Addressing The Role of Nutrition Education & Health Literacy in Diabetes Care

Study Overview
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Brief Summary
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This study examines the impact of certified diabetes education, and the role of different educational approaches to medical nutrition therapy. in addition the role of patient health literacy level is assessed

Detailed Description
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150 patients with type 2 diabetes with most recent a1c>7% will be enrolled. patients are randomized to three arms: arm 1 includes 3 individualized visits with an rd-cde focused on a modified plate method for nutrition therapy, arm 2 includes 3 individualized visits with an rd-cde focused on carb counting for nutrition therapy, and arm 3 focuses on general diabetes education and health promotion. education sessions will be administered over a 4-6 week period. patients will be assessed at baseline, 3 and 6 month follow-up. primary outcome is a1c.

Official Title
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Addressing The Role of Nutrition Education & Health Literacy in Diabetes Care

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Active Control
* Behavioral: int arm 1
* Behavioral: int arm 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Most recent a1c >7 Type 2 diabetes Receiving primary care Not currently in the diabetes improvement program No plans to refer to diabetes improvement program in the next 6 mos Exclusion Criteria: Significant dementia or psychosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Control<br>patients receive 3 individualized visits with a health educator for education on general diabetes and health promotion | Behavioral: Active Control<br>* patients receive 3 individualized visits with a health educator focused on general diabetes education and health promotion<br>|
| Experimental: Intervention 1<br>patients receive 3 individualized visits with an rd-cde for education focused on modified plate method | Behavioral: int arm 1<br>* VVpatients receive 3 individualized visits with an rd-cde for education focused on modified plate method<br>|
| Experimental: intervention 2<br>patients receive 3 individualized visits with an rd-cde for education focused on carb counting | Behavioral: int arm 3<br>* patients receive 3 individualized visits with an rd-cde for education focused on carb counting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A1C |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-efficacy |  | 3 and 6 months | 
| satisfaction |  | 3 and 6 months | 
| dietary behavior |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, education, health literacy