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

June 11, 2013 updated by: Russell Rothman, Vanderbilt University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Vanderbilt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A1C
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

American Association of Diabetes Educators

Investigators

  • Principal Investigator: Russell Rothman, MD MPP, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

July 10, 2008

First Submitted That Met QC Criteria

July 14, 2008

First Posted (Estimate)

July 15, 2008

Study Record Updates

Last Update Posted (Estimate)

June 13, 2013

Last Update Submitted That Met QC Criteria

June 11, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08335

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Clinical Trials on Active Control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe