Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-03-06 @ 12:04 AM
Study NCT ID:
NCT04463069
Status:
COMPLETED
Last Update Posted:
2022-05-09
First Post:
2020-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
School-based Physical Activity Intervention for Obesity Among Adolescents With Intellectual Disability in Hong Kong
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gaoyang@hkbu.edu.hk', 'phone': '+852 3411 3082', 'title': 'Dr. Yang Gao', 'organization': 'Hong Kong Baptist University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '9 months', 'description': 'Possible adverse effects (e.g., sports injury, underweight, binge eating) suggested by previous studies will be prevented via diverse means (e.g., to inform children and parents of the possible adverse consequences in advance and provide feasible and practical preventive strategies to them). They can reach the research team via a hotline on an ad hoc basis. The adverse events will be monitored among participants who completed the baseline assessments.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Group', 'description': 'Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.\n\nAdapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Participants in the control group received no intervention in the study time period.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'BMI Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.\n\nAdapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in the control group received no intervention in the study time period.'}], 'classes': [{'title': 'Mean change from baseline to 4 months', 'categories': [{'measurements': [{'value': '-0.14', 'groupId': 'OG000', 'lowerLimit': '-0.44', 'upperLimit': '0.16'}, {'value': '0.42', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.73'}]}]}, {'title': 'Mean change from baseline to 9 months', 'categories': [{'measurements': [{'value': '-0.66', 'groupId': 'OG000', 'lowerLimit': '-1.06', 'upperLimit': '-0.25'}, {'value': '0.68', 'groupId': 'OG001', 'lowerLimit': '0.16', 'upperLimit': '1.20'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at 4 months and 9 months', 'description': 'The primary outcome variable was change in BMI (weight (kg) / height2 (m)) that was further calculated from the height and weight measured at school in the morning time. Height was measured to the nearest 0.1 cm using a stadiometer and weight was measured to the nearest 0.1 kg on a TANITA digital scale (TBF-410) with the subject wearing lightweight clothing and no shoes.', 'unitOfMeasure': 'kg/m2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'BMIz Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.\n\nAdapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in the control group received no intervention in the study time period.'}], 'classes': [{'title': 'Mean change from baseline to 4', 'categories': [{'measurements': [{'value': '-0.06', 'groupId': 'OG000', 'lowerLimit': '-0.12', 'upperLimit': '-0.00'}, {'value': '0.07', 'groupId': 'OG001', 'lowerLimit': '-0.00', 'upperLimit': '0.14'}]}]}, {'title': 'Mean change from baseline to 9', 'categories': [{'measurements': [{'value': '-0.23', 'groupId': 'OG000', 'lowerLimit': '-0.32', 'upperLimit': '-0.14'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '-0.03', 'upperLimit': '0.22'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at 4 months and 9 months', 'description': 'The BMIz was converted from the BMI values using WHO 2007 reference standards. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values denote a higher BMI.', 'unitOfMeasure': 'z-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Weight Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.\n\nAdapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in the control group received no intervention in the study time period.'}], 'classes': [{'title': 'Mean change from baseline to 4', 'categories': [{'measurements': [{'value': '0.42', 'groupId': 'OG000', 'lowerLimit': '-0.28', 'upperLimit': '1.12'}, {'value': '1.79', 'groupId': 'OG001', 'lowerLimit': '0.90', 'upperLimit': '2.68'}]}]}, {'title': 'Mean change from baseline to 9', 'categories': [{'measurements': [{'value': '-0.15', 'groupId': 'OG000', 'lowerLimit': '-1.06', 'upperLimit': '0.75'}, {'value': '2.76', 'groupId': 'OG001', 'lowerLimit': '1.45', 'upperLimit': '4.07'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at 4 months and 9 months', 'description': 'Weight was measured to the nearest 0.1 kg on a calibrated TANITA digital scale (TBF-410) with the subject wearing lightweight clothing and no shoes.', 'unitOfMeasure': 'kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Body Fat Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.\n\nAdapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in the control group received no intervention in the study time period.'}], 'classes': [{'title': 'Mean change from baseline to 4', 'categories': [{'measurements': [{'value': '-0.19', 'groupId': 'OG000', 'lowerLimit': '-1.18', 'upperLimit': '0.80'}, {'value': '0.80', 'groupId': 'OG001', 'lowerLimit': '-0.24', 'upperLimit': '1.84'}]}]}, {'title': 'Mean change from baseline to 9', 'categories': [{'measurements': [{'value': '-1.46', 'groupId': 'OG000', 'lowerLimit': '-2.41', 'upperLimit': '-0.52'}, {'value': '0.24', 'groupId': 'OG001', 'lowerLimit': '-0.60', 'upperLimit': '1.07'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at 4 months and 9 months', 'description': 'Percent body fat was measured with the TANITA digital scale (TBF-410) using foot-to-foot bioelectrical impedance analysis.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Waist Circumference Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.\n\nAdapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in the control group received no intervention in the study time period.'}], 'classes': [{'title': 'Mean change from baseline to 4', 'categories': [{'measurements': [{'value': '-1.66', 'groupId': 'OG000', 'lowerLimit': '-3.02', 'upperLimit': '-0.29'}, {'value': '1.50', 'groupId': 'OG001', 'lowerLimit': '-0.01', 'upperLimit': '3.01'}]}]}, {'title': 'Mean change from baseline to 9', 'categories': [{'measurements': [{'value': '-2.02', 'groupId': 'OG000', 'lowerLimit': '-3.80', 'upperLimit': '-0.23'}, {'value': '1.76', 'groupId': 'OG001', 'lowerLimit': '-0.25', 'upperLimit': '3.77'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at 4 months and 9 months', 'description': 'Waist circumference (cm) was measured with a flexible meter ribbon accurate to 0.1 cm at the midway between the lowest rib margin and the top of the iliac crest at the end of gentle expiration', 'unitOfMeasure': 'cm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Waist-to-height Ratio Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.\n\nAdapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in the control group received no intervention in the study time period.'}], 'classes': [{'title': 'Mean change from baseline to 4', 'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000', 'lowerLimit': '-0.02', 'upperLimit': '-0.00'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '-0.00', 'upperLimit': '0.02'}]}]}, {'title': 'Mean change from baseline to 9', 'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000', 'lowerLimit': '-0.03', 'upperLimit': '-0.01'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '-0.01', 'upperLimit': '0.02'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at 4 months and 9 months', 'description': 'Waist-to-height ratio was calculated by dividing the waist circumference by the height.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cardiorespiratory Fitness Change', 'timeFrame': 'Change from baseline at 4 months and 9 months', 'description': 'Cardiorespiratory fitness was assessed using the 9-minute run/walk test. The test measured how far a person can cover a flat surface 25 meters in length over a 9-minute period.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Muscular Strength and Endurance Change', 'timeFrame': 'Change from baseline at 4 months and 9 months', 'description': 'The muscular strength and endurance were measured by handgrip strength and sit-ups. The handgrip strength was measured using a dynamometer (Takei, TKK5001, GRIP-A digital dynamometer). The sit-ups measured the total number of correctly completed sit-ups performed in 30 seconds.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Flexibility Change', 'timeFrame': 'Change from baseline at 4 months and 9 months', 'description': 'Flexibility was measured by the sit-and-reach test.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Group', 'description': 'Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.\n\nAdapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Participants in the control group received no intervention in the study time period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': "Participants' parents refused to participate after learning the assignment results", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}], 'recruitmentDetails': 'Initially, 81 eligible students with parental informed consent were recruited (41 in intervention and 40 in control). 13 in control withdrew after learning the assignment results. 5 more were then recruited into the control to fulfill sample size (32). After commencement of study, 2 and 10 withdrew from intervention and control respectively. Finally, 61 (39 in intervention and 22 in control) completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group', 'description': 'Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.\n\nAdapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Participants in the control group received no intervention in the study time period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The analysis was performed on subjects who completed the entire study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-04', 'size': 842398, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-18T06:55', 'hasProtocol': True}, {'date': '2018-04-04', 'size': 1060451, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-02-18T06:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-12', 'studyFirstSubmitDate': '2020-06-28', 'resultsFirstSubmitDate': '2020-11-10', 'studyFirstSubmitQcDate': '2020-07-08', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-19', 'studyFirstPostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMI Change', 'timeFrame': 'Change from baseline at 4 months and 9 months', 'description': 'The primary outcome variable was change in BMI (weight (kg) / height2 (m)) that was further calculated from the height and weight measured at school in the morning time. Height was measured to the nearest 0.1 cm using a stadiometer and weight was measured to the nearest 0.1 kg on a TANITA digital scale (TBF-410) with the subject wearing lightweight clothing and no shoes.'}], 'secondaryOutcomes': [{'measure': 'BMIz Change', 'timeFrame': 'Change from baseline at 4 months and 9 months', 'description': 'The BMIz was converted from the BMI values using WHO 2007 reference standards. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values denote a higher BMI.'}, {'measure': 'Weight Change', 'timeFrame': 'Change from baseline at 4 months and 9 months', 'description': 'Weight was measured to the nearest 0.1 kg on a calibrated TANITA digital scale (TBF-410) with the subject wearing lightweight clothing and no shoes.'}, {'measure': 'Percent Body Fat Change', 'timeFrame': 'Change from baseline at 4 months and 9 months', 'description': 'Percent body fat was measured with the TANITA digital scale (TBF-410) using foot-to-foot bioelectrical impedance analysis.'}, {'measure': 'Waist Circumference Change', 'timeFrame': 'Change from baseline at 4 months and 9 months', 'description': 'Waist circumference (cm) was measured with a flexible meter ribbon accurate to 0.1 cm at the midway between the lowest rib margin and the top of the iliac crest at the end of gentle expiration'}, {'measure': 'Waist-to-height Ratio Change', 'timeFrame': 'Change from baseline at 4 months and 9 months', 'description': 'Waist-to-height ratio was calculated by dividing the waist circumference by the height.'}, {'measure': 'Cardiorespiratory Fitness Change', 'timeFrame': 'Change from baseline at 4 months and 9 months', 'description': 'Cardiorespiratory fitness was assessed using the 9-minute run/walk test. The test measured how far a person can cover a flat surface 25 meters in length over a 9-minute period.'}, {'measure': 'Muscular Strength and Endurance Change', 'timeFrame': 'Change from baseline at 4 months and 9 months', 'description': 'The muscular strength and endurance were measured by handgrip strength and sit-ups. The handgrip strength was measured using a dynamometer (Takei, TKK5001, GRIP-A digital dynamometer). The sit-ups measured the total number of correctly completed sit-ups performed in 30 seconds.'}, {'measure': 'Flexibility Change', 'timeFrame': 'Change from baseline at 4 months and 9 months', 'description': 'Flexibility was measured by the sit-and-reach test.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adolescents', 'intellectual disability', 'overweight', 'obesity', 'physical activity', 'intervention'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'Considering that children with intellectual disability (ID) might be more vulnerable to obesity than their counterparts in the general population. This study aimed to develop and evaluate the effectiveness of an adapted physical activity (APA) program in reducing weight among adolescents with ID. The hypothesis of the study was the APA program would be able to decrease obesity among adolescents with ID.', 'detailedDescription': 'Background: Children with intellectual disability (ID) might be more vulnerable to obesity than their counterparts in the general population. This study aimed to evaluate the effectiveness of an adapted physical activity (APA) program in reducing weight among adolescents with ID.\n\nMethods: A 9-month randomized controlled trial of a school-based APA program was conducted in adolescents with ID and overweight/obesity in Hong Kong. The intervention group received the APA program which consisted of endurance and strength-building exercises at a frequency of two sessions per week, while the control group received routine PE classes as usual. Data on obesity-related variables were collected before the intervention, at the midpoint of the intervention and after the intervention. Linear mixed-effect models were used to examine the intervention effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 12 and 18 years\n* overweight and obesity\n* mild or moderate intellectual disability\n\nExclusion Criteria:\n\n* physical disability\n* medical predispositions towards obesity (genetic syndrome or drug treatment)\n* contraindications (e.g. asthma, heart disease)\n* having participated in other exercise programs in the past 6 months.'}, 'identificationModule': {'nctId': 'NCT04463069', 'briefTitle': 'School-based Physical Activity Intervention for Obesity Among Adolescents With Intellectual Disability in Hong Kong', 'organization': {'class': 'OTHER', 'fullName': 'Hong Kong Baptist University'}, 'officialTitle': 'School-based Physical Activity Intervention for Obesity Among Adolescents With Intellectual Disability in Hong Kong', 'orgStudyIdInfo': {'id': '30160054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.', 'interventionNames': ['Other: Adapted physical activity']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Participants in the control group received no intervention in the study time period.'}], 'interventions': [{'name': 'Adapted physical activity', 'type': 'OTHER', 'description': 'This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.', 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': 'Hong Kong Bapist University', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Yang Gao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hong Kong Baptist University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hong Kong Baptist University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Gao Yang', 'investigatorAffiliation': 'Hong Kong Baptist University'}}}}