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Clinical Trials/CTRI/2024/11/076928
CTRI/2024/11/076928RecruitingNot Applicable

The SUNRISE Study-International Study of 24-Hour Movement Behaviours in the Early Years

Canadian Institute of Health Research1 site in 1 country1,000 target enrollmentStarted: November 30, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
1,000
Locations
1
Primary Endpoint
The study will improve our

Study Overview

Brief Summary

Background and Importance: The early years (0-5 years) is a critical and sensitive period for lifelong development, as key experiences or missed experiences can alter a child’s developmental potential. Thus, international efforts have focused on ensuring children <5 years are developmentally on track (UN SDG: 4.2.1; WHO Ending Childhood Obesity Report). Unfortunately, our understanding of childhood development is limited and predominantly informed by research on children from high-income countries and urban settings. One set of exposures with potential benefits to childhood development are physical activity, sedentary behaviour, and sleep—collectively termed movement behaviours— but are understudied worldwide. While the benefits to children’s lifelong development from single movement behaviours (e.g. physical activity) has been demonstrated, little is known about the ideal distribution or composition of movement behaviours in a 24-hour day for optimal development. Further, this lack of information is particularly pronounced in rural settings and low- and middle-income countries (LMIC), exacerbating already existing global inequities. Goal: Our goal is to explore movement behaviours (combined and integrated physical activity, sedentary behaviour, sleep) and examine the relationships between movement behaviours and physical, cognitive, and social-emotional development in urban and rural children. Methods: We will each recruit 1,000 children aged 3.0-4.9 years with equal representations by sex and rural-urban communities (500 for each), through stratified sampling. Movement behaviours will be measured using ActiGraph accelerometers that have demonstrated robust psychometrics and feasibility, worn on the waist 24 hours/day for 5 days. Primary caregivers will complete questionnaires to assess children’s screen time, sleep routines and family sociodemographic characteristics. Development will encompass physical (body mass index z-scores, gross motor skills, and fine motor skills), cognitive (response inhibition, visual-spatial working memory, general knowledge, and language development), and social-emotional (internalizing, externalizing, prosocial behaviours, communication skills, social competence, and emotional maturity) development. Expected Outcomes:  The examination will improve our understanding in rural and LMICs, ultimately leading to a richer, more global and equitable understanding of the universal and culturally specific aspects of children’s movement behaviours and development.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
3.00 Year(s) to 5.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 5 years old. Only one child from each primary caregiver may participate. If multiple eligible children from one primary caregiver want to participate, the alphabetically first eligible child will be selected to participate.

Exclusion Criteria

  • The parent/primary caregiver and/or child participant is unable to fluently communicate in at least one Official Language (English or Marathi or Hindi).

Outcomes

Primary Outcomes

The study will improve our

Time Frame: 3 to 5 yr old children

understanding regarding movement behaviours in 3 to 5 yr old children in rural areas and in LMICs, ultimately leading to a richer understanding of the universal

Time Frame: 3 to 5 yr old children

and culturally specific aspects of children’s movement behaviours and development. Improving our

Time Frame: 3 to 5 yr old children

understanding of the “Goldilocks Day” of movement behaviours for children’s development will also

Time Frame: 3 to 5 yr old children

greatly assist future public health guidelines development and intervention targets. The work will provide

Time Frame: 3 to 5 yr old children

novel evidence on guideline adherence, and on the Goldilocks Day and the extent to which it varies by

Time Frame: 3 to 5 yr old children

population/setting and health/developmental outcome. This evidence will be essential to design future

Time Frame: 3 to 5 yr old children

research and policy-based interventions aiming to improve early child health and development globally.

Time Frame: 3 to 5 yr old children

Secondary Outcomes

  • Will provide information on the number of children complying to the WHO global guidelines of movement behaviours in 3 to 5 year old children(3 to 5 yrs)

Investigators

Sponsor
Canadian Institute of Health Research
Sponsor Class
Research institution
Responsible Party
Principal Investigator
Principal Investigator

Himangi Lubree

Vadu Rural Health Program, KEM Hospital Research centre

Study Sites (1)

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