Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-20 @ 10:58 PM
Study NCT ID:
NCT05181293
Status:
COMPLETED
Last Update Posted:
2025-03-28
First Post:
2021-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Gaming App to Improve Child Nutrition in Nigeria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015362', 'term': 'Child Nutrition Disorders'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2021-12-17', 'studyFirstSubmitQcDate': '2021-12-17', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infant and Young Child Feeding (IYCF) knowledge and practice scores of teenage mothers', 'timeFrame': 'Baseline, Month 6 of intervention', 'description': 'Mean change in scores from baseline, after 6 months of intervention. Measured at baseline and at 6 months after the intervention, using the Teen Moms IYCF Questionnaire (to be validated at the beginning of this study)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Child Malnutrition', 'Behavior, Maternal']}, 'descriptionModule': {'briefSummary': 'Undernutrition among children born to teenage mothers deserves urgent attention in Nigeria, where 27.2% of girls (15-19 years) living in rural areas have begun childbearing. The overall goal of this study is to develop, validate and evaluate the effects of a mobile gaming app on the infant and young child feeding practices of teenage mothers, and the nutritional status of children (0 - 2 years).', 'detailedDescription': 'Undernutrition among children born to teenage mothers deserves urgent attention in Nigeria, where 27.2% of girls (15-19 years) living in rural areas have begun childbearing. Pregnancy elevates the nutrient needs of teenage girls due to competing requirements for fetal development, and growth and maturity in the adolescent mother. The resultant children have a higher likelihood of underweight (13-fold), stunting (8-fold) and wasting (3-fold), and are over 50% more likely to die within the first month of birth, as compared to children of older mothers. Previous studies have found positive associations between maternal education/knowledge and optimum infant and young child feeding (IYCF) practices. Childbirth results in a sharp increase in the responsibilities and work burden of teenage mothers, negatively impacting capacity and self-efficacy for adequate child feeding. Furthermore, attempts to improve IYCF practices often target older women. The overall goal of this study is to develop, validate and evaluate the effects of a mobile gaming app on the infant and young child feeding practices of teenage mothers. A secondary goal is to evaluate the anthropometric and dietary and plasma levels of microminerals of children, 0 - 24 months of age. A mobile app will be developed and validated. It will feature an interactive role-play game on recommended IYCF practices that will help educate teenage mothers about feeding young children. A 6-month randomized controlled trial (RCT) will be conducted in 266 predominantly low-income mother-child dyads (0 - 24 months) from Nigeria. This RCT will compare the influence of the BabyThrive app vs controls who receive a delayed intervention. It will include knowledge and practices regarding exclusive breastfeeding, introduction to solid/semi-solid foods, meal frequency, dietary diversity and amount of food consumed of teenage mothers. Anthropometric measurements and plasma ferritin and zinc of children also will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '0 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Teenage mothers with children aged 0 - 24 months\n\nExclusion Criteria:\n\n* Children with acute infections, metabolic or feeding issues\n* Mothers younger than 14 years of age\n* HIV-positive mothers'}, 'identificationModule': {'nctId': 'NCT05181293', 'briefTitle': 'Mobile Gaming App to Improve Child Nutrition in Nigeria', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'Impact of a Mobile Gaming App on Infant and Young Child Feeding Practices of Teenage Mothers, and Nutritional Status of Children (0 - 24 Months) in Nigeria', 'orgStudyIdInfo': {'id': 'STUDY00001047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'A mobile gaming app (BabyThrive) will be disseminated to teenage mothers to help them learn about exclusive breastfeeding, introduction to solid/semi-solid foods, meal frequency and dietary diversity. BabyThrive will also demonstrate how to prepare 30 nutritious recipes for complementary feeding; create a calendar and set reminders to prompt mothers to access child health services; and plot growth patterns of the baby to facilitate growth monitoring.', 'interventionNames': ['Behavioral: Mobile Gaming App for Nutrition Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention', 'description': 'In addition to routine health services, teenage mothers will receive the BabyThrive app after the intervention is completed. Participants will learn about exclusive breastfeeding, introduction to solid/semi-solid foods, meal frequency and dietary diversity. BabyThrive also will demonstrate how to prepare 30 nutritious recipes for complementary feeding; create a calendar and set reminders to prompt mothers to access child health services; and plot growth patterns of baby to facilitate growth monitoring.'}], 'interventions': [{'name': 'Mobile Gaming App for Nutrition Intervention', 'type': 'BEHAVIORAL', 'description': 'A mobile gaming app (BabyThrive) will be disseminated to teenage mothers to help them learn about exclusive breastfeeding, introduction to solid/semi-solid foods, meal frequency and dietary diversity. BabyThrive will also demonstrate how to prepare 30 nutritious recipes for complementary feeding; create a calendar and set reminders to prompt mothers to access child health services; and plot growth patterns of the baby to facilitate growth monitoring.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abuja', 'state': 'Federal Capital Territory', 'country': 'Nigeria', 'facility': 'Center for Family Health Initiative', 'geoPoint': {'lat': 9.05785, 'lon': 7.49508}}], 'overallOfficials': [{'name': 'Jeanne H Freeland-Graves, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas at Austin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The Bess Heflin Centennial Professor', 'investigatorFullName': 'Jeanne Freeland-Graves', 'investigatorAffiliation': 'University of Texas at Austin'}}}}