Health TrialsbyHealthPanel

KeySteps@JC Phase Two Study

ConditionLifestyle Modification
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3+
SponsorThe University of Hong Kong

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Parent/legal guardian of the child cannot understand Cantonese.

Parent/legal guardian of the child cannot read Chinese.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Health talks, learning packs

    Behavioral

    All participants can join the health talks and receive the learning packs.

  • Lifestyle modification programme

    Behavioral

    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 evaluation

    Behavioral

    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.

Treatment groups

6,000 Participants
are divided into 4 treatment groups
Group A: Comprehensive support (Group 1)Experimental treatment 3 interventions
Group B: School-based support (Group 2)Experimental treatment 3 interventions
Group C: District-based support (Group 3)Experimental treatment 2 interventions
Group D: Control (Group 4)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

weight

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

Time frame
5 years
2

Physical activity level

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

Time frame
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.

Time frame
5 years
4

Use of electronic devices

Assessing the duration of daily use of electronic devices.

Time frame
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.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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