Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-03-06 @ 1:03 PM
Study NCT ID:
NCT02601534
Status:
COMPLETED
Last Update Posted:
2018-07-12
First Post:
2015-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Be Healthy, So Easy: FAMILY Education Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018476', 'term': 'Hypokinesia'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072001', 'term': 'Diet, Healthy'}], 'ancestors': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 673}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-10', 'studyFirstSubmitDate': '2015-11-05', 'studyFirstSubmitQcDate': '2015-11-08', 'lastUpdatePostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in behavior on performing physical activity in relation to Zero-time Exercise, moderate and vigorous exercises', 'timeFrame': 'baseline, 3 months', 'description': 'Behaviors on performing physical activity will be assessed by outcome-based questionnaire'}], 'secondaryOutcomes': [{'measure': 'Change in behavior on performing physical activity in relation to Zero-time Exercise, moderate and vigorous exercises', 'timeFrame': 'baseline, 3 months, 6 months, 1 year', 'description': 'Behavior on performing physical activity will be assessed by outcome-based and physical activity questionnaire'}, {'measure': 'Change in behavior on taking healthy diet', 'timeFrame': 'baseline, 3 months, 6 months, 1 year', 'description': 'Behavior on taking healthy diet will be assessed by outcome-based healthy diet questionnaire'}, {'measure': 'Attitude on performing Zero-time Exercise,', 'timeFrame': 'immediate after training session, 3 months, 6 months, 1 year', 'description': 'Attitude on performing physical activity in relation to Zero-time Exercise will be assessed by outcome-based questionnaire'}, {'measure': 'Perceived ability and intention to motivate participants themselves and their family to increase Zero-time Exercise', 'timeFrame': 'baseline, 3 months, 6 months, 1 year', 'description': 'Perceived ability and intention to motivate participants themselves and their family members on performing Zero-time Exercise will be assessed by outcome-based questionnaire'}, {'measure': "Change in participants' own health and happiness", 'timeFrame': 'baseline, 3 months, 6 months, 1 year', 'description': 'Personal health and happiness will be assessed by outcome-based questionnaire'}, {'measure': "Change in participants' family harmony", 'timeFrame': 'baseline, 3 months, 6 months, 1 year', 'description': 'Family harmony will be assessed by outcome-based questionnaire'}, {'measure': 'Change in physical fitness performance (Endurance)', 'timeFrame': 'baseline, 3 months,6 months, 1 year', 'description': 'Endurance will be assessed through a simple fitness test called foot pedaling'}, {'measure': "Family members' behavior on performing physical activity in relation to Zero-time Exercise,", 'timeFrame': '6 months', 'description': "Family members' behavior on performing physical activity in relation to Zero-time Exercise will be assessed by outcome-based questionnaire"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sedentary behaviour', 'physical activity'], 'conditions': ['Hypokinesia']}, 'referencesModule': {'references': [{'pmid': '33042934', 'type': 'DERIVED', 'citation': 'Lai AYK, Lam EYW, Fabrizo C, Lee DPK, Wan ANT, Tsang JSY, Ho LM, Stewart SM, Lam TH. A Community-Based Lifestyle-Integrated Physical Activity Intervention to Enhance Physical Activity, Positive Family Communication, and Perceived Health in Deprived Families: A Cluster Randomized Controlled Trial. Front Public Health. 2020 Sep 15;8:434. doi: 10.3389/fpubh.2020.00434. eCollection 2020.'}], 'seeAlsoLinks': [{'url': 'http://www.who.int/en/news-room/fact-sheets/detail/noncommunicable-diseases', 'label': 'World Health Organization (2017). Noncommunicable diseases : Fact Sheet'}, {'url': 'https://www.chp.gov.hk/files/pdf/brfa_report_april_2016_eng.pdf', 'label': 'Department of Health (2016). Behavioural Risk Factor Survey'}]}, 'descriptionModule': {'briefSummary': 'The goal of the study is to evaluate the effectiveness of a family-focused, interactive, and theory-based intervention to reduce the sedentary behavior and increase physical activity, family communication and well-being of the participants.\n\nThe intervention is to use Zero-time Exercise, the positive psychology theme "Appreciation and Gratitude" \\[23, 24\\], and role modelling approach to get sedentary people to start exercising, increase levels of physical activity, family communication and well-being of the participants and their family members.\n\nThe intervention aims to encourage positive and sustainable health actions among participants and their family members.', 'detailedDescription': 'Lack of physical activity is a behavioural risk for non-communicable diseases. The World Health Organization (WHO) reported that physical inactivity and unhealthy diets are two of the four main behavioural risk factors that contribute to non-communicable diseases. Globally, people who are overweight and obese, particularly if these people are physically inactive. They are at risk for morbidity and mortality.\n\nHong Kong-specific data demonstrates that many people cannot meet World Health Organization targets for physical activity. The Hong Kong Behavioural Risk Factor Survey reported that, for the seven days prior to the survey, about half (52.0%) of adults aged 18-64 had not done any moderate physical activity. Overall, only 37.5% of the respondents met the WHO\'s recommended physical activity level of at least 150 minutes of moderate or 75 minutes of vigorous physical activity a week for adults.\n\nThere is emerging evidence of effective behavioral interventions to decrease sedentary behavior. Some studies focused on reducing screen time or active workstations that encourage standing at the computer. Others focus on increased use of stairs instead of lifts. These interventions used behaviour change techniques such as goal-setting and behavioural self-monitoring. As previous approaches have not shown promising results, new approaches are needed to reduce sedentary behaviour and increase exercise or physical activity.\n\nThe goal of the study is to evaluate the effectiveness of a family-focused, interactive, and theory-based intervention to reduce the sedentary behavior and increase physical activity of the participants.\n\nThe intervention is to use Zero-time Exercise, the positive psychology theme "Appreciation and Gratitude", and role modelling approach to get sedentary people to start exercising, increase levels of physical activity, family communication and well-being of the participants and their family members. The intervention aims to encourage positive and sustainable health actions among participants and their family members.\n\nNeeds assessment and focus group interview will be conducted before program design and after conducting the training, respectively. Process evaluation will be performed to evaluate the process of each component of the program. Qualitative and quantitative assessments will be used to evaluate the effectiveness of this Zero-time Exercise intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Parents with at least on child between 3 and 18;\n2. Parents with at least primary school educational level:\n3. Parents who can read and write Chinese.\n\nExclusion Criteria:\n\n1. People with a serious health condition that might prevent them from participating in physical activity;\n2. Parents who do not have a child between 3 and 18.'}, 'identificationModule': {'nctId': 'NCT02601534', 'briefTitle': 'Be Healthy, So Easy: FAMILY Education Project', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Be Healthy, So Easy: FAMILY Education Project', 'orgStudyIdInfo': {'id': 'UW 15-330'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zero-time Exercise (PA) group', 'description': 'The intervention arm (PA group) aims to improve family communication and well-being, reduce sedentary behavior and increase physical activity. The programme includes a knowledge and motivation enhancement session at baseline, an experience sharing session at 3 months, a family gathering session at 6 months, and a holistic health session at 12 months after the first session as well as biweekly/monthly mobile messages.\n\nThe holistic health session is not a part of the cRCT, it aims to collect one-year feedback from participants and provides additional health information to improve dietary habits.', 'interventionNames': ['Behavioral: Zero-time Exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Healthy Eating (HE) group', 'description': 'The control arm (HE group) aims to improve family communication and well-being and enhance healthy eating habits. Participants are required to engage their family members in their activities. The programme includes a knowledge and motivation enhancement session at baseline, an experience sharing session at 3 months, a family gathering session at 6 months, and a holistic health session at 12 months after the first session as well as biweekly/monthly mobile messages.\n\nThe holistic health session is not a part of the cRCT, it aims to collect one-year feedback from participants and provides additional health information to improve physical activity habit.', 'interventionNames': ['Behavioral: Healthy Eating']}], 'interventions': [{'name': 'Zero-time Exercise', 'type': 'BEHAVIORAL', 'description': 'a knowledge and motivation enhancement session at baseline, an experience sharing session at 3 months, a family gathering session at 6 months, and a holistic health session at 12 months (not a part of cRCT, for the collection of feedback only) as well as biweekly/monthly mobile messages to improve physical activity habit.', 'armGroupLabels': ['Zero-time Exercise (PA) group']}, {'name': 'Healthy Eating', 'type': 'BEHAVIORAL', 'description': 'a knowledge and motivation enhancement session at baseline, an experience sharing session at 3 months, a family gathering session at 6 months, and a holistic health session at 12 months (not a part of cRCT, for the collection of feedback only) as well as biweekly/monthly mobile messages to improve dietary habit.', 'armGroupLabels': ['Healthy Eating (HE) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '852', 'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Caritas integrated Family Service Centre', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Agnes YK Lai, DN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Caritas Medical Centre, Hong Kong', 'class': 'OTHER'}, {'name': 'The Hong Kong Jockey Club Charities Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Project Manager (Health Communication)', 'investigatorFullName': 'Dr. Agnes Yuen-Kwan Lai', 'investigatorAffiliation': 'The University of Hong Kong'}}}}