Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-01-05 @ 10:26 PM
Study NCT ID:
NCT05938894
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2023-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Train Your Brain - Executive Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-03', 'size': 271599, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-11-25T10:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 630}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2023-05-07', 'studyFirstSubmitQcDate': '2023-07-10', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in response time', 'timeFrame': 'Week 0, Week 9', 'description': 'Change in online game speed of response time'}, {'measure': 'Change in percent correct', 'timeFrame': 'Week 0, Week 9', 'description': 'Change in online game percent correct'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Normal weight'], 'conditions': ['Overweight and Obesity']}, 'referencesModule': {'references': [{'pmid': '40957017', 'type': 'DERIVED', 'citation': 'Roemmich JN, Nelson AM, Stice E, Hess JM, Palmer DG, Casperson SL. Efficacy of a Web-Based Executive Function Training Program to Induce Healthier Food Choices and Increase Valuation of Fruits and Vegetables in Adults: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 16;14:e66394. doi: 10.2196/66394.'}], 'seeAlsoLinks': [{'url': 'https://trainyourbrain.usda.gov/', 'label': 'Grand Forks Human Nutrition Research Center Train Your Brain Study website'}, {'url': 'https://www.ars.usda.gov/plains-area/gfnd/gfhnrc/docs/nutrition-studies/nutrition-studies/', 'label': 'Grand Forks Human Nutrition Research Center Current Nutrition Studies'}]}, 'descriptionModule': {'briefSummary': "The purpose of this research is to test if playing games designed to improve an individual's executive function can change their views about the types of foods they eat. Executive function is a set of mental processes that people use every day to make decisions - such as what kinds of foods they choose to eat and when and where they eat those foods.", 'detailedDescription': 'The purpose of this study is to determine whether executive function (EF) training concurrently improves attitudes, perceptions, and consumption of nutrient-dense foods (i.e., fruits, vegetables) while worsening the same of nutrient-poor foods. In effect, the aim is to test whether EF training can promote the substitution of nutrient-poor foods with fruits and vegetables (FV), as the Dietary Guidelines for Americans (DGA) recommends regular consumption of FV as part of a healthy dietary pattern. Given the health benefits associated with consuming FV, EF training that effectively promotes increased FV intake may benefit health. For example, FV consumption is associated with the reduced risk of all-cause mortality, cardiovascular disease, diabetes, cancer, and eye and skin health. Moreover, FV consumption is associated with better mental and cognitive health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 23-38 kg/m2\n* US citizenship\n* Not currently dieting to lose weight and no weight loss or gain of \\>2 kg over the past 3 months\n* No tobacco or e-cigarette use\n* Not pregnant or lactating or planning to become pregnant while participating in the study\n\nExclusion Criteria:\n\n* Not a US citizen\n* Currently dieting to lose weight\n* Weight loss of \\>2 kg over the past 3 months\n* Tobacco or e-cigarette use\n* Pregnant or lactating or planning to become pregnant while participating in the study\n* A history of bariatric surgery\n* Diagnosis of major medical or psychiatric condition that would interfere with participation, including not being physically able to play the games, or a current eating disorder'}, 'identificationModule': {'nctId': 'NCT05938894', 'briefTitle': 'Train Your Brain - Executive Function', 'organization': {'class': 'FED', 'fullName': 'USDA Grand Forks Human Nutrition Research Center'}, 'officialTitle': 'The Effect of Executive Function Training on Diet and Attitudes', 'orgStudyIdInfo': {'id': 'GFHNRC299'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EFfect-food choices', 'description': 'Participants will complete four online games at least biweekly during the study.', 'interventionNames': ['Other: online games with various food images']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Participants will complete four online games at least biweekly during the study.', 'interventionNames': ['Other: online games with images of flowers and songbirds']}], 'interventions': [{'name': 'online games with various food images', 'type': 'OTHER', 'description': 'Participant will play a series of online games with various food images.', 'armGroupLabels': ['EFfect-food choices']}, {'name': 'online games with images of flowers and songbirds', 'type': 'OTHER', 'description': 'Participant will play a series of online games with images of flowers and songbirds.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58203', 'city': 'Grand Forks', 'state': 'North Dakota', 'country': 'United States', 'facility': 'USDA Grand Forks Human Nutrition Research Center', 'geoPoint': {'lat': 47.92526, 'lon': -97.03285}}], 'overallOfficials': [{'name': 'Shanon Casperson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USDA Grand Forks Human Nutrition Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USDA Grand Forks Human Nutrition Research Center', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}