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| ID | Type | Description | Link |
|---|---|---|---|
| R18DK079855 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to determine if providing free-of-charge access to a group-based lifestyle intervention delivered in partnership with the community is cost-effective for the prevention of type 2 diabetes.
Randomized controlled trials have shown that modest lifestyle changes can prevent or delay the onset of diabetes in adults with pre-diabetes. Unfortunately, despite the increasing prevalence of pre-diabetes and diabetes in all facets of the population, intervention programs needed to achieve these goals are costly and remain unavailable in most clinical settings. Over the past 3 years, we have demonstrated the feasibility of training community instructors to deliver a group-based adaptation of the Diabetes Prevention Program (DPP) lifestyle intervention. In this pilot research, this new delivery model achieves a level of weight reduction that was associated with diabetes prevention and improved cardiometabolic risk factor control in the DPP. This new, large-scale randomized effectiveness trial is designed to evaluate the costs and effectiveness of a partnered approach to identify adults with pre-diabetes in primary care settings, deliver brief advice for diabetes prevention, and provide access to a group-based adaptation of the DPP lifestyle intervention offered by the community. This study will compare costs and outcomes to a standard care, brief clinical counseling approach delivered by Registered Dietitians.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietitian Counseling Alone | Active Comparator | Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian. Registered Dietitian Counseling Alone |
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| Dietitian Plus Community Group Lifestyle | Experimental | Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian, PLUS free-of-charge access to a group-based diabetes prevention lifestyle intervention offered by the community. Dietitian Counseling Plus Community Group Lifestyle Intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietitian Counseling Alone | Behavioral | Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian |
|
| Measure | Description | Time Frame |
|---|---|---|
| % Change in Body Weight | (weight in kg at 12 months - weight in kg at baseline) / (weight in kg at baseline) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| % Change in Blood Total Cholesterol | (total blood cholesterol concentration at 12 months - total blood cholesterol concentration at baseline) / (total blood cholesterol concentration at baseline) | 12 months |
| % Change in glycosylated hemoglobin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald T Ackermann, MD, MPH | Northwestern University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
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| ID | Term |
|---|---|
| D064686 | Nutritionists |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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| Dietitian Plus Community Group Lifestyle | Behavioral | Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian, PLUS free-of-charge access to a group-based lifestyle intervention offered by the Community to prevent diabetes |
|
(HbA1c % at 12 months - HbA1c % at baseline) / (HbA1c % at baseline)
| 12 months |
| % Change in Blood Pressures | (mean SBP at 12 months - mean SBP at baseline) / (mean SBP at baseline); (mean DBP at 12 months - mean DBP at baseline) / (mean DBP at baseline) | 12 months |
| Changes in Dietary Composition | NHIS Multifactor Screener: Change in % dietary kcal from fat at 12 months (est % dietary Kcal from fat at 12 months - est % dietary Kcal from fat at baseline) | 12 months |
| Changes in Physical Activity | Paffenbarger PAQ: (Total Kcal/week energy expenditure from walking, stairs, and leisure time activity at 12 months - Total Kcal/week energy expenditure from walking, stairs, and leisure time activity at Baseline) | 12 months |
| Incremental Costs | 12 months |
| Incremental Health State Utility | 12 months |
| % Change in Body Weight | (weight in kg at 6 months - weight in kg at baseline) / (weight in kg at baseline) | 6 months |
| % Change in Body Weight | (weight in kg at 24 months - weight in kg at baseline) / (weight in kg at baseline) | 24 months |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004700 | Endocrine System Diseases |