Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-31 @ 2:27 PM
Study NCT ID:
NCT02228434
Status:
COMPLETED
Last Update Posted:
2014-08-29
First Post:
2014-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Tailored Intervention Strategy of Childhood Obesity Based on Monitoring Physical Activities and Dietary Behaviors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'lastUpdateSubmitDate': '2014-08-27', 'studyFirstSubmitDate': '2014-08-27', 'studyFirstSubmitQcDate': '2014-08-27', 'lastUpdatePostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body mass index', 'timeFrame': 'Baseline, 1-year post-intervention'}], 'secondaryOutcomes': [{'measure': 'Change in obesity-related anthropometric measurements', 'timeFrame': 'Baseline, 1-year post-intervention'}, {'measure': 'Change of blood pressure', 'timeFrame': 'Baseline, 1-year post-intervention'}, {'measure': 'Change of biomarkers for disease risk', 'timeFrame': 'Baseline, 1-year post-intervention'}, {'measure': 'Change of attitude, knowledge, and behaviors on dietary and physical activity', 'timeFrame': 'Baseline, 1-year post-intervention'}]}, 'conditionsModule': {'keywords': ['Childhood obesity, intervention, effectiveness, comparison'], 'conditions': ['Pediatric Obesity']}, 'referencesModule': {'references': [{'pmid': '26635229', 'type': 'DERIVED', 'citation': 'Wang JJ, Lau WC, Wang HJ, Ma J. Evaluation of a comprehensive intervention with a behavioural modification strategy for childhood obesity prevention: a nonrandomized cluster controlled trial. BMC Public Health. 2015 Dec 3;15:1206. doi: 10.1186/s12889-015-2535-2.'}]}, 'descriptionModule': {'briefSummary': 'The project aims at developing the tailored intervention strategy of childhood obesity based on monitoring physical activities with accelerometer and dietary behaviors using diary. It probably raise the passion of obese children to control weight, form healthy life style, be effective in sustaining weight loss and early prevent adulthood diseases.', 'detailedDescription': 'The overweight and obese primary school students from 1-5 grades will be recruited according to "Body Mass Index Reference for Screening Overweight and Obesity in Chinese School-age Children". The participants with will be allocated with schools as the unit to four groups: tailored intervention based on monitoring physical activity and dietary behaviors, exercise intervention group based on the Happy 10 program, nutrition education intervention group. The three intervention groups received the designed interventions for the duration of 1 year. Before and after the intervention, we will carry out a questionnaire survey, a physical measurement, a fitness test, and a metabolic markers detection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight and obese children from grade 1-5 primary schools\n\nExclusion Criteria:\n\n* Students with any contraindication or physical diseases (heart, Lung, liver, kidney, other vital organs, endocrine diseases and drug side effects et al.) and psychological illnesses that may prevent them from participating in physical activity and eating a normal diet were excluded'}, 'identificationModule': {'nctId': 'NCT02228434', 'briefTitle': 'Study on the Tailored Intervention Strategy of Childhood Obesity Based on Monitoring Physical Activities and Dietary Behaviors', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Study on the Tailored Intervention Strategy of Childhood Obesity Based on Monitoring Physical Activities and Dietary Behaviors', 'orgStudyIdInfo': {'id': 'IRB00001052-10081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tailored intervention group', 'description': 'For the monitoring session, physical activity was assessed by accelerometer and dietary was assessed by diary. Based on the monitoring information, the individual tailored prescription, including the normative feedback and process feedback, were formed and delivered to children and parents. Children were encouraged to modify the behaviors according to the prescription.\n\nThen, next monitoring circle was followed. In total, 7 monitoring round were completed.', 'interventionNames': ['Behavioral: Monitoring and Tailored prescription', 'Behavioral: General Health Education']}, {'type': 'EXPERIMENTAL', 'label': 'Happy 10 exercise group', 'description': 'All the schools participating in this group were encouraged to take two Happy 10 sessions on each school day.', 'interventionNames': ['Behavioral: Happy 10 program', 'Behavioral: General Health Education']}, {'type': 'EXPERIMENTAL', 'label': 'Nutrition education group', 'description': 'The nutrition intervention was mainly conducted based on the nutrition knowledge through health education lectures given by researchers. The lectures were given for eight times to students and twice to parents. Each lecture session lasted no less than 40 min.', 'interventionNames': ['Behavioral: Specified nutrition education', 'Behavioral: General Health Education']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Receive no intervention'}], 'interventions': [{'name': 'Monitoring and Tailored prescription', 'type': 'BEHAVIORAL', 'otherNames': ['ZhiJi accelerometer UX-02 as physical activity monitor'], 'armGroupLabels': ['Tailored intervention group']}, {'name': 'Happy 10 program', 'type': 'BEHAVIORAL', 'otherNames': ['happy 10 program developed by Center for Disease Control and Prevention, China'], 'armGroupLabels': ['Happy 10 exercise group']}, {'name': 'Specified nutrition education', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Nutrition education group']}, {'name': 'General Health Education', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Happy 10 exercise group', 'Nutrition education group', 'Tailored intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'country': 'China', 'facility': 'Insitute of Child and Adolescent Health, Peking University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wang Jingjing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Institute of Child and Adolescent Health', 'investigatorFullName': 'Wang Jingjing', 'investigatorAffiliation': 'Peking University'}}}}