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

NCT ID: NCT00715585

Last Updated: 2013-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-06-30

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.

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active Control

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

Group Type ACTIVE_COMPARATOR

Active Control

Intervention Type BEHAVIORAL

patients receive 3 individualized visits with a health educator focused on general diabetes education and health promotion

Intervention 1

patients receive 3 individualized visits with an rd-cde for education focused on modified plate method

Group Type EXPERIMENTAL

int arm 1

Intervention Type BEHAVIORAL

VVpatients receive 3 individualized visits with an rd-cde for education focused on modified plate method

intervention 2

patients receive 3 individualized visits with an rd-cde for education focused on carb counting

Group Type EXPERIMENTAL

int arm 3

Intervention Type BEHAVIORAL

patients receive 3 individualized visits with an rd-cde for education focused on carb counting

Interventions

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Active Control

patients receive 3 individualized visits with a health educator focused on general diabetes education and health promotion

Intervention Type BEHAVIORAL

int arm 1

VVpatients receive 3 individualized visits with an rd-cde for education focused on modified plate method

Intervention Type BEHAVIORAL

int arm 3

patients receive 3 individualized visits with an rd-cde for education focused on carb counting

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Association of Diabetes Educators

OTHER

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Russell Rothman

Prinicipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Russell Rothman, MD MPP

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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08335

Identifier Type: -

Identifier Source: org_study_id

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