NCT05778669

Brief Summary

This proposed study is a 5-year follow-up study of "KeySteps Phase One Study", which focused on bridging the gap between students from privileged and underprivileged families. This study will investigate the long-term effects of early childhood interventions provided during the kindergarten stage on primary school children and their families and track the health conditions and development of the Project children in their primary school stage. Cohort students of "KeySteps Phase One Study" will be invited to join this follow-up study. Data including children's health and psychosocial conditions, academic performance, and family demographics will be collected. In addition, subjects will receive on-site assessments on general health and learning. Medical and health-related events of subjects will be tracked through the existing health care system.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,486

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress63%
Mar 2023Mar 2028

First Submitted

Initial submission to the registry

February 19, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

June 9, 2023

Status Verified

June 1, 2023

Enrollment Period

4.8 years

First QC Date

February 19, 2023

Last Update Submit

June 7, 2023

Conditions

Child Development

Keywords

Community child healthChild developmentMotor performanceNutritionPhysical activitySleepKeyStepsLong term benefitsSustainable effects

Outcome Measures

Primary Outcomes (4)

  • Growth and development of the children

    Children's body height, weight, blood pressure, body fat and physical performance (cardiorespiratory endurance, muscle strength and endurance, flexibility according to the Hong Kong Education Bureau School Physical Fitness Award Scheme guidelines).

    5 years

  • Nutritional status of the children

    Assessing the nutritional status and dietary habits with the food frequency questionnaire (electronic version)

    5 years

  • Activity and sleep condition of the children

    Assessing the physical activity level and sleep duration with the activity monitoring device (Actigraph)

    5 years

  • Psychosocial development of the children

    Different scales will be used to assess the child's psychosocial development namely the Strength and Difficulties Questionnaire (SDQ), Paediatric Quality of Life (PQoL), Chinese Strengths and Weaknesses of Attention Deficit Hyperactivity Disorder Symptoms and Normal Behaviour Scale (SWAN).

    5 years

Secondary Outcomes (2)

  • Parent Well-Being and Coping

    5 years

  • Family Functioning

    5 years

Study Arms (1)

Cohort Group: Longitudinal follow-up intervention

Monitoring of medical, health and psychosocial conditions through questionnaires, on-site assessments and medical record checking.

Other: Monitoring of medical, health and psychosocial conditions

Interventions

Monitoring of medical, health and psychosocial conditionsOTHER

Questionnaires will be used to collect information including children's health and psychosocial conditions, academic performance, and family demographics. On-site assessments including general health and learning assessments. Tracking of medical and health-related events of participants will be performed through the existing health care system.

Cohort Group: Longitudinal follow-up intervention

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All cohort subjects of "KeySteps Phase One Study" \[KeySteps@JC - Early Child Intervention (KSJC)\] will be invited for this follow-up study.

You may qualify if:

  • Children and their families of the KS Phase One Study cohort in Academic Year 2018-19
  • Children and their families are willing to join this follow-up study

You may not qualify if:

  • Children and their families withdrew themselves from KS Phase One Study (KeySteps@JC - Early Child Intervention (KSJC) previously
  • Children cannot understand Chinese
  • Children's parents cannot understand Chinese
  • Children who are not studying primary schools in Hong Kong

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, 000000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Health

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Patrick IP, MBBS, MPH

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick IP, MBBS, MPH

CONTACT

+852 2255 4090patricip@hku.hk

Amy CHEUNG, BN, MSc

CONTACT

+852 3513 3197ahkcheun@hku.hk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2023

First Posted

March 21, 2023

Study Start

March 1, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

June 9, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)