Child DevelopmentNCT05778669
KeySteps@JC Phase One Follow-up Study
An observational study of Child Development, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Monitoring of medical, health and psychosocial conditions
- How many people
- 1,486 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2023to 31 Mar 2028
- 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 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: All cohort subjects of "KeySteps Phase One Study" [KeySteps@JC - Early Child Intervention (KSJC)] will be invited for this follow-up study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong, 000000
Patrick IP, MBBS, MPH, +852 2255 4090, patricip@hku.hk
About this study
Official title: Early Childhood Intervention to Reduce Deficits of Underprivileged Children - Follow-up Study
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.
Read the detailed description
Emerging evidence suggests that childhood is a sensitive period during which socioeconomic conditions become biologically embedded despite current circumstances during adulthood. Children with socioeconomic disadvantages are vulnerable to numerous health problems later in life, including cardiovascular and respiratory diseases. In both children and adults, the associations between socioeconomic status (SES) and life outcomes are monotonic or graded, such that individuals higher in the socioeconomic hierarchy enjoy better health status and well-being than those individuals one level below.
Socioeconomic disparities in developmental trajectories can be observed in the early years of life and this has necessitated a closer look at the childhood family environment. Families who are confronting socioeconomic struggles also tend to have higher levels of conflict, harsh restrictive parenting styles, chaotic or neglectful parenting, as well as inadequate emotional nurturing. Children reared in family environments marked by these adverse social conditions also tend to show elevated physiological responses to stress.
Continued urban development in Hong Kong has led to a simultaneous increase in economic indices, but also widen the socioeconomic gaps between social groups. Parallel to epidemiological patterns in other countries, the Child Health Survey documented that children from low SES families in Hong Kong were also more likely to suffer from worse physical and psychological health. Early sleep deprivation and overuse of digital devices were also more prevalent among the lower social class which resulted in problematic behaviour and learning.
The original project ("KS Phase One Study") focused on bridging the gap between students from privileged and underprivileged families. Results showed that there were improvements in school readiness and holistic development of children of the underprivileged children during their kindergarten stage. The promising findings worth further follow up to study the long-term benefits and sustainable effects, if any, in different dimensions of child development in longer term. The proposed follow-up study will recruit those subjects who had joined the original study "KS Phase One Study" as main cohort in the 32 Project schools in Sham Shui Po and Tin Shui Wai previously. Most families in those areas were with lower SES.
The hypothesis of the study is early interventions to children, families and schools during the kindergarten stage will have positive effects on shaping the trajectories in children and their families during the primary school stage. Questionnaires will be used collect information including children's health and psychosocial conditions, academic performance, and family demographics. Children general physical health and learning assessments will be carried out on-site. Their medical and health-related events will be tracked through the existing health care system.
Since all assessments used in this study are non-invasive, there should be no foreseeable major safety concern to the study subjects. Should there be unanticipated problems involving risk to study subjects or others or severe adverse events, they will be reported to the Research Ethics Committee responsible for overseeing this study (Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster) according to the set guidelines.
The analysis plan will be guided by the research aims and the hypothesis. Categorical data will be summarised with counts (percentages), continuous data with normal distribution will be summarised with mean (standard deviation [SD]) and median (interquartile or entire range) will be reported for other continuous data. Independent variables will be screened for statistically significance with the outcomes measured prior to conducting multilevel and multivariate regression analyses.
The Principal Investigator is responsible for ensuring data obtained from this research is accurate, complete and reliable. All information and data collected throughout the course of this study will remain strictly confidential to the research team members and will be used solely for research purposes. Identifiable information (e.g. names and identity card numbers) will be kept confidential and data collected in this study will be password-protected and restricted to designated research personnel. Personal records, to the extent of the applicable laws and regulations, will not be made publicly available. In the event of any report, presentation and/or publication of findings regarding this study, subjects' identity will not be disclosed. This study will be conducted in compliance with the protocol, Declaration of Helsinki and other applicable regulatory requirements.
- Conditions
- Child Development
- Being tested
- Monitoring of medical, health and psychosocial conditions
- Keywords
- Community child health, Child development, Motor performance, Nutrition, Physical activity, Sleep, KeySteps, Long term benefits, Sustainable effects
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort Group: Longitudinal follow-up intervention | Monitoring of medical, health and psychosocial conditions through questionnaires, on-site assessments and medical record checking. Receives: Other: Monitoring of medical, health and psychosocial conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 years
Nutritional status of the children
Assessing the nutritional status and dietary habits with the food frequency questionnaire (electronic version)
Measured: 5 years
Activity and sleep condition of the children
Assessing the physical activity level and sleep duration with the activity monitoring device (Actigraph)
Measured: 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).
Measured: 5 years
Secondary outcomes (2)
Parent Well-Being and Coping
The Parental Stress Scale (PSS) and questions on perceived financial strain will be used to assess the stress level of parents.
Measured: 5 years
Family Functioning
The Chinese Parent-Child Conflicts Tactic Scale (CTSPC) and questions related to parental involvement in children's education will be used to assess family functioning.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start1 Mar 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (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 The University of Hong KongThe 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
- 1,486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick IP, MBBS, MPH, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778669
- Sponsor's protocol ID
- KeySteps@JC 1.0 FU
- Status last verified
- Jun 2023
- First submitted
- 19 Feb 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Childhood Intervention to Reduce Deficits of Underprivileged Children - Follow-up Study
- ClinicalTrials.gov ID
- NCT05778669
- Acronym / sponsor ID
- KeySteps@JC 1.0 FU
- Conditions
- Child Development
- Keywords
- Community child health, Child development, Motor performance, Nutrition, Physical activity, Sleep, KeySteps, Long term benefits
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,486 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 21 Mar 2023 (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.
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.
Detailed description
Emerging evidence suggests that childhood is a sensitive period during which socioeconomic conditions become biologically embedded despite current circumstances during adulthood. Children with socioeconomic disadvantages are vulnerable to numerous health problems later in life, including cardiovascular and respiratory diseases. In both children and adults, the associations between socioeconomic status (SES) and life outcomes are monotonic or graded, such that individuals higher in the socioeconomic hierarchy enjoy better health status and well-being than those individuals one level below.
Socioeconomic disparities in developmental trajectories can be observed in the early years of life and this has necessitated a closer look at the childhood family environment. Families who are confronting socioeconomic struggles also tend to have higher levels of conflict, harsh restrictive parenting styles, chaotic or neglectful parenting, as well as inadequate emotional nurturing. Children reared in family environments marked by these adverse social conditions also tend to show elevated physiological responses to stress.
Continued urban development in Hong Kong has led to a simultaneous increase in economic indices, but also widen the socioeconomic gaps between social groups. Parallel to epidemiological patterns in other countries, the Child Health Survey documented that children from low SES families in Hong Kong were also more likely to suffer from worse physical and psychological health. Early sleep deprivation and overuse of digital devices were also more prevalent among the lower social class which resulted in problematic behaviour and learning.
The original project ("KS Phase One Study") focused on bridging the gap between students from privileged and underprivileged families. Results showed that there were improvements in school readiness and holistic development of children of the underprivileged children during their kindergarten stage. The promising findings worth further follow up to study the long-term benefits and sustainable effects, if any, in different dimensions of child development in longer term. The proposed follow-up study will recruit those subjects who had joined the original study "KS Phase One Study" as main cohort in the 32 Project schools in Sham Shui Po and Tin Shui Wai previously. Most families in those areas were with lower SES.
The hypothesis of the study is early interventions to children, families and schools during the kindergarten stage will have positive effects on shaping the trajectories in children and their families during the primary school stage. Questionnaires will be used collect information including children's health and psychosocial conditions, academic performance, and family demographics. Children general physical health and learning assessments will be carried out on-site. Their medical and health-related events will be tracked through the existing health care system.
Since all assessments used in this study are non-invasive, there should be no foreseeable major safety concern to the study subjects. Should there be unanticipated problems involving risk to study subjects or others or severe adverse events, they will be reported to the Research Ethics Committee responsible for overseeing this study (Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster) according to the set guidelines.
The analysis plan will be guided by the research aims and the hypothesis. Categorical data will be summarised with counts (percentages), continuous data with normal distribution will be summarised with mean (standard deviation [SD]) and median (interquartile or entire range) will be reported for other continuous data. Independent variables will be screened for statistically significance with the outcomes measured prior to conducting multilevel and multivariate regression analyses.
The Principal Investigator is responsible for ensuring data obtained from this research is accurate, complete and reliable. All information and data collected throughout the course of this study will remain strictly confidential to the research team members and will be used solely for research purposes. Identifiable information (e.g. names and identity card numbers) will be kept confidential and data collected in this study will be password-protected and restricted to designated research personnel. Personal records, to the extent of the applicable laws and regulations, will not be made publicly available. In the event of any report, presentation and/or publication of findings regarding this study, subjects' identity will not be disclosed. This study will be conducted in compliance with the protocol, Declaration of Helsinki and other applicable regulatory requirements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort Group: Longitudinal follow-up intervention | – | Other: Monitoring of medical, health and psychosocial conditionsMonitoring of medical, health and psychosocial conditions through questionnaires, on-site assessments and medical record checking. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All cohort subjects of "KeySteps Phase One Study" [KeySteps@JC - Early Child Intervention (KSJC)] will be invited for this follow-up study.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring of medical, health and psychosocial conditionsQuestionnaires 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. | Other | Cohort Group: Longitudinal follow-up intervention |
Primary outcome
Growth and development of the children
Time frame: 5 years
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).
Nutritional status of the children
Time frame: 5 years
Assessing the nutritional status and dietary habits with the food frequency questionnaire (electronic version)
Activity and sleep condition of the children
Time frame: 5 years
Assessing the physical activity level and sleep duration with the activity monitoring device (Actigraph)
Psychosocial development of the children
Time frame: 5 years
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).
2 secondary outcomes
Parent Well-Being and Coping
Time frame: 5 years
Family Functioning
Time frame: 5 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 9 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Patrick IP, MBBS, MPH principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development, run by The University of Hong Kong at 1 site in Hong Kong.
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 4 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: looking for participants now, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Patrick IP, MBBS, MPH (+852 2255 4090, patricip@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth and development of the children (time frame: 5 years). The study lists 4 primary outcomes in all. 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 9 Jun 2023.