KeySteps@JC Phase Two Study
Effectiveness and Sustainability of a Community Child Health Model in Community Settings
1 other identifier
interventional
6,000
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedFirst Posted
Study publicly available on registry
November 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
December 26, 2023
August 1, 2023
4.2 years
October 3, 2023
December 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
weight
Assessing children's body weight (kg) to check for overweight or underweight.
5 years
Physical activity level
Assessing the physical activity intensity and duration (minutes) with the activity monitoring device (Actigraph).
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.
5 years
Use of electronic devices
Assessing the duration of daily use of electronic devices.
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.
5 years
Secondary Outcomes (1)
Feedback evaluation
5 years
Study Arms (4)
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.
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.
District-based support (Group 3)
EXPERIMENTALInterventional services will be performed in community hub only, including heath talks, learning packs, hub-based lifestyle modification programme.
Control (Group 4)
PLACEBO COMPARATORLimited services will be provided including health talks and learning packs.
Interventions
All participants can join the health talks and receive the learning packs.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Parent/legal guardian of the child cannot understand Cantonese.
- Parent/legal guardian of the child cannot read Chinese.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Hong Kong
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick IP, MPH
The University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2023
First Posted
November 2, 2023
Study Start
November 1, 2023
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
December 26, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share