Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:09 PM
Study NCT ID:
NCT03573856
Status:
UNKNOWN
Last Update Posted:
2022-11-21
First Post:
2018-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reducing Diabetes Risk Factors in American Indian Children: Tribal Turning Point
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006262', 'term': 'Health'}, {'id': 'D012449', 'term': 'Safety'}], 'ancestors': [{'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D000056', 'term': 'Accident Prevention'}, {'id': 'D000059', 'term': 'Accidents'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-17', 'studyFirstSubmitDate': '2018-05-21', 'studyFirstSubmitQcDate': '2018-06-19', 'lastUpdatePostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from 0 to 12 months in fruit/vegetable intake', 'timeFrame': '12 months', 'description': 'Proportion consuming 5+ servings of fruits/vegetables daily'}, {'measure': 'Change from 0 to 12 months in physical activity', 'timeFrame': '12 months', 'description': 'Proportion engaging in 1+ hour of moderate-vigorous physical activity daily'}, {'measure': 'Change from 0 to 12 months in screen time', 'timeFrame': '12 months', 'description': 'Proportion watching 2 hours or less of screen time daily'}, {'measure': 'Change from 0 to 12 months in sugary beverage intake', 'timeFrame': '12 months', 'description': 'Proportion consuming 0 servings of sugary beverages daily'}, {'measure': 'Participant engagement', 'timeFrame': '12 months', 'description': 'Qualitative factors related to participant engagement'}, {'measure': 'Program implementation', 'timeFrame': '12 months', 'description': 'Qualitative factors related to program implementation'}, {'measure': 'Potential for sustained delivery', 'timeFrame': '12 months', 'description': 'Qualitative factors related to potential for sustained delivery'}], 'primaryOutcomes': [{'measure': 'Change from 0 to 12 months in Body Mass Index (BMI)', 'timeFrame': '12 months'}, {'measure': 'Change from 0 to 12 months in fasting insulin', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Change from 0 to 12 months in BMI z-score', 'timeFrame': '12 months'}, {'measure': 'Change from 0 to 12 months in waist circumference', 'timeFrame': '12 months'}, {'measure': 'Change from 0 to 12 months in hemoglobin A1c', 'timeFrame': '12 months'}, {'measure': 'Change from 0 to 12 months in fasting glucose', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight/Obesity']}, 'descriptionModule': {'briefSummary': 'This study will evaluate a behavioral intervention designed to reduce risk factors for type 2 diabetes in American Indian youth aged 7-10 years.', 'detailedDescription': 'The objectives of tis study are to rigorously evaluate the effect of Tribal Turning Point (TTP) on diabetes risk factors in Native youth. The investigators will enroll up to 360 youth who are aged 7-10 years, overweight/obese (BMI \\>85th percentile), self-identify as American Indian, and have \\>1 parent/primary caregiver willing to actively participate in the program. Within each community, youth will be randomized to the TTP program or a general health and safety control program. The multi-component TTP intervention is a youth-centered adaptation of the Diabetes Prevention Program designed to reduce diabetes risk factors by improving activity and dietary behaviors. Informed by the pediatric weight management literature, the 12-month intervention includes 12 active learning group classes, 7 individual youth/parent motivational interviewing counseling sessions, and community-specific resource toolboxes. In this trial, the investigators will assess the effect of TTP on anthropometric, metabolic, and behavioral risk factors for type 2 diabetes at the end of the intervention (12mo) and after 1 year of follow-up (24mo).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* self-identify as American Indian\n* BMI \\>=85th percentile for age and sex\n* have at least one parent/primary caregiver (parent) willing to actively participate\n\nExclusion Criteria:\n\n* diabetes\n* any serious youth/parent health concerns that would interfere with participation\n* plans to move out of the area during the study period'}, 'identificationModule': {'nctId': 'NCT03573856', 'acronym': 'TTP', 'briefTitle': 'Reducing Diabetes Risk Factors in American Indian Children: Tribal Turning Point', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Reducing Diabetes Risk Factors in American Indian Children: Tribal Turning Point', 'orgStudyIdInfo': {'id': '17-1306'}, 'secondaryIdInfos': [{'id': 'R01DK115434', 'link': 'https://reporter.nih.gov/quickSearch/R01DK115434', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Living', 'description': 'Three component behavioral intervention consisting of group-based classes, individual motivational interviewing-based sessions, and resource toolbox', 'interventionNames': ['Behavioral: Active Living']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Health and Safety', 'description': 'One component health and safety program consisting of group classes', 'interventionNames': ['Other: Health and Safety']}], 'interventions': [{'name': 'Active Living', 'type': 'BEHAVIORAL', 'description': 'Participants will be provided with education and support for diet and lifestyle modification related to healthy eating and active living.', 'armGroupLabels': ['Active Living']}, {'name': 'Health and Safety', 'type': 'OTHER', 'description': 'Participants will be provided with education related to general health and safety topics.', 'armGroupLabels': ['Health and Safety']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Childrens Hospital Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Katherine Sauder, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}