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

November 13, 2020 updated by: 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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

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:

  1. Describe physical activity levels in a sample of preschool-aged children in an inner-city community in Dhaka, Bangladesh,
  2. 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
  3. Estimate the associations between hemoglobin concentration (Hb) and preschooler physical activity level.
  4. 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

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3-14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2017

Primary Completion (Actual)

December 9, 2017

Study Completion (Actual)

December 9, 2017

Study Registration Dates

First Submitted

November 9, 2020

First Submitted That Met QC Criteria

November 9, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 13, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 1000057061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Details of the data sharing plan are still to be determined.

IPD Sharing Time Frame

To be determined

IPD Sharing Access Criteria

To be determined

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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