudio (Anticipado)

1 de julio de 2016

Fechas de registro del estudio

Enviado por primera vez

13 de noviembre de 2013

Primero enviado que cumplió con los criterios de control de calidad

13 de noviembre de 2013

Publicado por primera vez (Estimar)

19 de noviembre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

29 de mayo de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

27 de mayo de 2014

Última verificación

1 de mayo de 2014

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 201309023

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. .

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