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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK115434 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study will evaluate a behavioral intervention designed to reduce risk factors for type 2 diabetes in American Indian youth aged 7-10 years.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Living | Active Comparator | Three component behavioral intervention consisting of group-based classes, individual motivational interviewing-based sessions, and resource toolbox |
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| Health and Safety | Placebo Comparator | One component health and safety program consisting of group classes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Living | Behavioral | Participants will be provided with education and support for diet and lifestyle modification related to healthy eating and active living. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from 0 to 12 months in Body Mass Index (BMI) | 12 months | |
| Change from 0 to 12 months in fasting insulin | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from 0 to 12 months in BMI z-score | 12 months | |
| Change from 0 to 12 months in waist circumference | 12 months | |
| Change from 0 to 12 months in hemoglobin A1c |
| Measure | Description | Time Frame |
|---|---|---|
| Change from 0 to 12 months in fruit/vegetable intake | Proportion consuming 5+ servings of fruits/vegetables daily | 12 months |
| Change from 0 to 12 months in physical activity | Proportion engaging in 1+ hour of moderate-vigorous physical activity daily |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Sauder, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital Colorado | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D006262 | Health |
| D012449 | Safety |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
| D000056 | Accident Prevention |
| D000059 | Accidents |
| D011634 | Public Health |
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| Health and Safety | Other | Participants will be provided with education related to general health and safety topics. |
|
| 12 months |
| Change from 0 to 12 months in fasting glucose | 12 months |
| 12 months |
| Change from 0 to 12 months in screen time | Proportion watching 2 hours or less of screen time daily | 12 months |
| Change from 0 to 12 months in sugary beverage intake | Proportion consuming 0 servings of sugary beverages daily | 12 months |
| Participant engagement | Qualitative factors related to participant engagement | 12 months |
| Program implementation | Qualitative factors related to program implementation | 12 months |
| Potential for sustained delivery | Qualitative factors related to potential for sustained delivery | 12 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004778 |
| Environment and Public Health |