Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT06247202
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2024-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Smart Phone Health Education on Overweight and Obese Schoolchildren's Dietary Habits and Body Composition
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003226', 'term': 'Congresses as Topic'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Lab technician who will handle the saliva analysis and the person who will be doing the statistical analysis will be blinded of any data related to the grouping of the participants.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly divided into intervention group and control group.\n\nintervention group will receive smart phone delivered nutrition education while control group will receive paper delivered nutrition education.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-11', 'studyFirstSubmitDate': '2024-01-07', 'studyFirstSubmitQcDate': '2024-01-30', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': '3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)', 'description': 'Will be measured using a Body Composition Analyzer, and will be measured in Kilograms'}, {'measure': 'Height', 'timeFrame': '3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)', 'description': 'Will be measured using a standing Stadiometer, and will be measured in Centimetres'}, {'measure': 'Body Mass Index', 'timeFrame': '3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)', 'description': 'Will be calculated using the weight and height, and will be measured in kg/m\\^2'}, {'measure': 'Body Fat Mass', 'timeFrame': '3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)', 'description': 'Will be measured using a Body Composition Analyzer, and will be measured in Kilograms'}, {'measure': 'Fat Free Mass', 'timeFrame': '3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)', 'description': 'Will be measured using a Body Composition Analyzer, and will be measured in Kilograms'}, {'measure': 'Total Body Water', 'timeFrame': '3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)', 'description': 'Will be measured using a Body Composition Analyzer, and will be measured in Kilograms'}, {'measure': "Parents' Knowledge", 'timeFrame': 'twice: before intervention (at 0 months) and after intervention (at 3 months).', 'description': 'Using a valid Nutrition Knowledge Attitude Practice Questionnaire - no scale'}, {'measure': "Children's Dietary Intake", 'timeFrame': '3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)', 'description': "Using 24 Hours' Diet recall (3 days)."}, {'measure': "Children's Physical Activity", 'timeFrame': '3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)', 'description': 'Using a valid Physical Activity Questionnaire - no scale'}, {'measure': 'Salivary C-Reactive Protein Concentration', 'timeFrame': 'twice: before intervention (at 0 months) and after intervention (at 3 months).', 'description': 'Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)'}, {'measure': 'Salivary Adiponectin (Acrp30) Concentration', 'timeFrame': 'twice: before intervention (at 0 months) and after intervention (at 3 months).', 'description': 'Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)'}, {'measure': 'Salivary Monocyte Chemoattractant Protein-1 (MCP-1/CCL2) Concentration', 'timeFrame': 'twice: before intervention (at 0 months) and after intervention (at 3 months).', 'description': 'Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)'}, {'measure': 'Salivary Complement Factor D (Adipsin) Concentration', 'timeFrame': 'twice: before intervention (at 0 months) and after intervention (at 3 months).', 'description': 'Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)'}, {'measure': 'Salivary Interleukin 6 (IL-6) Concentration', 'timeFrame': 'twice: before intervention (at 0 months) and after intervention (at 3 months).', 'description': 'Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)'}, {'measure': 'Salivary Interleukin 10 (IL-10) Concentration', 'timeFrame': 'twice: before intervention (at 0 months) and after intervention (at 3 months).', 'description': 'Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)'}, {'measure': 'Salivary Leptin (OB) Concentration', 'timeFrame': 'twice: before intervention (at 0 months) and after intervention (at 3 months).', 'description': 'Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)'}, {'measure': 'Salivary Resistin Concentration', 'timeFrame': 'twice: before intervention (at 0 months) and after intervention (at 3 months).', 'description': 'Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)'}, {'measure': 'Salivary Plasminogen Activator Inhibitor-1 (Serpin E1 / PAI-1) Concentration', 'timeFrame': 'twice: before intervention (at 0 months) and after intervention (at 3 months).', 'description': 'Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)'}, {'measure': 'Salivary Tumour Necrosis Factor alpha (TNF alpha) Concentration', 'timeFrame': 'twice: before intervention (at 0 months) and after intervention (at 3 months).', 'description': 'Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Childhood Obesity']}, 'descriptionModule': {'briefSummary': "The aim of this study is to investigate the effect of mobile health nutrition education intervention in the changing of dietary habits and body composition of overweight and obese 8-12 years old children in Sharjah, United Arab Emirates and to compare its effectiveness to paper educational intervention among the same age group.\n\nThe main questions it aims to answer are:\n\n1. Are there any significant changes in dietary habits, physical activity and body composition among overweight and obese school-age children after three months of mobile health intervention?\n2. Is there any significant difference between the effect of smart phone delivered and paper delivered interventions (changes in dietary habits, physical activity and body composition) among overweight and obese school-age children after three months of interventions?\n3. Are there any significant changes in the obesity inflammatory panel among overweight and obese school-age children after three months of mobile health intervention?\n4. Is there any significant difference in the sustainability of the outcomes between mobile health and paper delivered interventions among overweight and obese school-age children two months after the end of the intervention?\n5. Are there any significant changes in nutrition related knowledge among parents of overweight and obese school-age children after three months of intervention?\n\nParticipants (children with their parents) will be randomly divided into intervention group and control group. Parents of children from the intervention group will receive two text messages/graphics per week about healthy eating and physical activity (PA) on their mobile phones during the intervention period (3 months). While parents in the control group will receive a one-time printed handout containing the same messages at the beginning of the intervention period.\n\nAssessment of children's anthropometry, dietary intake and physical activity will be evaluated pre and post intervention and one more time after a two months period of maintenance after the end of the intervention. Parents' nutrition knowledge will be evaluated pre and post intervention only. Also, children salivary obesity markers will be measured at baseline and at the end of the intervention period to explore the effects of the intervention on inflammatory markers associated with obesity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight/obese children (over 2 SD based on the WHO Growth Reference (2007)).\n* Between 8 - 12 years old.\n* Attending school in Sharjah, UAE.\n\nExclusion Criteria:\n\n* Children on a specific diet.\n* Children who have any chronic diseases.\n\nParents qualify if their children meet the inclusion criteria, they can read and speak in Arabic, they plan to stay in Sharjah for six months from the beginning of the intervention, and they own and use a smart phone.'}, 'identificationModule': {'nctId': 'NCT06247202', 'acronym': 'mHealth', 'briefTitle': "Effect of Smart Phone Health Education on Overweight and Obese Schoolchildren's Dietary Habits and Body Composition", 'organization': {'class': 'OTHER', 'fullName': 'Universiti Sains Malaysia'}, 'officialTitle': "Effect of Smart Phone Delivered Health Education Intervention on Overweight and Obese Schoolchildren's Dietary Habits and Body Composition in the UAE", 'orgStudyIdInfo': {'id': 'USM/JEPeM/KK/23020205'}, 'secondaryIdInfos': [{'id': 'REC-22-09-05-01', 'type': 'OTHER', 'domain': 'University of Sharjah'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Participants in the intervention group will receive smart phone delivered health education in the form of text messages through WhatsApp.', 'interventionNames': ['Other: Smart Phone Education (mhealth)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Participants in the control group will receive paper delivered health education in the form of a one time handout.', 'interventionNames': ['Other: Paper Education (conventional)']}], 'interventions': [{'name': 'Smart Phone Education (mhealth)', 'type': 'OTHER', 'description': 'Nutrition and Health Education module delivered through m-health approach (smart phones)', 'armGroupLabels': ['Intervention group']}, {'name': 'Paper Education (conventional)', 'type': 'OTHER', 'description': 'Nutrition and Health Education module delivered through conventional approach (paper)', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sharjah city', 'country': 'United Arab Emirates', 'facility': 'University of Sharjah', 'geoPoint': {'lat': 25.3342, 'lon': 55.41221}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Sains Malaysia', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Sharjah', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Heba Mustafaalsaafin', 'investigatorAffiliation': 'Universiti Sains Malaysia'}}}}