Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-29 @ 8:32 AM
Study NCT ID:
NCT03918720
Status:
COMPLETED
Last Update Posted:
2024-12-17
First Post:
2017-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Health and Effect of Health Empowerment Programmes Among Families in Tung Chung
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079102', 'term': 'Empowerment'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2017-11-03', 'studyFirstSubmitQcDate': '2019-04-15', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from Baseline Health knowledge test to 60 months', 'timeFrame': 'Up to 1 year', 'description': 'pre and post knowledge test after each health education course.'}, {'measure': 'Overall satisfaction after program', 'timeFrame': 'Up to 1 year', 'description': 'Proportion of participants who reported overall satisfaction with the program.'}], 'primaryOutcomes': [{'measure': 'Change from Patient enablement measured by the Chinese (HK) Patient Enablement Instrument at 60 months', 'timeFrame': 'Up to 60 months', 'description': 'Patient Enablement Instrument-version 2 (PEI-2), score range 5 to 30, higher scores mean better enablement.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline Health Status (global health, mental health) measured by DASS at 60 month', 'timeFrame': 'Up to 60 months', 'description': 'Depression, Anxiety and Stress Scales (DASS), three subscales, each with a score range of 0 to 42, higher scores mean more emotional problems.'}, {'measure': 'Change from Baseline Health-related quality of Life at 60 months', 'timeFrame': 'Up to 60 months', 'description': '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.\n\nChild 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.'}, {'measure': 'Change from Baseline Lifestyle to 60 months', 'timeFrame': 'Up to 60 months', 'description': '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.'}, {'measure': 'Change from Baseline Health parameters to 60 months', 'timeFrame': 'Up to 60 months', 'description': '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.'}, {'measure': 'Change from Baseline Health service utilization pattern to 60 months', 'timeFrame': 'Up to 60 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quality of Life', 'Empowerment', 'Low-income Families', 'Parent-child health relationship'], 'conditions': ['Quality of Life', 'Empowerment']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://doi.org/10.1016/j.jval.2015.09.2872', 'label': 'HRQOL of people from low-income families'}, {'url': 'http://doi.org/10.1136/bmjopen-2015-010015', 'label': 'Protocol'}, {'url': 'http://doi.org/10.15212/FMCH.2016.0124', 'label': 'Correlation of HRQOL between mothers and children'}, {'url': 'http://doi.org/10.1007/s11136-017-1664-8', 'label': 'Effect of intimate partner abuse on behaviour and HRQOL of children'}, {'url': 'http://doi.org/10.1007/s40271-018-0314-8', 'label': 'Maternal chronic disease and HRQOL of children'}, {'url': 'https://doi.org/10.1186/s12889-020-09655-9', 'label': 'Mobile app on parent-child exercises improves physical activity in children'}, {'url': 'https://doi.org/10.1016/j.pec.2024.108240', 'label': 'Health empowerment program improves cardiovascular health'}, {'url': 'https://doi.org/10.1186/s13034-024-00834-9', 'label': 'Health empowerment program improves HRQOL and behaviour in children'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Intervention group (inclusion criteria of Trekkers Families)\n\n 1. Participants included must be part of a family whom all family members are usual residents in Tung Chung;\n 2. The family must have at least one family member working full-time or part-time;\n 3. The family household income does not exceed 75% of monthly median income of Hong Kong;\n 4. At least one child studying Primary 1,2 or 3 at the time of recruitment; and\n 5. At least one adult family member must be willing to participate in the long-term follow up study.\n 6. Only fathers, mothers and children aged 6 or above will be included in this study.\n2. Control group\n\n 1. Participants included must be part of a family whom all family members are usual residents in Hong Kong;\n 2. The family household income does not exceed 75% of monthly median income of Hong Kong;\n 3. At least one child studying Primary 1, 2 or 3 at the time of recruitment;\n 4. Only fathers, mothers and children aged 6 or above will be included in this study.\n\nExclusion Criteria:\n\n1. None of the family member was able to understand or communicate in Chinese language,\n2. The family is receiving Comprehensive Social Security Assistance (CSSA),\n3. Refuse to give consent.'}, 'identificationModule': {'nctId': 'NCT03918720', 'briefTitle': 'The Health and Effect of Health Empowerment Programmes Among Families in Tung Chung', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'In-depth Exploration of a Bidirectional Parent-child Health Relationship and Its Mediating Factors Among Low-income Families in Hong Kong', 'orgStudyIdInfo': {'id': 'UW 12-517'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trekkers', 'interventionNames': ['Behavioral: Trekkers Family Health Empowerment Programme']}, {'type': 'NO_INTERVENTION', 'label': 'Controls'}], 'interventions': [{'name': 'Trekkers Family Health Empowerment Programme', 'type': 'BEHAVIORAL', 'otherNames': ['Trekkers Family'], 'description': 'Health Assessment, Health Enablement and Health Literacy provided to empower participants awareness towards a healthier life style', 'armGroupLabels': ['Trekkers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Cindy Lo Kuen Lam', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Danny D B Ho Professor in Family Medicine and Department Head', 'investigatorFullName': 'Professor Cindy L.K. Lam', 'investigatorAffiliation': 'The University of Hong Kong'}}}}