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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK132362 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Kansas State University | OTHER |
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The purpose of this randomized controlled trial is to compare the effectiveness of Cooperative Extension implementing two delivery methods (group video vs. self-directed) and participant recruitment strategies of the National Diabetes Prevention Program (NDPP) to adults in rural communities. Exploratory assessments of implementation facilitators and barriers will be completed to determine strategies that may impact intervention effectiveness and that may support or impede the implementation, dissemination, and effectiveness of Cooperative Extension to deliver the NDPP to prediabetic adults in rural areas.
This 12 mo. Type II hybrid effectiveness-implementation trial will compare effectiveness (weight loss, physical activity, HbA1c) of Cooperative Extension delivering the Diabetes Prevention Program (DPP) by group video using Zoom® (GV) vs. a self-directed (SD) control. Active vs. passive participant recruitment strategies will be compared on recruitment outcomes including time to full enrollment, participant yield, and retention rates. Ten Cooperative Extension local units/districts serving rural Kansas counties will be allocated to either active or passive recruitment. Each of the sites will recruit adults with prediabetes living in the county served by Kansas State Research and Extension site and will be randomized to one of the 2 intervention arms. A centralized team of Cooperative Extension Agents who complete NDPP lifestyle coach training will serve as interventionists for both the GV and SD arms. Primary (weight) and secondary outcomes (HbA1c, the proportion of participants meeting weight loss (≥ 5%) and physical activity goals (≥150 min./wk.) will be assessed at baseline, 6 and 12 mos. Findings will inform best practices in the delivery of the DPP through Cooperative Extension in rural communities that could reach this high risk population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Video Diabetes Prevention Program | Experimental | Participants randomized to the group video DPP for 12-months. |
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| Self Directed Diabetes Prevention Program | Active Comparator | Participants randomized to the self directed DPP for 12-months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoom Group Video (GV) | Behavioral | Zoom delivery of the DPP. Participants have access to Prevent T2 Curriculum and connected technology to track weight and physical activity. |
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| Measure | Description | Time Frame |
|---|---|---|
| Weight change across 12 months | Weight (kg) will be assessed to the nearest 0.1 kg with a calibrated scale (Belfour Inc., Model #PS6600). All participants will be weighed between the hours of 6 and 10 am following an overnight fast of at least 8 hours in a standard hospital gown. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c change across 12 months | Hemoglobin A1c will be collected and assessed by Quest Diagnostic. Participants will be required to fast for at least 12 hours before blood draw. A total of 3-5 teaspoons of blood will be collected by inserting a needle in a vein in the arm for routine laboratory tests at each clinic visit. Participant blood samples will be used to measure HbA1c. | Baseline to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annie Rice, M.S. | Contact | 785-764-3770 | arice7@kumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anna M Gorczyca, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D009043 | Motor Activity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Self Directed (SD) | Behavioral | Self directed delivery of the DPP. Participants have access to online curriculum, lifestyle coach and connected technology to track weight and physical activity. |
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| CDC-NDPP Weight Loss Goal | CDC-NDPP weight loss goal will be categorized as the percentage of participants who achieve ≥ 5% weight loss across the 12 month intervention. | Baseline to 12 months |
| CDC-NDPP Physical Activity Goal | CDC-NDPP physical activity goal will be categorized by the percentage of participants who achieve an average of ≥ 150 min./wk. of PA across the 12 month intervention. | Baseline to 12 months |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |