Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT02290912
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2014-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gray Matters Alzheimer's Disease Prevention Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-02', 'studyFirstSubmitDate': '2014-11-06', 'studyFirstSubmitQcDate': '2014-11-10', 'lastUpdatePostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Picture Vocabulary', 'timeFrame': 'up to 7 months', 'description': 'Picture Vocabulary cognitive test score'}, {'measure': 'Flanker Inhibitory Control and Attention Test', 'timeFrame': 'up to 7 months', 'description': 'Flanker Inhibitory Control and Attention Test cognitive test score'}, {'measure': 'List Sorting Working Memory Test', 'timeFrame': 'up to 7 months', 'description': 'List Sorting Working Memory Test cognitive test score'}, {'measure': 'Oral Symbol Digit Test', 'timeFrame': 'up to 7 months', 'description': 'Oral Symbol Digit Test cognitive test score'}, {'measure': 'Montreal Cognitive Assessment', 'timeFrame': 'up to 7 months', 'description': 'Montreal Cognitive Assessment test score'}, {'measure': 'Rey Auditory Verbal Learning Test', 'timeFrame': 'up to 7 months', 'description': 'Rey Auditory Verbal Learning Test score'}, {'measure': 'Controlled Oral Word Association Test', 'timeFrame': 'up to 7 months', 'description': 'Controlled Oral Word Association Test score'}, {'measure': 'Blood pressure', 'timeFrame': 'up to 7 months', 'description': 'Systolic and diastolic blood pressure'}, {'measure': 'Body mass index', 'timeFrame': 'up to 7 months', 'description': 'Height and weight measurement for computing body mass index'}, {'measure': 'Insulin', 'timeFrame': 'up to 7 months', 'description': 'insulin from venipuncture blood sample'}, {'measure': 'Systemic inflammation', 'timeFrame': 'up to 7 months', 'description': 'C-reactive protein from venipuncture blood sample'}, {'measure': 'Skin carotenoid status', 'timeFrame': 'up to 7 months', 'description': 'Biophotonic device that shines a light-emitting diode (LED) light at a site on the palm, to measure the skin carotenoid level in units of Raman counts'}, {'measure': 'Triglycerides', 'timeFrame': 'up to 7 months', 'description': 'triglycerides from venipuncture blood sample'}, {'measure': 'HDL Cholesterol', 'timeFrame': 'up to 7 months', 'description': 'High-density lipoprotein from venipuncture blood sample'}, {'measure': 'LDL Cholesterol', 'timeFrame': 'up to 7 months', 'description': 'Low-density lipoprotein from venipuncture blood sample'}, {'measure': 'Total cholesterol', 'timeFrame': 'up to 7 months', 'description': 'Total cholesterol from venipuncture blood sample'}], 'secondaryOutcomes': [{'measure': 'Depression', 'timeFrame': 'up to 7 months', 'description': 'Center for Epidemiologic Studies - Depression scale score'}, {'measure': 'Motivation', 'timeFrame': 'up to 7 months', 'description': 'Situational Motivation Scale score'}, {'measure': 'Sleep Quality', 'timeFrame': 'up to 7 months', 'description': 'Pittsburgh Sleep Quality Index scale score'}, {'measure': 'Stress', 'timeFrame': 'up to 7 months', 'description': 'Perceived Stress Scale score'}, {'measure': 'Emotional Support', 'timeFrame': 'up to 7 months', 'description': 'Emotional Support subscale from the NIH Toolbox measures for social engagement'}, {'measure': 'Friendship', 'timeFrame': 'up to 7 months', 'description': 'Friendship subscale from the NIH Toolbox measures for social engagement'}, {'measure': 'Hostility', 'timeFrame': 'up to 7 months', 'description': 'Hostility subscale from the NIH Toolbox measures for social engagement'}, {'measure': 'Loneliness', 'timeFrame': 'up to 7 months', 'description': 'Loneliness subscale from the NIH Toolbox measures for social engagement'}, {'measure': 'Physical Activity - Moderate', 'timeFrame': 'up to 7 months', 'description': 'self-report question concerning # minutes per day doing moderate intensity physical activity (per Center for Disease Control definition)'}, {'measure': 'Physical Activity - Vigorous', 'timeFrame': 'up to 7 months', 'description': 'self-report question concerning # minutes per day doing vigorous intensity physical activity (per Center for Disease Control definition)'}, {'measure': 'Nutrition', 'timeFrame': 'up to 7 months', 'description': 'Diet History Questionnaire'}, {'measure': 'Readiness for Change', 'timeFrame': 'up to 7 months', 'description': 'Revised University of Rhode Island Change Assessment (R-URICA) readiness for change scale'}, {'measure': 'Metacognition', 'timeFrame': 'up to 7 months', 'description': 'Total score from a set of seven items (1=much worse to 5=much better), comparing current memory to how it was three years ago, adapted from a questionnaire of functional ability'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Alzheimer's disease prevention lifestyle intervention"], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '27485822', 'type': 'DERIVED', 'citation': 'Hartin PJ, Nugent CD, McClean SI, Cleland I, Tschanz JT, Clark CJ, Norton MC. The Empowering Role of Mobile Apps in Behavior Change Interventions: The Gray Matters Randomized Controlled Trial. JMIR Mhealth Uhealth. 2016 Aug 2;4(3):e93. doi: 10.2196/mhealth.4878.'}]}, 'descriptionModule': {'briefSummary': "This is a randomized controlled trial to develop and test the efficacy of a multi-domain lifestyle behavioral intervention designed to promote healthier lifestyle behaviors linked to lower Alzheimer's disease risk among persons aged 40 to 64 years.", 'detailedDescription': "This is a randomized controlled trial to develop and test the efficacy of a multi-domain lifestyle behavioral intervention designed to promote healthier lifestyle behaviors linked to lower Alzheimer's disease risk among persons aged 40 to 64 years. Participants are randomized to treatment or control condition. The intervention, spanning a six month period, is an evidence-based health education program."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\n* Residing or working in Cache County Utah\n* Possessing smart phone or tablet\n\nExclusion Criteria:\n\n* Dementia\n* Pregnancy\n* Untreated chronic major depression or other psychiatric condition\n* Body mass index \\> 41\n* Heart or stroke in prior 6 weeks\n* Active cancer treatment\n* Unwillingness to seek medical help when serious condition identified at intake'}, 'identificationModule': {'nctId': 'NCT02290912', 'briefTitle': "Gray Matters Alzheimer's Disease Prevention Intervention", 'organization': {'class': 'OTHER', 'fullName': 'Utah State University'}, 'officialTitle': "Gray Matters: Multi-domain Lifestyle Behavioral Alzheimer's Disease Prevention Randomized Controlled Trial", 'orgStudyIdInfo': {'id': '5606'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Health education program; informational website, experiential classes in various help domains, custom smart phone application, and wearable technology', 'interventionNames': ['Behavioral: Health education program']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention'}], 'interventions': [{'name': 'Health education program', 'type': 'BEHAVIORAL', 'description': 'The intervention is a health education program including: informational website, experiential classes, custom smart phone or smart table application, wearable activity monitor, and informal coaching by student researchers to provide moral support for lifestyle behavioral change goals. Participants are not placed on any specific behavioral regimen but instead are encouraged to adopt healthier lifestyle behaviors per the evidence-based health education program, and to attend the experiential classes "cafeteria style" (i.e. based on their individual preferences).', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Maria C Norton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Utah State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Utah State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Maria C Norton, PhD', 'investigatorAffiliation': 'Utah State University'}}}}