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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2010 by Vanderbilt University.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

American Association of Diabetes Educators

Information provided by:

Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00715585

First received: July 10, 2008

Last updated: April 22, 2010

Last verified: April 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

July 10, 2008

Last Updated Date

April 22, 2010

Start Date ^ICMJE

June 2008

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

A1C [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00715585 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

self-efficacy [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
satisfaction [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
dietary behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Active Control
patients receive 3 individualized visits with a health educator for education on general diabetes and health promotion

Intervention: Behavioral: Active Control
Experimental: Intervention 1
patients receive 3 individualized visits with an rd-cde for education focused on modified plate method

Intervention: Behavioral: int arm 1
Experimental: intervention 2
patients receive 3 individualized visits with an rd-cde for education focused on carb counting

Intervention: Behavioral: int arm 3

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

June 2010

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00715585

Other Study ID Numbers ^ICMJE

08335

Has Data Monitoring Committee

Yes

Responsible Party

Russell Rothman MD MPP, Vanderbilt University

Study Sponsor ^ICMJE

Vanderbilt University

Collaborators ^ICMJE

American Association of Diabetes Educators

Investigators ^ICMJE

Principal Investigator:

Russell Rothman, MD MPP

Vanderbilt University

Information Provided By

Vanderbilt University

Verification Date

April 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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