Physical Activity and the Home Environment in Preschool-aged Children in Urban Bangladesh
13 de noviembre de 2020 actualizado por: Daniel Roth, The Hospital for Sick Children
Risk Factors for Low Physical Activity Levels in Preschool-aged Children in a Densely Populated Urban Community in Bangladesh
The overall goal of this study is to generate new knowledge regarding the nutritional and environmental determinants of physical activity in young children living in a densely populated urban community in Bangladesh.
The investigators hypothesize that low levels of preschooler physical activity are associated with a lack of play-oriented physical attributes (i.e., total area of indoor floor space, presence and count of unsafe physical hazards, and presence and count of stationary and portable gross motor activity-oriented items) within the homes in urban Bangladesh.
The investigators also hypothesized that low Hb may be associated with low physical activity levels in this population.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Study Rationale
As the double burden of nutrition emerges in Bangladesh and other low- to middle-income countries, it is imperative to develop strategies to mitigate the adverse effects associated with both undernutrition and obesity. Identifying levels of physical activity among children is a requisite step to developing and targeting interventions to promote physical activity among young populations. Furthermore, exploring the risk factors associated with physical activity levels in young children can help better inform policy makers surrounding a public health intervention.
Goals The overall goal of the research is to generate new knowledge regarding the nutritional and environmental determinants of physical activity in young children living in a densely populated urban community in Bangladesh.
Primary Objectives
The specific objectives of this study are to:
- Describe physical activity levels in a sample of preschool-aged children in an inner-city community in Dhaka, Bangladesh,
- Estimate the associations between characteristics of the physical environment of the home (total area of available floor space inside of the home, number and presence of physical hazards, and the number of gross motor activity-oriented items present) and the physical activity levels of preschoolers in Dhaka, and
- Estimate the associations between hemoglobin concentration (Hb) and preschooler physical activity level.
- Describe sleep quantity and quality in the sample of preschool-aged children in urban Bangladesh
The investigators conducted a cross-sectional observational study of preschool-aged children between 34-38 months of age (n=60) selected from the ongoing Maternal Vitamin D for Infant Growth (MDIG) trial cohort (NCT01924013) in Dhaka, Bangladesh. The investigators planned to enrol a minimum of 60 participants with complete data sets, with recruitment up to 90 participants until this enrolment target was reached.
Study Procedures
- Accelerometry
- Home built environment audit
- Anthropometry
- hemoglobin concentration
- Maternal perception of the home environment and household food security
Tipo de estudio
De observación
Inscripción (Actual)
65
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
-
-
Ontario
-
Toronto, Ontario, Canadá, M5G 1X8
- The Hospital for Sick Children
-
-
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
2 años a 3 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Participants within the Maternal Vitamin D for Infant Growth (MDIG) trial (NCT01924013) cohort registry who have a) expressed interest in participating in future sub-studies, and b) have children within the target age range, will be contacted.
Participants will be contacted prior to their anticipated study visit.
A contact list will be updated each week to prospectively recruit participants in advance or during the age window in which children are eligible for enrolment.
Each list will begin with the eldest children to reduce the number of missed opportunities to enroll children before they exit the eligible age window.
The catchment area will include the following neighbourhoods in urban Dhaka: Kamrangir char, Azimpur, Lalbag, and Hazariba
Descripción
Inclusion Criteria:
- Child is 34-38 months of age;
- Child and primary caregiver reside in Dhaka or urban environs;
- Parent/guardian provides written informed consent for study procedures.
Exclusion Criteria:
- Child requires mobility assistance and/or has been diagnosed with a major neurological or orthopedic condition or disorder affecting physical activity (e.g., cerebral palsy, club foot, etc.).
- Major physician-diagnosed chronic respiratory or cardiac disease that limits physical activity (e.g., severe asthma, currently taking medication for symptomatic congenital heart disease, 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
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Moderate-to-Vigorous Physical Activity
Periodo de tiempo: 3-14 days
|
Objectively measured accelerometry data, a continuous variable reflecting mean daily PA during the study period, expressed as mean counts per 15 seconds (cp15s).
This summary measure was generated by first calculating mean daily PA, then averaging the daily means across collection days, including data between the time the child woke up until the time the child went to sleep, as reported by the caregiver on all days that met criteria for inclusion (i.e., at least 10 hours of wear time)
|
3-14 days
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
17 de septiembre de 2017
Finalización primaria (Actual)
9 de diciembre de 2017
Finalización del estudio (Actual)
9 de diciembre de 2017
Fechas de registro del estudio
Enviado por primera vez
9 de noviembre de 2020
Primero enviado que cumplió con los criterios de control de calidad
9 de noviembre de 2020
Publicado por primera vez (Actual)
16 de noviembre de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de noviembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
13 de noviembre de 2020
Última verificación
1 de noviembre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1000057061
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Details of the data sharing plan are still to be determined.
Marco de tiempo para compartir IPD
To be determined
Criterios de acceso compartido de IPD
To be determined
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
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. .