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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03918720
Other study ID # UW 12-517
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2013
Est. completion date June 30, 2023

Study information

Verified date December 2023
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Kerry Group Kuok Foundation Limited (KGKF) has initiated the Trekkers Family Project that aims to enable low-income families to develop their full potentials by providing support and opportunities in education, employment, environmental harmony and health. Health is an essential component to enable a person to develop his/her full potential. This study looks into one of the key elements, health, of members of low-income families and the effect of health education, health enablement and mutual health support on health and social outcomes. It is a cohort study of around 800 subjects from 200 families of the Trekkers Family Project, and around 800 subjects not included in the Trekkers Family Project in Hong Kong, recruited base on pre-defined inclusion criteria. Health empowerment interventions consisting of three inter-related programmes, namely, the Health Literacy, the Self-care Enablement, and the Health Ambassador Programmes.


Description:

The Health Literacy Programme aims to improve the knowledge on health and health services in order to promote health, prevent disease, and the proper use of services. It consists of four seminars per year on common health problems, mental health and cognitive health, etc. The Self-Care Enablement Programme is to enable participants to keep themselves healthy, to build up self-efficacy and proper help-seeking skills, and to generate a spirit of mutual support among families. Two programmes will be delivered yearly, each with six 2.5 hour workshops facilitated by professional and lay leaders. The Health Ambassador Programme aims to train up a group of adults recruited from the Trekkers families to act as a lay-advisor to other families on health issues. Participants who have completed the Health Literacy and Self-care Enablement programme will be given priority to take part in the Health Ambassador training programme. The outcome measures are health enablement, health status, health-related quality of life, life style, cardiovascular risk factors, illnesses rates, and health service utilization pattern. All subjects in the cohort study will be surveyed on enrolment, and then yearly for 5 years. An age-gender appropriate health assessment will be carried out at baseline and at the end of five years for each subject. Changes in the outcomes will be evaluated and compared between groups. The impact of the health intervention programmes will be assessed.


Recruitment information / eligibility

Status Completed
Enrollment 1200
Est. completion date June 30, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years and older
Eligibility Inclusion Criteria: 1. Intervention group (inclusion criteria of Trekkers Families) 1. Participants included must be part of a family whom all family members are usual residents in Tung Chung; 2. The family must have at least one family member working full-time or part-time; 3. The family household income does not exceed 75% of monthly median income of Hong Kong; 4. At least one child studying Primary 1,2 or 3 at the time of recruitment; and 5. At least one adult family member must be willing to participate in the long-term follow up study. 6. Only fathers, mothers and children aged 6 or above will be included in this study. 2. Control group 1. Participants included must be part of a family whom all family members are usual residents in Hong Kong; 2. The family household income does not exceed 75% of monthly median income of Hong Kong; 3. At least one child studying Primary 1, 2 or 3 at the time of recruitment; 4. Only fathers, mothers and children aged 6 or above will be included in this study. Exclusion Criteria: 1. None of the family member was able to understand or communicate in Chinese language, 2. The family is receiving Comprehensive Social Security Assistance (CSSA), 3. Refuse to give consent.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Trekkers Family Health Empowerment Programme
Health Assessment, Health Enablement and Health Literacy provided to empower participants awareness towards a healthier life style

Locations

Country Name City State
Hong Kong The University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Other Change from Baseline Health knowledge test to 60 months Up to 1 year
Other Change from Baseline Health enablement by the Patient Enablement Instrument and overall satisfaction to 60 months Up to 1 year
Other Change from Baseline Self-management, self-efficacy by the Self Efficacy Scale and Readiness to change by the Readiness to Change Scale to 60 months Up to 1 year
Primary Change from Patient enablement measured by the Chinese (HK) Patient Enablement Instrument at 60 months Up to 60 months
Secondary Change from Baseline Health Status (global health, mental health) measured by DASS at 60 month Up to 60 months
Secondary Change from Baseline Health-related quality of Life measured by the Chinese (HK) SF-12v2 Health Survey at 60 months Up to 60 months
Secondary Change from Baseline Lifestyle to 60 months Number of participants with unhealthy lifestyle Up to 60 months
Secondary Change from Baseline Health parameters to 60 months Including blood pressure, body mass index; lipids and blood glucose, for adults only; vitamin D, iron, mercury and lead Up to 60 months
Secondary Change from Baseline Health service utilization pattern to 60 months Having a family doctor, self-care, use of Accident and Emergency service Up to 60 months
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