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

Diabetes Clinical Trial

— DiNES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715585
• Other study ID #: 08335
• Status: Completed
• Phase: N/A
• First received: July 10, 2008
• Last updated: June 11, 2013
• Start date: June 2008
• Est. completion date: June 2010

Study information

• Verified date: June 2013
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	American Association of Diabetes Educators

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A1C		6 months	No
Secondary	self-efficacy		3 and 6 months	No
Secondary	satisfaction		3 and 6 months	No
Secondary	dietary behavior		6 months	No