NCT06532669

Brief Summary

The purpose of this study was to develop a children's active health index based on the three main factors-the environment, lifestyle, and the physiological and behavioral traits of children of various ages. To acquire dynamic data, a prospective cohort research was carried out. Construct a dynamic digital health portrait to detect and warn children's health problems early, intervene in a timely manner, and explore a new paradigm of children's active health management.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
1,435

participants targeted

Target at P75+ for all trials

Timeline
50mo left

Started Jul 2024

Longer than P75 for all trials

Status
not yet 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 Progress31%
Jul 2024Jul 2030

Study Start

First participant enrolled

July 1, 2024

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

August 1, 2024

Status Verified

May 1, 2024

Enrollment Period

5 years

First QC Date

July 30, 2024

Last Update Submit

July 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Child Health Index

    Child Health Index serves as a comprehensive metric to evaluate and measure how children actively maintain, promote, and enhance their own health status through positive lifestyles and healthy behaviors, with the goal of preventing the onset of diseases and delaying their progression. This index encompasses multiple aspects, such as children's dietary habits, exercise routines, sleep quality, and mental health status.

    0-6 years

Secondary Outcomes (1)

  • Subitem Child Health Index

    0-6 years

Study Arms (7)

Fetal period

from the formation of the fertilized egg until before birth, approximately 40 weeks

Neonatal period

from the beginning of umbilical cord ligation after birth to 28 days

Infancy period

after neonatal to 1 year of age.

Early childhood

from 1 year old to before 3 years old.

Pre-school age

from three years old to six years old before entering primary school

School age

from the age of 6 to the age of 12

Puberty

from the age of 12 to the age of 18

Eligibility Criteria

AgeUp to 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The target study participants were children aged 0-18 years.

You may qualify if:

  • Age≤ 18 years old, regardless of gender.
  • Subject and/or guardian agrees to participate in this trial and signs the informed consent form.

You may not qualify if:

  • The investigator judged that the subject had poor compliance and was unable to complete the study as required.
  • Inability to understand the investigator's presentation or description of this trial.
  • Other conditions judged by the investigator to be unsuitable for participating in the trial, such as: acute trauma, critical condition, restlessness of the subject, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Xin Sun, MD

    Xinhua Hospital, Shanghai J iao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 1, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2030

Last Updated

August 1, 2024

Record last verified: 2024-05