NCT05652829

Brief Summary

Obesity in children is a priority of public health initiatives, and reliable obesity prevalence and severity assessments are needed for policy decisions and study directions. Obesity in childhood raises the risk of insulin resistance, type 2 diabetes, and cardiovascular diseases in later life. To develop preventive strategies, it is essential to identify modifiable lifestyle habits linked to childhood obesity. The four main modifiable lifestyle behaviors affecting body weight are physical activity, sleep, screen time, and eating patterns. Among these factors, sleep is a neglected issue for clinicians, and recent research has shown that sleep patterns can predict BMI and macronutrient intake. Getting enough sleep is essential to a person's physical and mental well-being and development. This study aims to determine the sleep duration and quality of children aged 9-12 during the school year and how sleep impacts food intake and choice. Also, determining any relationships between the sleep and food intake outcomes and screen time, physical activity, and anthropometric indicators.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

1 year

First QC Date

November 1, 2022

Last Update Submit

December 7, 2022

Conditions

Keywords

SleepFood choiceChildrenScreen timeActivity

Outcome Measures

Primary Outcomes (2)

  • Sleep duration and quality

    Questionnaires (sleep diary, Children's Sleep Habits Questionnaire, Epworth Sleepiness Scale for Children and Adolescents) and actigraphy (actigraphy is method of measuring human movement, activities and behaviours. It is normally worn on the wrist and measures temperature and environmental light as wellGENEActiv, Activinsights Ltd, Cambs, UK) will measure sleep parameters including total sleep time, bedtime, rise-time, sleep quality and efficiency, wake after sleep onset, sleep interruptions.

    Participants wear the actigraphy for seven days. When the researcher fits the participant with actigraphy, it collects data until seven days based on the researcher sitting. Participants will complete a sleep diary every day from the first day of study.

  • Energy and sugar consumption

    Two online 24-hour food recalls using Automated Self-Administered Dietary Assessment Tool(ASA24). ASA24 is a free web-based application that allows for numerous automatically coded self-administered 24-hour recalls and dietary records for epidemiologic, interventional, behavioural, or clinical research.

    During seven days study, each participant complete two-24 recalls hour with their parents help. One should be on a weekday, and the other on the weekend during the study.

Secondary Outcomes (2)

  • Physical activity levels

    Participants wear the actigraphy for seven days. When the researcher fits the participant with actigraphy, it collects data until seven days based on the researcher sitting. Participants will complete PAQ on the seventh day of the study.

  • Digital screen time

    Participants will complete questionnaire on the first day of the study.

Study Arms (1)

Children aged 9-12

We are recruiting 30 children aged 9-12 with one parent.

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The target population is recruited by advertising study directly and indirectly. Standard passive approaches are used, including flyers/posters on community bulletin boards, flyer handouts via afterschool programs, promotion on community radio stations, promotion via the Memorial University Newsline, and advertisements on research group websites and social media channels. Directed approaches are also used, including posting/messaging on age group-related parent Facebook groups with permission from group administrators, the Newfoundland and Labrador English School District are approached for permission to send information flyer out to all students in relevant grades in the St. John's and surrounding area.

You may qualify if:

  • Age: 9-12 years old
  • One parent or guardian should accompany the child.
  • A commitment to complete all the questionnaires daily for both children and parents
  • A commitment to wearing the actigraphy during seven days of study.

You may not qualify if:

  • Remove the watch during the week of study
  • Not completing two dietary recalls
  • Not completing forms and questionnaires
  • Being sick (e.g., Covid-19) during the week of study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition and Lifestyle Lab, Department of Earth Sciences, Memorial University of Newfoundland, 9 Arctic Ave

St. John's, Newfoundland and Labrador, A1B 3X5, Canada

RECRUITING

MeSH Terms

Conditions

Feeding BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Scott Harding

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott Harding

CONTACT

Scott Harding

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 1, 2022

First Posted

December 15, 2022

Study Start

February 1, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

December 15, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations