Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-25 @ 3:51 AM
Study NCT ID:
NCT02700503
Status:
COMPLETED
Last Update Posted:
2019-08-07
First Post:
2016-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Finding the Patient's Voice Diabetes Prevention Programs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D011236', 'term': 'Prediabetic State'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-05', 'studyFirstSubmitDate': '2016-02-23', 'studyFirstSubmitQcDate': '2016-03-01', 'lastUpdatePostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Subject's BMI calculation Charted on CDC Stature for Age and Weight for Age Percentiles chart", 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Hemoglobin A1C', 'timeFrame': '12 months'}, {'measure': 'Physical activity', 'timeFrame': '12 months', 'description': 'self-report'}, {'measure': 'Quality of life', 'timeFrame': '12 months', 'description': 'Pediatric Quality of Life Inventory'}, {'measure': 'Intervention group session attendance', 'timeFrame': '12 months'}, {'measure': 'Dietary records', 'timeFrame': '12 months', 'description': 'Semi-quantitative food frequency questionniare'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes prevention', 'type 2 diabetes', 'prediabetes', 'family'], 'conditions': ['Diabetes Mellitus, Type 2', 'Prediabetic State']}, 'descriptionModule': {'briefSummary': 'This study uses patient engagement to develop a diabetes prevention program focused on adolescents and families.', 'detailedDescription': 'Due to increases in obesity, the onset of type 2 diabetes is occurring at an ever-younger age, and is associated with poor outcomes and rising costs, which emphasizes the need for prevention at earlier ages. To address this need, the investigators designed the ENCOURAGE Healthy Families curriculum; a program based on the scientifically proven U.S. Diabetes Prevention Program, and while data demonstrate a reduction in obesity and diabetes risk for mothers and their children, the investigators have encountered several barriers to widespread implementation, including:\n\n1. helping youth/families understand the importance of prevention,\n2. on-going interest and participation, and\n3. differing personal beliefs.\n\nPatient-centered research is needed to better understand what adolescents/families want in prevention initiatives, who should deliver program content, where and when to deliver programs in the community, and how adolescents/families wish to be informed of results. The investigators believe that by engaging patients and the community in the development process, the investigators will be able to obtain workable answers to these questions at a population level for high-risk youth/families in "real world" settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Overweight (BMI \\>85th percentile for age and sex, weight for height \\>85th percentile, or weight \\>120% of ideal \\[50th percentile\\] for height)\n2. At least two of the following risk factors:\n\n * Have been diagnosed with prediabetes;\n * Have a family history of T2DM in first- and second-degree relatives;\n * Belong to a minority race/ethnic group (Native Americans, African-Americans, Hispanic Americans, Asians/South Pacific Islanders);\n * Have conditions associated with insulin resistance; and/or\n * Have had gestational diabetes or were exposed to gestational diabetes in utero.\n3. A family support person who is also willing to participate in the study. This person would preferably be a parent also at risk for diabetes (history of gestational diabetes, prediabetes, or with T2D).\n\nExclusion Criteria:\n\n1\\. Type 2 diagnosis'}, 'identificationModule': {'nctId': 'NCT02700503', 'briefTitle': "Finding the Patient's Voice Diabetes Prevention Programs", 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': "Finding the Patient's Voice: Development of Practical Approaches for Adolescent and Family Focused Diabetes Prevention Programs", 'orgStudyIdInfo': {'id': '1510313617'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study. It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied.', 'interventionNames': ['Behavioral: Encourage 2.0']}], 'interventions': [{'name': 'Encourage 2.0', 'type': 'BEHAVIORAL', 'description': 'Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study. It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46032', 'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': "Riley Children's Specialties", 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': "Riley Children's Hospital", 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Tamara Hannon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Indiana University Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Tamara S. Hannon', 'investigatorAffiliation': 'Indiana University'}}}}