Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT03469869
Status:
COMPLETED
Last Update Posted:
2019-02-25
First Post:
2018-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Balanced and Sustainable Diet Application for Insulin Resistance and Inflammation Marker of Obese People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Giving a spesific personal menu through android apps, one group with balance diet menu, and the other with balance and sustainable diet menu. Only di IT knows which person get which type of menu'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'One group balance diet One group balance and sustainable diet'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-22', 'studyFirstSubmitDate': '2018-02-27', 'studyFirstSubmitQcDate': '2018-03-12', 'lastUpdatePostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of body weight', 'timeFrame': 'baseline at Day0 and endline at Day56', 'description': 'Change from baseline body weight at 8 weeks, is measured in kg'}], 'secondaryOutcomes': [{'measure': 'Change of Fat Mass', 'timeFrame': 'baseline at Day0 and endline at Day56', 'description': 'Change from baseline Fat Mass at 8 weeks, is measured by body composition analyzer in kg'}, {'measure': 'Change of Fasting plasma glucose', 'timeFrame': 'baseline at Day0 and endline at Day56', 'description': 'Change from baseline Fasting plasma glucose at 8 weeks, is measured in mg/dL'}, {'measure': 'Change of TNF alpha', 'timeFrame': 'baseline at Day0 and endline at Day56', 'description': 'Change from baseline TNF alpha at 8 weeks, is measured in pg/ml'}, {'measure': 'Change of Fasting Insulin', 'timeFrame': 'baseline at Day0 and endline at Day56', 'description': 'Change from baseline Fasting Insulin at 8 weeks, is measured in µU/mL'}, {'measure': 'Change of HOMA-IR', 'timeFrame': 'baseline at Day0 and endline at Day56', 'description': 'Change from baseline HOMA-IR at 8 weeks, is measured using formulation : glukosa (mg/dL) x insulin (µU/mL)/405'}, {'measure': 'Change of Waist Circumference', 'timeFrame': 'baseline at Day0 and endline at Day56', 'description': 'Change from baseline Waist Circumference at 8 weeks, is measured in cm'}, {'measure': 'Change of Carbohydrate intake', 'timeFrame': 'baseline at Day0 and endline at Day56', 'description': 'Change from baseline Carbohydrate intake at 8 weeks, is measured in gram using 24HR-recall'}, {'measure': 'Change of Fat intake', 'timeFrame': 'baseline at Day0 and endline at Day56', 'description': 'Change from baseline Fat intake at 8 weeks, is measured in gram using 24HR-recall'}, {'measure': 'Change of Protein intake', 'timeFrame': 'baseline at Day0 and endline at Day56', 'description': 'Change from baseline Protein intake at 8 weeks, is measured in gram using 24HR-recall'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity'], 'conditions': ['Obesity', 'Insulin Resistance', 'Inflammation', 'Blood Glucose, High']}, 'referencesModule': {'references': [{'pmid': '35725407', 'type': 'DERIVED', 'citation': 'Agustina R, Febriyanti E, Putri M, Martineta M, Hardiany NS, Mustikawati DE, Hanifa H, Shankar AH. Development and preliminary validity of an Indonesian mobile application for a balanced and sustainable diet for obesity management. BMC Public Health. 2022 Jun 20;22(1):1221. doi: 10.1186/s12889-022-13579-x.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of balanced and sustainable diet application on fat composition, insulin resistance and inflammation marker in obese people.\n\nIntervention: Obese subject will receive intervention on balanced and sustainable diet application Control: Obese subject will receive a balanced diet application only', 'detailedDescription': 'Maintaining the adherence of weight loss programme while selecting healthy and sustainable foods will become a worldwide future challenge in nutrition. Therefore, we investigated the suitable content, graphic, and flow in developing a mobile application as an alternative solution for enhancing the compliance of weight control and selecting healthy food with the least environmental impact.\n\nThe treatment for obesity consists of dieting, physical exercise, pharmacology, and surgery. Restricted balanced diet is a well known diet recommendation for people with obesity. Sustainable diet is an alternative form of diet which contributes to healthy life and is protective of biodiversity.\n\nThe main challenge in obesity management is the sustainability of weight loss programme. Mobile apps are an alternative solution for enhancing compliance.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index ≥ 25 kg/m2\n* using Android-based smartphone\n* willing to join this research by signing informed consent\n\nExclusion Criteria:\n\n* pale in physical examination\n* in weight loss program\n* have obesity with comorbidities\n* have hormonal diseases\n* consumed hormonal drug, PTU, anti diabetes drug\n* smoking or stop smoking under 2 years\n* pregnant and breastfeeding women'}, 'identificationModule': {'nctId': 'NCT03469869', 'briefTitle': 'Effects of Balanced and Sustainable Diet Application for Insulin Resistance and Inflammation Marker of Obese People', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'The Effect of Balanced and Sustainable Diet for Insulin Resistance and Inflammation Marker of Obese Adults in Indonesia', 'orgStudyIdInfo': {'id': 'YULIA-SAMI project'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'balanced and sustainable diet', 'description': 'The intervention group will receive menu recommendation of restriction calorie balanced and sustainable diet for 8 weeks. the control group will receive menu recommendation of balanced diet for 8 weeks. these menus are given in the apps', 'interventionNames': ['Other: balanced and sustainable diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'balanced diet', 'description': 'the intervention group receive get menu recommendation of restriction calorie balanced and sustainable diet for 8 weeks. the other group will receive menu recommendation of balanced diet for 8 weeks. these menus are given in the apps', 'interventionNames': ['Other: balanced and sustainable diet']}], 'interventions': [{'name': 'balanced and sustainable diet', 'type': 'OTHER', 'description': 'the intervention group will get menu recommendation of restriction calorie balanced and sustainable diet for 8weeks. the other group will get menu recommendation of balanced diet for 8 weeks. these menus are given in the apps named EatsUp.\n\nthe intervention group will get menu recommendation of restriction calorie balanced and sustainable diet for 8 weeks. the other group will get menu recommendation of balanced diet for 8 weeks. these menus are given in the apps named EatsUp.', 'armGroupLabels': ['balanced and sustainable diet', 'balanced diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16424', 'city': 'Depok', 'state': 'West Java', 'country': 'Indonesia', 'facility': 'University of Indonesia', 'geoPoint': {'lat': -6.4, 'lon': 106.81861}}], 'overallOfficials': [{'name': 'Rina Agustina, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fakultas Kedokteran Universitas Indonesia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Human Nutrition Research Center', 'investigatorFullName': 'Rina Agustina', 'investigatorAffiliation': 'Indonesia University'}}}}