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Completed

NCT Number: NCT00715585

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

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

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt

Nashville, Tennessee, 37215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Control

Behavioral

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

int arm 1

Behavioral

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

int arm 3

Behavioral

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

Primary outcomes

  1. A1C

    Time frame: 6 months

Secondary outcomes

  1. self-efficacy

    Time frame: 3 and 6 months

  2. satisfaction

    Time frame: 3 and 6 months

  3. dietary behavior

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • American Association of Diabetes Educators

Registry information

Acronym: DiNES

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 15, 2008
Registry last updated
Jun 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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