- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03918720
The Health and Effect of Health Empowerment Programmes Among Families in Tung Chung
In-depth Exploration of a Bidirectional Parent-child Health Relationship and Its Mediating Factors Among Low-income Families in Hong Kong
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- The University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Trekkers
|
Health Assessment, Health Enablement and Health Literacy provided to empower participants awareness towards a healthier life style
Other Names:
|
|
No Intervention: Controls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Patient enablement measured by the Chinese (HK) Patient Enablement Instrument at 60 months
Time Frame: Up to 60 months
|
Patient Enablement Instrument-version 2 (PEI-2), score range 5 to 30, higher scores mean better enablement.
|
Up to 60 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline Health Status (global health, mental health) measured by DASS at 60 month
Time Frame: Up to 60 months
|
Depression, Anxiety and Stress Scales (DASS), three subscales, each with a score range of 0 to 42, higher scores mean more emotional problems.
|
Up to 60 months
|
|
Change from Baseline Health-related quality of Life at 60 months
Time Frame: Up to 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. |
Up to 60 months
|
|
Change from Baseline Lifestyle to 60 months
Time Frame: Up 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.
|
Up to 60 months
|
|
Change from Baseline Health parameters to 60 months
Time Frame: Up 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.
|
Up to 60 months
|
|
Change from Baseline Health service utilization pattern to 60 months
Time Frame: Up 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.
|
Up to 60 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline Health knowledge test to 60 months
Time Frame: Up to 1 year
|
pre and post knowledge test after each health education course.
|
Up to 1 year
|
|
Overall satisfaction after program
Time Frame: Up to 1 year
|
Proportion of participants who reported overall satisfaction with the program.
|
Up to 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cindy Lo Kuen Lam, The University of Hong Kong
Publications and helpful links
Helpful Links
- HRQOL of people from low-income families
- Protocol
- Correlation of HRQOL between mothers and children
- Effect of intimate partner abuse on behaviour and HRQOL of children
- Maternal chronic disease and HRQOL of children
- Mobile app on parent-child exercises improves physical activity in children
- Health empowerment program improves cardiovascular health
- Health empowerment program improves HRQOL and behaviour in children
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UW 12-517
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
Ziekenhuis Oost-LimburgRecruitingQuality of Life | Postoperative Quality of Recovery | Health-Related Quality-of-LifeBelgium
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
Istituto Ortopedico RizzoliUniversity of BolognaCompletedImprove Quality of LifeItaly
-
Children's National Research InstituteCompletedProfessional Quality of LifeUnited States
-
Region VästmanlandUnknownHealth Related Quality of Life
-
Ain Shams UniversityCompletedHealth Related Quality of LifeEgypt
-
Institute of Oncology LjubljanaUnknownHealth-related Quality of LifeSlovenia
-
Oslo University HospitalNorwegian Fund for Postgraduate Training in PhysiotherapyCompletedHealth-Related Quality of LifeNorway
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
Clinical Trials on Trekkers Family Health Empowerment Programme
-
Elif Güzide EmirzaGazi UniversityNot yet recruitingViolence, Domestic | Battered Women | Mindfulness
-
University of ChicagoNational Institute of Mental Health (NIMH)RecruitingChild Behavior Problem | Mental Health | Child Externalizing ProblemsAzerbaijan
-
Shahid Beheshti University of Medical SciencesCompletedCystic Fibrosis in ChildrenIran, Islamic Republic of
-
Baqiyatallah Medical Sciences UniversityTarbiat Modarres UniversityCompletedAcute Myocardial Infarction: Rehabilitation Phase
-
Xiaowan LiNot yet recruiting
-
Tzu Chi UniversityCompletedDementia Family CaregiverTaiwan
-
Baqiyatallah Medical Sciences UniversityShahid Beheshti University; Tehran University of Medical SciencesCompletedAcute Respiratory Distress Syndrome | Tobacco; Use, Rehabilitation
-
The University of Hong KongCompleted
-
University of ChicagoEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsActive, not recruitingChild Mental Disorder | Child Maltreatment | Emotional TraumaAzerbaijan
-
Stanford UniversityCalifornia Department of Developmental ServicesActive, not recruitingAutism Spectrum Disorder | Autistic Disorder | Autism | Autism Spectrum Disorders | Autistic Disorders Spectrum | Autistic Spectrum Disorder | Autistic Spectrum DisordersUnited States