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

Overview

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

Full Title of Study: “Addressing The Role of Nutrition Education & Health Literacy in Diabetes Care”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2010

Detailed Description

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.

Interventions

  • Behavioral: Active Control
    • patients receive 3 individualized visits with a health educator focused on general diabetes education and health promotion
  • Behavioral: int arm 1
    • VVpatients receive 3 individualized visits with an rd-cde for education focused on modified plate method
  • Behavioral: int arm 3
    • patients receive 3 individualized visits with an rd-cde for education focused on carb counting

Arms, Groups and Cohorts

  • Active Comparator: Active Control
    • patients receive 3 individualized visits with a health educator for education on general diabetes and health promotion
  • Experimental: Intervention 1
    • patients receive 3 individualized visits with an rd-cde for education focused on modified plate method
  • Experimental: intervention 2
    • patients receive 3 individualized visits with an rd-cde for education focused on carb counting

Clinical Trial Outcome Measures

Primary Measures

  • A1C
    • Time Frame: 6 months

Secondary Measures

  • self-efficacy
    • Time Frame: 3 and 6 months
  • satisfaction
    • Time Frame: 3 and 6 months
  • dietary behavior
    • Time Frame: 6 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Vanderbilt University
  • Collaborator
    • American Association of Diabetes Educators
  • Provider of Information About this Clinical Study
    • Principal Investigator: Russell Rothman, Prinicipal Investigator – Vanderbilt University
  • Overall Official(s)
    • Russell Rothman, MD MPP, Principal Investigator, Vanderbilt University Medical Center

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