Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-02-06 @ 5:12 AM
Study NCT ID:
NCT04082195
Status:
COMPLETED
Last Update Posted:
2019-09-09
First Post:
2019-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of A Mobile Game on Pediatric Nutrition and Physical Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2016-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-05', 'studyFirstSubmitDate': '2019-09-05', 'studyFirstSubmitQcDate': '2019-09-05', 'lastUpdatePostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Actual food choice', 'timeFrame': 'Immediately after the intervention', 'description': 'The children were offered a selection of food items to choose from, and the actual selection were documented.'}], 'secondaryOutcomes': [{'measure': 'Subjective food choice', 'timeFrame': 'Immediately after the intervention', 'description': 'The children completed surveys to indicate their preferred food items among a list'}, {'measure': 'Knowledge of healthy eating', 'timeFrame': 'Immediately after the intervention', 'description': 'The children completed surveys to indicate their knowledge of healthy eating practice'}, {'measure': 'Knowledge of physical activity', 'timeFrame': 'Immediately after the intervention', 'description': 'The children completed surveys to indicate their knowledge of physical activity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Nutrition']}, 'referencesModule': {'references': [{'pmid': '33206054', 'type': 'DERIVED', 'citation': 'Kato-Lin YC, Kumar UB, Sri Prakash B, Prakash B, Varadan V, Agnihotri S, Subramanyam N, Krishnatray P, Padman R. Impact of Pediatric Mobile Game Play on Healthy Eating Behavior: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Nov 18;8(11):e15717. doi: 10.2196/15717.'}]}, 'descriptionModule': {'briefSummary': 'Overweight and obesity in children is on the rise globally and is rapidly growing in urban India. Studies have revealed that obesity is on the rise among children in India with many of them suffering from the problem even before they reach adolescence.\n\nAs many as 30 million Indians are overweight, and obesity continues to rise. The National Family Health Survey (NFHS) found that 20% of school children are overweight. NFHS is a large-scale, multi-round survey conducted in a representative sample of households throughout India. The findings from the survey indicate that the prevalence of obesity is increasing in India along with the epidemic proportions worldwide especially in developed countries.\n\nOverweight or obesity is the leading cause of type 2 diabetes, gestational diabetes, hypertension, osteoarthritis, various types of cancers in women like breast cancer and uterine cancer, menstrual disorder and infertility and many more diseases.\n\nTo decrease prevalence you have to decrease incidence. More and more young people are at risk of developing diseases like diabetes and if the number of children living with these diseases has to come down, focus has to be on addressing the risk factors and moving the population to a healthier lifestyle through health education/ communication and motivation. To design appropriate interventions for behaviour formation and change, we need to learn more about the underlying factors affecting these unhealthy behaviours.\n\nThis study was conducted by the Center for Communication and Change - India, in partnership with the Johns Hopkins Bloomberg School of Public Health Center for Communication Programs, and FriendsLearn (California).\n\nStudy Purpose\n\nThe specific aim of this research study is to assess the awareness levels among urban, Indian children, with respect to diet and lifestyle behaviours, while also evaluating the influence of a digital health education intervention - fooya!™ among school-age children in India. Specifically, the study objectives will be:\n\n1. Quantify the effectiveness of a digital health education intervention- fooya (an application) on health awareness around eating right and physical activity\n2. Find out the current diet and physical activity among urban, children in India and the factors that affect them\n3. Assess the extent of their awareness about eating right and physical activity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* class (grade) 5 students\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04082195', 'briefTitle': 'Impact of A Mobile Game on Pediatric Nutrition and Physical Activity', 'organization': {'class': 'OTHER', 'fullName': 'Center for Communication and Change India'}, 'officialTitle': 'Impact of Digital Health Education Intervention - Fooya on Health Awareness Around Eating Right and Physical Activity of School Going Children in Chennai', 'orgStudyIdInfo': {'id': 'IRB00006230'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fooya mobile game', 'description': 'An arm that receives a mobile-app-based treatment.', 'interventionNames': ['Other: Fooya mobile game']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Uno board game', 'description': 'An arm that receives a non mobile-app-based treatment.', 'interventionNames': ['Other: Uno board game']}], 'interventions': [{'name': 'Fooya mobile game', 'type': 'OTHER', 'description': 'An application that incorporates the science and technology of immersive gaming, neuropsychology and cognitive behavior therapy in a mobile health game to target early childhood nutrition literacy and health promotion in a fun and exciting way.', 'armGroupLabels': ['Fooya mobile game']}, {'name': 'Uno board game', 'type': 'OTHER', 'description': 'A popular board game which is not a mobile app.', 'armGroupLabels': ['Uno board game']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Communication and Change India', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'Carnegie Mellon University', 'class': 'OTHER'}, {'name': 'Hofstra University', 'class': 'OTHER'}, {'name': 'FriendsLearn Inc.', 'class': 'UNKNOWN'}, {'name': 'The Mithra Trust', 'class': 'UNKNOWN'}, {'name': 'Mind in Motion', 'class': 'UNKNOWN'}, {'name': 'Seethapathy Clinic & Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}