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| ID | Type | Description | Link |
|---|---|---|---|
| OT2HL158287 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The NIH Community Engagement Alliance | UNKNOWN |
| Oyate Health Center | UNKNOWN |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The goal of this research is to evaluate a scientifically rigorous diabetes intervention, Together Overcoming Diabetes (TOD), that has been tailored to address the unique underlying risk and protective factors and social determinants of diabetes among American Indian/Alaska Native (AI/AN) populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Together Overcoming Diabetes Intervention | Experimental | Together Overcoming Diabetes curriculum adapted for Lakota caregivers and the caregivers families |
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| Waitlist Standard of Care | Placebo Comparator | Participants who are waitlisted to receive the TOD intervention will receive Standard of Care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOD Great Plains | Behavioral | The adapted TOD intervention is rooted in the original TOD structure, delivery system, and home-visiting teaching schedule. Local enhancements include intervention topics and activities to address local adult caregivers' diabetes management and to promote families' modifiable risk and protective factors targeted by this proposal and informed by the Wicozani wellness concept and measurement. The TOD intervention includes targeted content taught approximately bi-weekly by family health coaches over a 16-week period. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated hemoglobin (HbA1c) | Glycated hemoglobin as measured by a point-of-care A1c test | Baseline, 3 months, 6 months, and 12 months |
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Inclusion Criteria - Adult Index Participants:
Exclusion Criteria - Adult Index Participants:
Inclusion Criteria - Youth Support Participants:
Exclusion Criteria - Youth Support Participants:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Courtney Claussen, PhD | Contact | 605-200-0043 | cclauss1@jh.edu |
| Name | Affiliation | Role |
|---|---|---|
| Donald Warne, MD, MPH | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Indigenous Health - Great Plains Hub | Recruiting | Rapid City | South Dakota | 57701 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Waitlist randomized control trial
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Independent Evaluators are masked to the study participants' randomized group status/
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| Waitlist Standard of Care | Behavioral | Participants who are waitlisted to receive the TOD intervention will receive Standard of Care. |
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