Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-01-01 @ 7:03 AM
Study NCT ID:
NCT06921135
Status:
COMPLETED
Last Update Posted:
2025-04-10
First Post:
2025-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutrition of Urban-poor Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015362', 'term': 'Child Nutrition Disorders'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}], 'ancestors': [{'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will be a retrospective pre-post interventional study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2025-04-07', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minimum Dietary diversity score', 'timeFrame': 'Pre and post intervention, at least 4 months interval', 'description': 'The percentage of children who achieved the minimum dietary diversity score of 5 food groups, based on WHO 8 food groups and 24-hour dietary recall.'}, {'measure': 'Consumption of healthy foods', 'timeFrame': 'Pre and post intervention, at least 4 months interval', 'description': 'The percentage of children who consume fresh fruits and/or vegetables pre- and post-intervention.'}, {'measure': 'Consumption of unhealthy foods', 'timeFrame': 'Pre and post intervention, at least 4 months interval', 'description': 'The percentage of children who consume sugar-sweetened foods or beverages.'}], 'secondaryOutcomes': [{'measure': "Child's weight z-scores", 'timeFrame': 'Pre and post intervention, at least 4 months interval', 'description': 'Weight is measured in kilograms Weight will be adjusted for age and sex, i.e., Weight for age Z-score'}, {'measure': "Child's Height z-scores", 'timeFrame': 'Pre and post intervention, at least 4 months interval', 'description': 'Height is measured centimeters, adjusted for age and sex: Height-for-age Z-score'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dietary diversity', 'Food supplement', 'malnutrition in children', 'Healthy food choice', 'sugar sweetened beverages and food'], 'conditions': ['Dietary Assessment', 'Growth', 'Nutritional Assessment']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.jpeds.2016.05.013', 'label': 'The Role of Nutrition in Brain Development: The Golden Opportunity of the "First 1000 Days"'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/29358479/', 'label': 'Advocacy for Improving Nutrition in the First 1000 Days to Support Childhood Development and Adult Health'}, {'url': 'https://doi.org/10.3945/jn.108.093971', 'label': 'Moursi, M., Arimond, M., Dewey, K., Trè€che, S., Ruel, M., \\& Delpeuch, F. (2008). Dietary Diversity Is a Good Predictor of the Micronutrient Density of the Diet of 6- to 23-Month-Old Children in Madagascar.'}, {'url': 'https://apps.who.int/iris/bitstream/handle/10665/43895/9789241596664_eng.pdf;sequence=1', 'label': 'World Health Organization. Indicators for assessing infant and young child feeding practices Part 1: Definitions. Geneva: WHO; 2008.'}]}, 'descriptionModule': {'briefSummary': 'The investigators undertook a program to promote the consumption of healthy foods and reduce the prevalence of malnutrition of children below the age of 5 years in an urban-poor community, by 10% year-on-year through nutrition education and the provision of healthy food. The main purpose of the study is to determine the impact of these nutrition intervention programs on the nutritional status of children under-5 in Selangor.\n\nThis retrospective pre-post intervention study will use data collected from 2 previous studies that were carried out between July 2020 to May 2021 (Eat Healthy Project 1.0) and March 2022 to December 2023 (Eat Healthy Project 2.0). The 2 studies had been approved by the Medical Research and Ethics Committees of University Malaya Medical Centre (UMMC) and the Ministry of Health, Malaysia and registered with the National Medical Research Registry (NMRR).\n\nThe main outcome measures were:\n\n1. Improved dietary practices, in particular, an increase in the proportion of children who meet the minimum dietary diversity score of 5 food groups, post-intervention.\n2. An increase in proportion of children consuming fruits and vegetables and a decrease in proportion of children consuming sugar-sweetened foods and beverages post-intervention.\n3. A decrease in prevalence of malnutrition - underweight, wasting and stunting. The comparator will be urban-poor children attending a Child Health clinic who had received nutritional education but no provision of food supplementation.', 'detailedDescription': 'The primary objectives:\n\n1. To compare dietary diversity practices of children, based on the WHO 8 food groups and 24-hour dietary recall, pre- and post-intervention.\n2. To compare consumption of fresh foods, sugar-sweetened foods and beverages pre- and post-intervention.\n\n The secondary objectives:\n3. To compare the weight-for-age z-scores of children pre- and post-intervention.\n4. To compare the height-for-age z-scores of children pre- and post-intervention.\n5. To compare the prevalence of malnutrition: underweight, stunting and wasting pre- and post-intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '6 Months', 'genderBased': False, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children aged under 5 years enrolled at PPR Lembah Subang 1 or\n* children aged under 5 years enrolled at the Child Health Clinic, Universiti Malaya Medical Center\n\nExclusion Criteria:\n\n* Children with low birth weight (\\<2.5 kg)\n* Children born pre-term (\\<37 weeks gestation) and\n* Children with chronic illnesses or severe malnutrition.'}, 'identificationModule': {'nctId': 'NCT06921135', 'briefTitle': 'Nutrition of Urban-poor Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'The Impact of Nutritional Intervention in Young Children in PPR Lembah Subang 1: A Retrospective Study', 'orgStudyIdInfo': {'id': 'Version 1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Community', 'description': 'Regular food supplementation.', 'interventionNames': ['Dietary Supplement: supplementation, food']}, {'type': 'NO_INTERVENTION', 'label': 'Child Health Clinic', 'description': 'No food supplementation.'}], 'interventions': [{'name': 'supplementation, food', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Supplementation of fresh foods', 'armGroupLabels': ['Community']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Kuala Lumpur', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Universiti of Malaya Medical Center', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}]}, 'ipdSharingStatementModule': {'url': 'https://data.mendeley.com/research-data/?', 'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'December 2025 to November 2026', 'ipdSharing': 'YES', 'description': 'IPD used in results publication', 'accessCriteria': 'To request for access from the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}