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

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Behavioral: Active Control; Behavioral: int arm 1; Behavioral: int arm 3

• Registration Number: NCT00715585
• Lead Sponsor: Vanderbilt University

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 Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-10
• Study First Submitted QC: 2008-07-14
• Study First Posted: 2008-07-15
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-11
• Last Update Posted: 2013-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
A1C	6 months

Secondary Outcome Measures

Name	Time	Method
self-efficacy	3 and 6 months
satisfaction	3 and 6 months
dietary behavior	6 months

Trial Locations

Locations (1)

Vanderbilt; 🇺🇸 Nashville, Tennessee, United States