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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04628897
• Other study ID #: 1000057061
• Status: Completed
• Start date: September 17, 2017
• Est. completion date: December 9, 2017

Study information

• Verified date: November 2020
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 9, 2017
• Est. primary completion date: December 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 34 Months to 38 Months

Eligibility

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.).

Related Conditions & MeSH terms

• Anemia
• Malnutrition
• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• Exposures
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).

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
The Hospital for Sick Children	International Centre for Diarrhoeal Disease Research, Bangladesh, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Moderate-to-Vigorous Physical Activity	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