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| Name | Class |
|---|---|
| The JPB Foundation | UNKNOWN |
| The YMCA of Greater Indianapolis | UNKNOWN |
| Regenstrief Institute, Inc. | OTHER |
| Indiana Clinical and Translational Sciences Institute |
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This study is a randomized intervention that will test two different approaches reflecting diverse levels of both intensity and cost, to achieving risk reduction of T2D. This will help address a critical question in the translation of primary prevention research into the public health: how much intensity (and thus cost) is required to achieve an effective outcome? In addition, the proposed study will address a critical need in diabetes prevention that has not received sufficient scholarly attention: the prevention of T2D in children. No studies of diabetes prevention similar in scope to the DPP have been performed in school-aged children; however, reducing childhood obesity is widely accepted as the primary pathway to decreasing the growing prevalence of T2D in the pediatric population.
The proposed interventions will target mothers with a history of Gestational Diabetes (GDM), who gave birth to babies 9 pounds or greater, or who have prediabetes who are thus at very high risk for developing diabetes, and by virtue of their GDM/prediabetes, their children are also at high risk. Because of the genetic components involved, all children born by a woman afflicted with gestational diabetes mellitus or prediabetes have elevated risk of developing Type 2 Diabetes. This first intervention builds upon the evidence-based curriculum used in the DPP and incorporates into the curriculum detailed education regarding ways to help their children adopt healthier lifestyle behaviors. It will be delivered in groups of mothers only at community sites using trained laypeople. The second intervention will use the same parent curriculum, but adds a group program for children that teach them (directly) strategies for eating better and increasing physical activity. This program will be delivered to both mothers and children in separate groups. The group sessions will take place at the same time and in the same location by a trained facilitator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle counseling mom only | Experimental | This intervention, delivered to groups of mothers only, builds upon the evidence-based curriculum used in the Diabetes Prevention Program (DPP) and incorporates into the curriculum detailed education regarding ways to help their children adopt healthier lifestyle behaviors. |
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| Lifestyle counseling mom and child | Experimental | The second intervention is delivered to both mothers and children in separate groups using the same parent Diabetes Prevention Program (DPP) curriculum, but adds a group program for children that directly teach these children strategies for eating better and increasing physical activity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Prevention Program (DPP) | Behavioral | Diabetes Prevention Program (DPP): This is an evidence-based curriculum that has shown that it is possible to prevent or delay Type 2 Diabetes (T2D) in individuals if they keep a healthy weight, eat a nutritious diet, and stay physically active. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in weight | Weight taken during data collection visits | 3, 6, and 12 months after the beginning of the assigned intervention program |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in diet | Assessed by the Food Frequency Questionnaire (FFQ) | 3, 6, and 12 months after the beginning of the assigned intervention program |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David G Marrero, PhD. | Inidana University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32770443 | Derived | Palmer KNB, Garr Barry VE, Marrero DG, McKinney BM, Graves AN, Winters CK, Hannon TS. Intervention Delivery Matters: What Mothers at High Risk for Type 2 Diabetes Want in a Diabetes Prevention Program-Results from a Comparative Effectiveness Trial. Diabetes Ther. 2020 Oct;11(10):2411-2418. doi: 10.1007/s13300-020-00891-1. Epub 2020 Aug 8. | |
| 25457793 |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| OTHER |
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| Hannon TS, Carroll AE, Palmer KN, Saha C, Childers WK, Marrero DG. Rationale and design of a comparative effectiveness trial to prevent type 2 diabetes in mothers and children: the ENCOURAGE healthy families study. Contemp Clin Trials. 2015 Jan;40:105-11. doi: 10.1016/j.cct.2014.11.016. Epub 2014 Nov 29. |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006943 | Hyperglycemia |