Child DevelopmentNCT06532669
Active Health Management for Children
An observational study of Child Development, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Child Development
- How many people
- 1,435 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
Study population: The target study participants were children aged 0-18 years.
Who may be able to join
- Age≤ 18 years old, regardless of gender.
- Subject and/or guardian agrees to participate in this trial and signs the informed consent form.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Child Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-6 years
Secondary outcomes (1)
Subitem Child Health Index
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.
Measured: 0-6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,435 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Sun, MD, Principal investigator, Xinhua Hospital, Shanghai J iao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532669
- Sponsor's protocol ID
- XH-24-004
- Status last verified
- May 2024
- First submitted
- 30 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore a New Paradigm of Active Health Management for Children Based on Health Index
- ClinicalTrials.gov ID
- NCT06532669
- Acronym / sponsor ID
- XH-24-004
- Conditions
- Child Development
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,435 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- The target study participants were children aged 0-18 years.
Key inclusion criteria (2 listed)
- Age≤ 18 years old, regardless of gender.
- Subject and/or guardian agrees to participate in this trial and signs the informed consent form.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Subitem Child Health Index
Time frame: 0-6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xin Sun, MD principal investigator
Xinhua Hospital, Shanghai J iao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Sun, MD (0086-021-25077480, sunxin@xinhuamed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Health Index (time frame: 0-6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.