Lifestyle ModificationNCT06113042
KeySteps@JC Phase Two Study
A study testing Health talks, learning packs, Lifestyle modification programme and School healthy environment evaluation in people with Lifestyle Modification, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This proposed 'KeySteps Phase Two Study' is a 5-year study, which aims to investigate the effectiveness and sustainability of a Community Child Health Model with different services related to healthy lifestyle programmes and health promotion implemented in community settings of deprived living areas. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lifestyle Modification
- What is being tested?
- Health talks, learning packs, Lifestyle modification programme and School healthy environment evaluation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,000 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2023to 31 Dec 2028
- Phase
- Interventional
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Children are studying in kindergartens which agree to join the project.
- Parent/legal guardian of the child consented the child's participation in to the study.
- Participants of the Lifestyle modification Programme should be K1 students in academic year 2023/24 of the selected kindergartens and their parents/guardians.
Who cannot join
- Parent/legal guardian of the child cannot understand Cantonese.
- Parent/legal guardian of the child cannot read Chinese.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Amy CHEUNG, BN, MSc contact
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Patrick IP, MBBS, MPH, +852 22554090
About this study
Official title: Effectiveness and Sustainability of a Community Child Health Model in Community Settings
This proposed 'KeySteps Phase Two Study' is a 5-year study, which aims to investigate the effectiveness and sustainability of a Community Child Health Model with different services related to healthy lifestyle programmes and health promotion implemented in community settings of deprived living areas. Potential participants are children studying or living in the five selected districts, namely Sham Shui Po, Yuen Long, Tuen Mun, Sha Tin and Kowloon City. Data including children's health and psychosocial conditions, and family demographics will be collected. In addition, subjects will receive on-site assessments on general health and development. Medical and health related events of subjects will be tracked through the existing health care system. Subjects will receive health promotion services and/or lifestyle modification programmes according to their needs.
Read the detailed description
With the improved economy and rapid growth of socio-economic activities, the socioeconomic gaps between social groups in Hong Kong are widening continuously. According to the Hong Kong Poverty Report of Oxfam Hong Kong (OHK), the richest decile of households made 34.3 times more than the poorest decile prior the COVID pandemic (2019), that number surged to 47.3 times by the first quarter of 2022.1 Similar to the experience in other countries, children from low socio-economic status (SES) families in Hong Kong are at higher risk of physical health, psychological and behavioural problems including obesity/overweight and hypertension, visual, behavioural and learning problems.
Major chronic diseases such as central obesity, hypertension, diabetes mellitus, ischemic heart disease, degenerative retinal and other eye diseases are found to be rooted in childhood related to unhealthy lifestyles, adverse thriving and nutritional environment. The COVID-19 pandemic has exaggerated the existing risks and led to emerging threats among young children, especially in disadvantaged families in Hong Kong in the past two years. With the stringent social isolation, school suspension and home confinement, children's physical health, developmental and behavioral problems have worsened. Experience in a local project, KeySteps@JC funded by HKJC 2017-2022 showed that children in deprived districts were susceptible to nutritional imbalance, physical inactivity and weight problems, especially during the COVID-19 period. Another study also reported the overuse of electronic devices in disadvantaged families. Several other studies also indicated that there were adverse health effects related to COVID-19 pandemic including obesity, deteriorated physical fitness, visual impairment in particular myopia, sleep and emotional disturbance, decreased school readiness, and increased risk of child maltreatment, inattention/hyperactivity and neurodevelopmental disorders, etc.
Lifestyle modification addresses the poor lifestyle choices that are the root causes of chronic diseases. The goal of the lifestyle modification programme is to empower the patient with knowledge, skills, and a desire to create and maintain new habits which are needed to manage their chronic disease and potentially eliminate the root cause. Parental or family involvement in interventions is found to be impactful on lifestyle changes in children, leading to favourable health outcomes. As a result of modelling their parents' behaviour, children are more likely to adopt a healthy lifestyle if their parents demonstrate healthy lifestyle behaviours. Research also found that parents perceived social support to be a key enabler for children to eat healthfully and be active. Group-based health interventions may encourage the building of peer support with additional benefits of social support in the community.
Although lifestyle modification programmes seem promising to address the increasing need of young children, they have not been widely implemented in early childhood public health settings as a main health promotion and disease prevention strategy. This research is to investigate the effectiveness and sustainability of a Community Child Health Model with different services related to healthy lifestyle programmes and health promotion implemented in community settings of deprived living areas.
Potential participants are children studying or living in the five selected districts, namely Sham Shui Po, Yuen Long, Tuen Mun, Sha Tin and Kowloon City. Those districts shared some common disadvantaged backgrounds such as families with lower socio-economic status, mostly living in subdivided units and crowded housing, insufficient public play area and early childhood services. According to the Hong Kong Poverty Situation Report from Census and Statistics Department in 2018, Yuen Long ranked 2nd highest, Tuen Mun 4th, Sham Shui Po 5th, Sha Tin 6th and Kowloon City 9th in terms of 0-6 years old child living in poverty population.11 Moreover, Sham Shui Po was the second-highest district with subdivided units12and Kowloon City ranked third in terms of the number of partitioned flats and second-lowest districts in the public play space area managed by Leisure and Cultural Services Department (LCSD).
This study will be conducted in compliance with the protocol, Declaration of Helsinki and other applicable regulatory requirements.
- Conditions
- Lifestyle Modification
- Being tested
- Health talks, learning packs, Lifestyle modification programme, School healthy environment evaluation
- Keywords
- Community child health, Child development, Nutrition, Physical activity, Sleep, Healthy lifestyle, Lifestyle modification, KeySteps
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health talks, learning packsBehavioural
All participants can join the health talks and receive the learning packs.
Lifestyle modification programmeBehavioural
In Group 1: The programme includes both knowledge and activity/practicum sessions for children and parents. It will be carried out in district community hubs.
Group 2: The programme focuses on the knowledge sessions for parents. It will be carried out in schools.
Group 3: The programme focuses on the activity/practicum sessions for children and parents. It will be carried out in district community hubs.
School healthy environment evaluationBehavioural
Evaluation on school healthy environment will be carried out in Group 1 and Group 2 to enhance the schools to provide a healthy school environment to children.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive support (Group 1) | Experimental | Comprehensive health support will be performed both in district community hub and school. Interventional services include heath talks, learning packs, hub-based comprehensive lifestyle modification programme, school healthy environment evaluation. Receives: Behavioral: Health talks, learning packs; Behavioral: Lifestyle modification programme; Behavioral: School healthy environment evaluation |
| School-based support (Group 2) | Experimental | Interventional services will be performed in school only, including heath talks, learning packs, school-based lifestyle modification programme, school healthy environment evaluation. Receives: Behavioral: Health talks, learning packs; Behavioral: Lifestyle modification programme; Behavioral: School healthy environment evaluation |
| District-based support (Group 3) | Experimental | Interventional services will be performed in community hub only, including heath talks, learning packs, hub-based lifestyle modification programme. Receives: Behavioral: Health talks, learning packs; Behavioral: Lifestyle modification programme |
| Control (Group 4) | Placebo comparator | Limited services will be provided including health talks and learning packs. Receives: Behavioral: Health talks, learning packs |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
Assessing children's body weight (kg) to check for overweight or underweight.
Measured: 5 years
Physical activity level
Assessing the physical activity intensity and duration (minutes) with the activity monitoring device (Actigraph).
Measured: 5 years
Nutritional status
Assessing the nutritional status and dietary habits with the food frequency questionnaire (electronic version). The frequency and quantity of food intake will be recorded. The consumption of different kinds of nutrients will be calculated and compared with the reference levels to determine the adequacy.
Measured: 5 years
Use of electronic devices
Assessing the duration of daily use of electronic devices.
Measured: 5 years
Parental awareness
Assessing changes on parent's knowledge, attitudes and practices on child healthy lifestyle by a questionnaire. A 5-point scale is adopted. The higher the score, the better the result.
Measured: 5 years
Secondary outcomes (1)
Feedback evaluation
Obtaining the programme feedback from stakeholders on the project health service by a feedback questionnaire. A 6-point scale is adopted. The higher the score, the better the result.
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 posted2 Nov 2023
- Study start1 Nov 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lifestyle ModificationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick IP, MPH, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113042
- Sponsor's protocol ID
- KeySteps@JC 2.0
- Status last verified
- Aug 2023
- First submitted
- 3 Oct 2023
- Last updated
- 26 Dec 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 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Sustainability of a Community Child Health Model in Community Settings
- ClinicalTrials.gov ID
- NCT06113042
- Acronym / sponsor ID
- KeySteps@JC 2.0
- Conditions
- Lifestyle Modification
- Keywords
- Community child health, Child development, Nutrition, Physical activity, Sleep, Healthy lifestyle, Lifestyle modification, KeySteps
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Nov 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 'KeySteps Phase Two Study' is a 5-year study, which aims to investigate the effectiveness and sustainability of a Community Child Health Model with different services related to healthy lifestyle programmes and health promotion implemented in community settings of deprived living areas. Potential participants are children studying or living in the five selected districts, namely Sham Shui Po, Yuen Long, Tuen Mun, Sha Tin and Kowloon City. Data including children's health and psychosocial conditions, and family demographics will be collected. In addition, subjects will receive on-site assessments on general health and development. Medical and health related events of subjects will be tracked through the existing health care system. Subjects will receive health promotion services and/or lifestyle modification programmes according to their needs.
Detailed description
With the improved economy and rapid growth of socio-economic activities, the socioeconomic gaps between social groups in Hong Kong are widening continuously. According to the Hong Kong Poverty Report of Oxfam Hong Kong (OHK), the richest decile of households made 34.3 times more than the poorest decile prior the COVID pandemic (2019), that number surged to 47.3 times by the first quarter of 2022.1 Similar to the experience in other countries, children from low socio-economic status (SES) families in Hong Kong are at higher risk of physical health, psychological and behavioural problems including obesity/overweight and hypertension, visual, behavioural and learning problems.
Major chronic diseases such as central obesity, hypertension, diabetes mellitus, ischemic heart disease, degenerative retinal and other eye diseases are found to be rooted in childhood related to unhealthy lifestyles, adverse thriving and nutritional environment. The COVID-19 pandemic has exaggerated the existing risks and led to emerging threats among young children, especially in disadvantaged families in Hong Kong in the past two years. With the stringent social isolation, school suspension and home confinement, children's physical health, developmental and behavioral problems have worsened. Experience in a local project, KeySteps@JC funded by HKJC 2017-2022 showed that children in deprived districts were susceptible to nutritional imbalance, physical inactivity and weight problems, especially during the COVID-19 period. Another study also reported the overuse of electronic devices in disadvantaged families. Several other studies also indicated that there were adverse health effects related to COVID-19 pandemic including obesity, deteriorated physical fitness, visual impairment in particular myopia, sleep and emotional disturbance, decreased school readiness, and increased risk of child maltreatment, inattention/hyperactivity and neurodevelopmental disorders, etc.
Lifestyle modification addresses the poor lifestyle choices that are the root causes of chronic diseases. The goal of the lifestyle modification programme is to empower the patient with knowledge, skills, and a desire to create and maintain new habits which are needed to manage their chronic disease and potentially eliminate the root cause. Parental or family involvement in interventions is found to be impactful on lifestyle changes in children, leading to favourable health outcomes. As a result of modelling their parents' behaviour, children are more likely to adopt a healthy lifestyle if their parents demonstrate healthy lifestyle behaviours. Research also found that parents perceived social support to be a key enabler for children to eat healthfully and be active. Group-based health interventions may encourage the building of peer support with additional benefits of social support in the community.
Although lifestyle modification programmes seem promising to address the increasing need of young children, they have not been widely implemented in early childhood public health settings as a main health promotion and disease prevention strategy. This research is to investigate the effectiveness and sustainability of a Community Child Health Model with different services related to healthy lifestyle programmes and health promotion implemented in community settings of deprived living areas.
Potential participants are children studying or living in the five selected districts, namely Sham Shui Po, Yuen Long, Tuen Mun, Sha Tin and Kowloon City. Those districts shared some common disadvantaged backgrounds such as families with lower socio-economic status, mostly living in subdivided units and crowded housing, insufficient public play area and early childhood services. According to the Hong Kong Poverty Situation Report from Census and Statistics Department in 2018, Yuen Long ranked 2nd highest, Tuen Mun 4th, Sham Shui Po 5th, Sha Tin 6th and Kowloon City 9th in terms of 0-6 years old child living in poverty population.11 Moreover, Sham Shui Po was the second-highest district with subdivided units12and Kowloon City ranked third in terms of the number of partitioned flats and second-lowest districts in the public play space area managed by Leisure and Cultural Services Department (LCSD).
This study will be conducted in compliance with the protocol, Declaration of Helsinki and other applicable regulatory requirements.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Comprehensive support (Group 1) | Experimental | Behavioral: Health talks, learning packs, Behavioral: Lifestyle modification programme, Behavioral: School healthy environment evaluationComprehensive health support will be performed both in district community hub and school. Interventional services include heath talks, learning packs, hub-based comprehensive lifestyle modification programme, school healthy environment evaluation. |
| School-based support (Group 2) | Experimental | Behavioral: Health talks, learning packs, Behavioral: Lifestyle modification programme, Behavioral: School healthy environment evaluationInterventional services will be performed in school only, including heath talks, learning packs, school-based lifestyle modification programme, school healthy environment evaluation. |
| District-based support (Group 3) | Experimental | Behavioral: Health talks, learning packs, Behavioral: Lifestyle modification programmeInterventional services will be performed in community hub only, including heath talks, learning packs, hub-based lifestyle modification programme. |
| Control (Group 4) | Placebo comparator | Behavioral: Health talks, learning packsLimited services will be provided including health talks and learning packs. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Children are studying in kindergartens which agree to join the project.
- Parent/legal guardian of the child consented the child's participation in to the study.
- Participants of the Lifestyle modification Programme should be K1 students in academic year 2023/24 of the selected kindergartens and their parents/guardians.
Key exclusion criteria (2 listed)
- Parent/legal guardian of the child cannot understand Cantonese.
- Parent/legal guardian of the child cannot read Chinese.
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 |
|---|---|---|
| Health talks, learning packsAll participants can join the health talks and receive the learning packs. | Behavioural | Comprehensive support (Group 1), Control (Group 4), District-based support (Group 3), School-based support (Group 2) |
| Lifestyle modification programmeIn Group 1: The programme includes both knowledge and activity/practicum sessions for children and parents. It will be carried out in district community hubs. Group 2: The programme focuses on the knowledge sessions for parents. It will be carried out in schools. Group 3: The programme focuses on the activity/practicum sessions for children and parents. It will be carried out in district community hubs. | Behavioural | Comprehensive support (Group 1), District-based support (Group 3), School-based support (Group 2) |
| School healthy environment evaluationEvaluation on school healthy environment will be carried out in Group 1 and Group 2 to enhance the schools to provide a healthy school environment to children. | Behavioural | Comprehensive support (Group 1), School-based support (Group 2) |
Primary outcome
weight
Time frame: 5 years
Assessing children's body weight (kg) to check for overweight or underweight.
Physical activity level
Time frame: 5 years
Assessing the physical activity intensity and duration (minutes) with the activity monitoring device (Actigraph).
Nutritional status
Time frame: 5 years
Assessing the nutritional status and dietary habits with the food frequency questionnaire (electronic version). The frequency and quantity of food intake will be recorded. The consumption of different kinds of nutrients will be calculated and compared with the reference levels to determine the adequacy.
Use of electronic devices
Time frame: 5 years
Assessing the duration of daily use of electronic devices.
Parental awareness
Time frame: 5 years
Assessing changes on parent's knowledge, attitudes and practices on child healthy lifestyle by a questionnaire. A 5-point scale is adopted. The higher the score, the better the result.
1 secondary outcome
Feedback evaluation
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 26 Dec 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.
Amy CHEUNG, BN, MSc contact
Patrick IP, 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?
A study testing Health talks, learning packs, Lifestyle modification programme and School healthy environment evaluation in people with Lifestyle Modification, 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 3 inclusion and 2 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 26 Dec 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. Some participants in this study may receive a placebo. 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, MPH (+852 22554090, patricip@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (time frame: 5 years). The study lists 5 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 26 Dec 2023; AzTrials last refreshed its copy on 27 Oct 2026.