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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Patrick IP, MPH contact

+852 22554090

patricip@hku.hk

Amy CHEUNG, BN, MSc contact

ahkcheun@hku.hk

Hong Kong1 site, 1 recruiting
  • The University of Hong Kong

    Hong Kong

    Patrick IP, MBBS, MPH, +852 22554090

    Recruiting

Other trials in Hong Kong

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.

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 groups in NCT06113042
Study groupRoleWhat they receive
Comprehensive support (Group 1)ExperimentalComprehensive 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)ExperimentalInterventional 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)ExperimentalInterventional 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 comparatorLimited 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.

  1. weight

    Assessing children's body weight (kg) to check for overweight or underweight.

    Measured: 5 years

  2. Physical activity level

    Assessing the physical activity intensity and duration (minutes) with the activity monitoring device (Actigraph).

    Measured: 5 years

  3. 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

  4. Use of electronic devices

    Assessing the duration of daily use of electronic devices.

    Measured: 5 years

  5. 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)
  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.

  1. First posted2 Nov 2023
  2. Study start1 Nov 2023
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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)
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

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.

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