Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-02-19 @ 5:50 PM
Study NCT ID:
NCT02535169
Status:
COMPLETED
Last Update Posted:
2022-08-05
First Post:
2015-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lifestyle-Related Health Outcomes in Prediabetes and Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-03', 'studyFirstSubmitDate': '2015-08-24', 'studyFirstSubmitQcDate': '2015-08-26', 'lastUpdatePostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the oral disposition index measured by oral glucose tolerance test', 'timeFrame': '6 months', 'description': 'oral disposition index = insulinogenic index x 1/fasting insulin'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['at risk for type 2 diabetes', 'currently has type 2 diabetes'], 'conditions': ['Obesity', 'Prediabetic State', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '27135792', 'type': 'DERIVED', 'citation': 'Wagner KA, Armah SM, Smith LG, Pike J, Tu W, Campbell WW, Boushey CJ, Hannon TS, Gletsu-Miller N. Associations between Diet Behaviors and Measures of Glycemia, in Clinical Setting, in Obese Adolescents. Child Obes. 2016 Oct;12(5):341-7. doi: 10.1089/chi.2015.0232. Epub 2016 May 2.'}]}, 'descriptionModule': {'briefSummary': 'This study looks as how a health education intervention strategy effects health outcomes in overweight and obese adolescents.', 'detailedDescription': 'This study aims to do the following:\n\n1. To evaluate whether a health education and coaching strategy in overweight and obese adolescents (≥85th percentile) with high risk for type 2 diabetes is superior to usual care (single nutrition consultation) for weight management, clinical health outcomes (measures of glucose tolerance), lifestyle behavior outcomes (diet and physical activity) and outcomes of importance to patients such as satisfaction with the health care team, treatment goals, and psychosocial functioning.\n2. To evaluate whether a health education and coaching strategy in obese adolescents with diabetes (type 1 or type 2) is superior to usual care (single nutrition consultation) for weight management, clinical health outcomes (measures of diabetes control), lifestyle behavior outcomes (diet and physical activity) and outcomes of importance to patients such as satisfaction with the health care team, treatment goals, and psychosocial functioning.\n3. At baseline, before the interventions described in Aims 1 and 2, to identify key diet and physical activity factors, patient characteristics, or biomarkers which are predictive of diabetes risk.\n4. At baseline, before the interventions described in Aims 1 and 2, can associations between glycemia, cardiometabolic risk factors, and diet and physical activity behaviors in overweight and obese adolescents who are at risk for type 2 diabetes be identified using the Bright Futures questionnaire, a survey for lifestyle behavior which is normally used in the clinic setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. male and female adolescents/young adults,\n2. age 10-21,\n3. Tanner stage II-V,\n4. overweight or obese (body mass index ≥85th percentile for age and sex).\n\nExclusion Criteria:\n\n1. pregnancy,\n2. use of medications that adversely affect glucose metabolism (such as glucocorticoid-containing medications or atypical antipsychotics), and\n3. syndromic obesity (such as Prader Willi, hypothalamic obesity, or Laurence- Moon-Biedl).'}, 'identificationModule': {'nctId': 'NCT02535169', 'briefTitle': 'Lifestyle-Related Health Outcomes in Prediabetes and Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Lifestyle-Related Health Outcomes in Prediabetes and Diabetes', 'orgStudyIdInfo': {'id': '1403986016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Health Education and Coaching', 'description': '1\\. To evaluate whether a health education and coaching strategy in overweight and obese adolescents (≥85th percentile) with high risk for type 2 diabetes is superior to usual care (single nutrition consultation) for weight management, clinical health outcomes (measures of glucose tolerance), lifestyle behavior outcomes (diet and physical activity) and outcomes of importance to patients such as satisfaction with the health care team, treatment goals, and psychosocial functioning.', 'interventionNames': ['Behavioral: Health Education and Coaching Strategy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Usual Care', 'description': '1\\. Dietary consult only', 'interventionNames': ['Behavioral: Dietary consult']}], 'interventions': [{'name': 'Health Education and Coaching Strategy', 'type': 'BEHAVIORAL', 'description': 'Utilizing health education and health coaching to intervene with adolescents who are at high risk for type 2 diabetes or prediabetes regarding nutrition and physical activity. A 16-week curriculum will be utilized and phone-based coaching visits will be performed.', 'armGroupLabels': ['Health Education and Coaching']}, {'name': 'Dietary consult', 'type': 'BEHAVIORAL', 'description': 'A routine clinic-based dietary consult will be performed (approximately 1-hour).', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Tamara Hannon, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will be shared via presentations and publications.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Purdue University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Nana Gletsu Miller', 'investigatorAffiliation': 'Indiana University'}}}}