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Completed

NCT Number: NCT04628897

Physical Activity and the Home Environment in Preschool-aged Children in Urban 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.

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Key information

Age range

34 month–38 month

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Exposures

Behavioral
  • Total area of available floor space inside the home (m2)
  • Frequency that child plays outdoors
  • Total number of physical hazards in the home (presence of open stairwells, stove height)
  • Total number of fine-motor activity items available to the child
  • Presence of gross-motor activity items available to the child across each category (e.g., fixed, portable: ball equipment, push/pull equipment, riding equipment, rocking and twisting equipment)
  • Hemoglobin concentration (g/L).

Primary outcomes

  1. Moderate-to-Vigorous Physical Activity

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh
  • University of Toronto

Registry information

Official study title

Risk Factors for Low Physical Activity Levels in Preschool-aged Children in a Densely Populated Urban Community in Bangladesh

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 16, 2020
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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