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

NCT04628897 | Completed

• 1 other identifier: 1000057061
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity, Childhood; Malnutrition; Anemia

Keywords

Obesity; Home Environment; Malnutrition

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Exposures BEHAVIORAL

1. Total area of available floor space inside the home (m2) 2. Frequency that child plays outdoors 3. Total number of physical hazards in the home (presence of open stairwells, stove height) 4. Total number of fine-motor activity items available to the child 5. 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) 6. Hemoglobin concentration (g/L).

Eligibility Criteria

• Age: 34 Months - 38 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• University of Toronto: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Pediatric Obesity; Malnutrition; Anemia; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Daniel Roth

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 16, 2020
• Study Start: September 17, 2017
• Primary Completion: December 9, 2017
• Study Completion: December 9, 2017
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: To be determined
• Access Criteria: To be determined

Locations

CA (1)