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CTRI Number  CTRI/2024/11/076928 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 09/12/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Movement Behaviours in early years 
Scientific Title of Study   The SUNRISE Study-International Study of 24-Hour Movement Behaviours in the Early Years 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Himangi Lubree 
Designation  Senior Scientist  
Affiliation  Vadu Rural Health Program, KEM Hospital Research centre  
Address  KEM Hospital Research Centre, 3rd floor TDH building, Moodliyar Road, Rasta Peth, Pune

Pune
MAHARASHTRA
411011
India 
Phone  9850503967  
Fax    
Email  himangi.lubree@kemhrcvadu.org  
 
Details of Contact Person
Scientific Query  
Name  Himangi Lubree 
Designation  Senior Scientist  
Affiliation  Vadu Rural Health Program, KEM Hospital Research centre  
Address  KEM Hospital Research Centre, 3rd floor TDH building, Moodliyar Road, Rasta Peth, Pune


MAHARASHTRA
411011
India 
Phone  9850503967  
Fax    
Email  himangi.lubree@kemhrcvadu.org  
 
Details of Contact Person
Public Query  
Name  Himangi Lubree 
Designation  Senior Scientist  
Affiliation  Vadu Rural Health Program, KEM Hospital Research centre  
Address  KEM Hospital Research Centre, 3rd floor TDH building, Moodliyar Road, Rasta Peth, Pune


MAHARASHTRA
411011
India 
Phone  9850503967  
Fax    
Email  himangi.lubree@kemhrcvadu.org  
 
Source of Monetary or Material Support  
Canadian Institutes of Health Research (CIHR) 160 Elgin Street, 10th Floor Address Locator 4809A Ottawa ON K1A 0W9 Canada 
 
Primary Sponsor  
Name  Canadian Institute of Health Research 
Address  160 Elgin Street, 10th Floor Address Locator 4809A Ottawa ON K1A 0W9 Canada 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Himangi Lubree  Vadu Rural Health Program  Vadu Rural Health Program KEM Hospital research Centre,Vadu, Shirur
Pune
MAHARASHTRA 		 9850503967

himangi.lubree@kemhrcvadu.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KEM Hospital Research Centre Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  3-5 year old normal healthy children 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Children 3 - 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.  
 
ExclusionCriteria 
Details  The parent/primary caregiver and/or child participant is unable to fluently
communicate in at least one Official Language (English or Marathi or Hindi)  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study will improve our
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
and culturally specific aspects of children’s movement behaviours and development. Improving our
understanding of the “Goldilocks Day” of movement behaviours for children’s development will also
greatly assist future public health guidelines development and intervention targets. The work will provide
novel evidence on guideline adherence, and on the Goldilocks Day and the extent to which it varies by
population/setting and health/developmental outcome. This evidence will be essential to design future
research and policy-based interventions aiming to improve early child health and development globally. 		 3 to 5 yr old children  
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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. 
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