- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06532669
Active Health Management for Children
July 30, 2024 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Explore a New Paradigm of Active Health Management for Children Based on Health Index
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.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Under the guidance of the World Health Organization's (WHO) Global Strategy for Women's, Children's, and Adolescents' Health (2016-2030) and China's Child Development Programme (2021-2030), as well as the comprehension that the primary focus of medical care in the future will gradually shift from disease diagnosis and treatment to disease prevention and health management, this study will 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-and conduct a prospective child cohort study.
Gather multi-dimensional children cohort data from many sources (medical facilities, schools, families, and communities) that covers physiological indicators, behavioral habits, dietary record, and so on.
The meta-model of children's active health is built using ordinary differential equations in conjunction with digital intelligence technology, which enables real-time and all-around data collection, establishes dynamic digital health portraits for children, and dynamically monitors the health status of children as it varies over time and in response to environmental changes.
The ultimate goal of this approach is to identify and warn children's health problems early on, implement timely intervention, and ultimately investigate a new paradigm of children's active health management.
Study Type
Observational
Enrollment (Estimated)
1435
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xin Sun, MD
- Phone Number: 0086-021-25077480
- Email: sunxin@xinhuamed.com.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
The target study participants were children aged 0-18 years.
Description
Inclusion Criteria:
- Age≤ 18 years old, regardless of gender.
- Subject and/or guardian agrees to participate in this trial and signs the informed consent form.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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
|
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School age
from the age of 6 to the age of 12
|
|
Puberty
from the age of 12 to the age of 18
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Health Index
Time Frame: 0-6 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subitem Child Health Index
Time Frame: 0-6 years
|
Child Health Index is a comprehensive index comprised of multiple subitem child health index, designed to thoroughly capture children's performance across diverse health dimensions.
|
0-6 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xin Sun, MD, Xinhua Hospital, Shanghai J iao Tong University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2024
Primary Completion (Estimated)
July 1, 2029
Study Completion (Estimated)
July 1, 2030
Study Registration Dates
First Submitted
July 30, 2024
First Submitted That Met QC Criteria
July 30, 2024
First Posted (Actual)
August 1, 2024
Study Record Updates
Last Update Posted (Actual)
August 1, 2024
Last Update Submitted That Met QC Criteria
July 30, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- XH-24-004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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