Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-20 @ 10:13 PM
Study NCT ID:
NCT03146169
Status:
COMPLETED
Last Update Posted:
2018-05-14
First Post:
2017-05-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Training Program for Community Health Campaign: Fitter Families Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012681', 'term': 'Sensitivity Training Groups'}], 'ancestors': [{'id': 'D011615', 'term': 'Psychotherapy, Group'}, {'id': 'D012960', 'term': 'Socioenvironmental Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A four-session training workshop is provided to the trainees in order to enhance their competence and performance for conducing and/or assisting the implementation of community -based interventions and activities.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-07', 'studyFirstSubmitDate': '2017-05-05', 'studyFirstSubmitQcDate': '2017-05-08', 'lastUpdatePostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in trainees' learning", 'timeFrame': 'baseline, immediately after first session "up to 30 min", one month and three months', 'description': 'Assessed by outcome-based questionnaire'}], 'secondaryOutcomes': [{'measure': "Trainees' reactions to training content", 'timeFrame': 'Immediately after the training workshop', 'description': 'Assessed by outcome-based questionnaire'}, {'measure': "Trainees' changes in the frequency and amount on performing physical exercise adn Zero Time Exercise", 'timeFrame': 'baseline, one month and three months', 'description': 'Assessed by outcome-based questionnaire on performing moderate exercise, vigorous exercise and Zero Time Exercise and walking'}, {'measure': "Trainees' changes in grip strength (kg)", 'timeFrame': 'baseline and one month', 'description': 'assessed by a hand grip dynamometer'}, {'measure': "Trainees' changes in chair stand (times)", 'timeFrame': 'Assessed 30s Chair stand test ( a test counting number of times from sitting position to standing position in 30 seconds', 'description': 'baseline and one month'}, {'measure': "Trainees' changes in single-leg standing time (second)", 'timeFrame': 'Assessed by a single-leg stance test ( a test measuring the longest duration of a single leg in 120 seconds)', 'description': 'baseline and one month'}, {'measure': "Trainees' changes in seat and reach (cm)", 'timeFrame': 'Baseline and one month', 'description': 'Assessed by a ruler'}, {'measure': "Trainees' changes in body fat (%)", 'timeFrame': 'Baseline and one month', 'description': 'Assessed by a standard body fat and weight measuring scale'}, {'measure': "Trainees' changes in body weight (kg)", 'timeFrame': 'Baseline and one month', 'description': 'Assessed by a standard body fat and weight measuring scale'}, {'measure': "Trainees' changes in frequency and amount on performing physical activity and Zero Time Exercise)", 'timeFrame': 'baseline, one month and three months', 'description': 'Assessed by outcome-based questionnaire on performing moderate exercise, vigorous exercise and Zero Time Exercise and walking'}, {'measure': "Trainees' changes in personal happiness", 'timeFrame': 'baseline, one month and three months', 'description': 'Assessed by outcome-based questionnaire'}, {'measure': "Trainees' changes in personal health", 'timeFrame': 'baseline, one month and three months', 'description': 'Assessed by outcome-based questionnaire'}, {'measure': "Trainees' changes in family health", 'timeFrame': 'baseline, one month and three months', 'description': 'Assessed by outcome-based questionnaire'}, {'measure': "Trainees' changes in family happiness", 'timeFrame': 'baseline, one month and three months', 'description': 'Assessed by outcome-based questionnaire'}, {'measure': "Trainees' changes in family harmony", 'timeFrame': 'baseline, one month and three months', 'description': 'Assessed by outcome-based questionnaire'}, {'measure': "Trainees' changes in sharing health knowledge with family members in relation to physical activity", 'timeFrame': 'baseline, one month and three months', 'description': 'Assessed by outcome-based questionnaire'}, {'measure': "Trainees' changes in doing physical activity and exercise with family", 'timeFrame': 'baseline, one month and three months', 'description': 'Assessed by outcome-based questionnaire'}, {'measure': "Trainees' comments on the received electronic health messages", 'timeFrame': 'baseline, one month and three months', 'description': 'Assessed by outcome-based questionnaire'}, {'measure': "Community participants' changes in family health", 'timeFrame': 'baseline, one month and three months', 'description': 'Assessed by outcome-based questionnaire'}, {'measure': "Community participants' changes in family happiness", 'timeFrame': 'baseline, one month and three months', 'description': 'Assessed by outcome-based questionnaire'}, {'measure': "Community participants' changes in family harmony", 'timeFrame': 'baseline, one month and three months', 'description': 'Assessed by outcome-based questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Motor Activity']}, 'referencesModule': {'references': [{'pmid': '19139157', 'type': 'BACKGROUND', 'citation': 'Wacharasin C, Theinpichet S. Family nursing practice, education, and research: what is happening in Thailand? J Fam Nurs. 2008 Nov;14(4):429-35. doi: 10.1177/1074840708327515.'}, {'pmid': '12699277', 'type': 'BACKGROUND', 'citation': 'Denham SA. Family routines: a structural perspective for viewing family health. ANS Adv Nurs Sci. 2002 Jun;24(4):60-74. doi: 10.1097/00012272-200206000-00010.'}, {'pmid': '22751883', 'type': 'BACKGROUND', 'citation': 'Yoshikawa H. Integrating methods in the science of family health: new directions from an institute of medicine workshop report. Arch Pediatr Adolesc Med. 2012 Jul 1;166(7):659-61. doi: 10.1001/archpediatrics.2012.510. No abstract available.'}, {'pmid': '1541473', 'type': 'BACKGROUND', 'citation': 'Anderson KH, Tomlinson PS. The family health system as an emerging paradigmatic view for nursing. Image J Nurs Sch. 1992 Spring;24(1):57-63. doi: 10.1111/j.1547-5069.1992.tb00700.x.'}, {'pmid': '29961808', 'type': 'DERIVED', 'citation': 'Lai AYK, Stewart SM, Wan ANT, Shen C, Ng CKK, Kwok LT, Chan SS, Ho DSY, Lam TH. Training to implement a community program has positive effects on health promoters: JC FAMILY Project. Transl Behav Med. 2018 Nov 21;8(6):838-850. doi: 10.1093/tbm/iby070.'}]}, 'descriptionModule': {'briefSummary': 'In recent years, Hong Kong has been undergoing rapid changes with macro social and economic trends. The increasingly complex and diverse family structure contribute to concerns regarding the well-being of families in Hong Kong, including their health, happiness and harmony (FAMILY 3Hs). Family life and health education should be strengthened to meet the increasing needs of promoting healthy active lifestyle among Hong Kong families. In this connection, the FAMILY Project initiates the Fitter Families Project (FFP) with a focus on "FAMILY Holistic Health", will be conducted in order to increase the awareness of the importance of FAMILY 3Hs. FFP is a community-based research project with 3 main components - train-the-trainer program, community-based family interventions and public education events. It is expected that trainees from the train-the-trainer program will acquire adequate skills to organize community-based health education programs effectively. Participants of the community-based family interventions will gain knowledge on family holistic health and live a healthy active lifestyle. Attendees of the public education events will become more aware of the importance of FAMILY 3Hs.', 'detailedDescription': 'In 2011, United Nations (UN) addressed the prevention and control of four non-communicable diseases (NCDs: cancer, cardiovascular disease, chronic respiratory disease, and diabetes mellitus) worldwide. The UN, in its Political Declaration, recognized the critical importance of reducing the exposure to the common modifiable risk factors for NCDs, namely, tobacco use, unhealthy diet, physical inactivity, and the harmful use of alcohol.In Hong Kong, NCDs are responsible for more than 85% of all deaths and most of these are preventable. FAMILY Project Cohort Study (2014) also found that 88.6% of Hong Kong people had inadequate vegetable and fruit intake, 70.6% had inadequate physical exercise, 26.4% were overweight and 5.4% were obese.\n\nFamilies worldwide have been undergoing rapid changes with macro, social and economic trends. Demographic shifts, economic upheavals, changing societal norms and values, immigration across national borders and migration within nations are creating new and altered structures, processes and relationships within families. The increasingly complex and diverse family structure contributes to concerns regarding the well-being of families in Hong Kong, including their health, happiness and harmony (FAMILY 3Hs). Family life and health education should be strengthened to meet the increasing needs of promoting healthy lifestyle among Hong Kong families.\n\nThe Fitter Families Project is developed based on the strong foundation of the Learning Families Project in the previous years. In view of the health challenges locally and globally, the new phase of FAMILY project will put more emphasis on health in the upcoming three years. Following the themes on FAMILY health, happiness and harmony (3Hs), the Fitter Families Project focuses on family holistic health with emphasis on the interaction and integration of both physical and psychosocial health.\n\nAs an initial step of this project, the investigators conducted a need assessments before designing and conducting a train-the-trainer program. The train-the-trainer program aimed to prepare the staff and lay volunteers to conduct and or assist to implement a series of community-based activities and interventions for the participants of Fitter Families Project. Focus group interviews were conducted to obtain feedback and opinion from the trainees . Questionnaire assessments were conducted before, immediately after finishing the training, three months after training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chinese speaking\n* able to complete assessments\n\nExclusion Criteria:\n\n* not fit the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT03146169', 'briefTitle': 'Training Program for Community Health Campaign: Fitter Families Project', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Training Program for Community Health Campaign: Fitter Families Project', 'orgStudyIdInfo': {'id': 'UW15 - 401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training group', 'description': 'Four two-hour training sessions were conducted at baseline, and one week, one month and three months after the first session.', 'interventionNames': ['Behavioral: Training group']}], 'interventions': [{'name': 'Training group', 'type': 'BEHAVIORAL', 'description': 'The training workshop includes four two-hour sessions:\n\nSession one - a knowledge, self-efficacy, and motivation enhancement session at baseline; Session two - an interpersonal communication and leadership skills session at one week; Session three - a motivation enhancement session at one month Session four - an experience sharing session at three months', 'armGroupLabels': ['Training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '852', 'city': 'Kwun Tong', 'country': 'Hong Kong', 'facility': 'Christian Family Service Centre', 'geoPoint': {'lat': 22.31184, 'lon': 114.22176}}], 'overallOfficials': [{'name': 'Agnes YK Lai, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The minimal anonymized dataset will be available upon request to interested researchers. For interested researchers, please contact, Ms Grace Lau (email gclau@hku.hk), (School of Public Health, The University of Hong Kong) for further information."'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Officer', 'investigatorFullName': 'Dr. Agnes Yuen-Kwan Lai', 'investigatorAffiliation': 'The University of Hong Kong'}}}}