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Quality of LifeNCT03918720

The Health and Effect of Health Empowerment Programmes Among Families in Tung Chung

A study testing Trekkers Family Health Empowerment Programme in people with Quality of Life and Empowerment, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 6 years and olderHealthy volunteers can take part
Conditions the study is for
Quality of Life, Empowerment
What is being tested?
Trekkers Family Health Empowerment Programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
1 siteHong Kong
Study dates
1 Feb 2013to 30 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

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 6 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Intervention group (inclusion criteria of Trekkers Families)
  • Participants included must be part of a family whom all family members are usual residents in Tung Chung;
  • The family must have at least one family member working full-time or part-time;
  • The family household income does not exceed 75% of monthly median income of Hong Kong;
  • At least one child studying Primary 1,2 or 3 at the time of recruitment; and
  • At least one adult family member must be willing to participate in the long-term follow up study.
Show all 12Show fewer
  • Only fathers, mothers and children aged 6 or above will be included in this study.
  • Control group
  • Participants included must be part of a family whom all family members are usual residents in Hong Kong;
  • The family household income does not exceed 75% of monthly median income of Hong Kong;
  • At least one child studying Primary 1, 2 or 3 at the time of recruitment;
  • Only fathers, mothers and children aged 6 or above will be included in this study.

Who cannot join

  • None of the family member was able to understand or communicate in Chinese language,
  • The family is receiving Comprehensive Social Security Assistance (CSSA),
  • Refuse to give consent.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: In-depth Exploration of a Bidirectional Parent-child Health Relationship and Its Mediating Factors Among Low-income Families in Hong Kong

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.

Read the detailed 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.

Being tested
Trekkers Family Health Empowerment Programme
Keywords
Quality of Life, Empowerment, Low-income Families, Parent-child health relationship
Medical subject headings
Empowerment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trekkers Family Health Empowerment ProgrammeBehavioural

    Also called Trekkers Family

    Health Assessment, Health Enablement and Health Literacy provided to empower participants awareness towards a healthier life style

Study groups in NCT03918720
Study groupRoleWhat they receive
TrekkersExperimentalNot described
Receives: Behavioral: Trekkers Family Health Empowerment Programme
ControlsNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Patient enablement measured by the Chinese (HK) Patient Enablement Instrument at 60 months

    Patient Enablement Instrument-version 2 (PEI-2), score range 5 to 30, higher scores mean better enablement.

    Measured: Up to 60 months

Secondary outcomes (5)

  1. Change from Baseline Health Status (global health, mental health) measured by DASS at 60 month

    Depression, Anxiety and Stress Scales (DASS), three subscales, each with a score range of 0 to 42, higher scores mean more emotional problems.

    Measured: Up to 60 months

  2. Change from Baseline Health-related quality of Life at 60 months

    12-item Short Form Health Survey-version 2 (SF-12v2) in adults: Physical Component Summary and Mental Component Summary scores, norm-based with a population mean of 50 and SD of 10, higher score means better quality of life.

    Child Health Questionnaire-Parent Form-28 items: Total Difficulty summary score ranges from 0-40, higher scores mean more behavioral difficulties; a prosocial scale score ranges from 0 to 10, higher scores mean better behavior.

    Measured: Up to 60 months

  3. Change from Baseline Lifestyle to 60 months

    proportion of participants with unhealthy lifestyle including smoking, <150min/wk of exercises, consumption of surgery drinks, smoking cigarettes, consumption of less than 5 portions of fruits and vegetables.

    Measured: Up to 60 months

  4. Change from Baseline Health parameters to 60 months

    Cardiovascular Health Index (CVHI) measured by optimal blood pressure, body mass index, blood cholesterol, blood glucose, smoking status, physical activity, and fruit and vegetable intake, score ranges from 0 to 7, higher scores mean better CVH.

    Measured: Up to 60 months

  5. Change from Baseline Health service utilization pattern to 60 months

    Proportion of people who reported to Have a family doctor, self-care for an illness, use of Accident and Emergency service during an illness episode.

    Measured: Up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2019
  2. Study start1 Feb 2013
  3. Primary completion31 Dec 2022
  4. Study completion30 Jun 2023

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03918720
Sponsor's protocol ID
UW 12-517
Status last verified
Dec 2024
First submitted
3 Nov 2017
Last updated
17 Dec 2024
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 Trekkers Family Health Empowerment Programme in people with Quality of Life and Empowerment, 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 12 inclusion and 3 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: finished, as of the sponsor's last update on 17 Dec 2024. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Patient enablement measured by the Chinese (HK) Patient Enablement Instrument at 60 months (time frame: Up to 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03918720.

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 17 Dec 2024.

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