NCT00715585

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 13, 2013

Status Verified

June 1, 2013

Enrollment Period

2 years

First QC Date

July 10, 2008

Last Update Submit

June 11, 2013

Conditions

Diabetes

Keywords

diabeteseducationhealth literacy

Outcome Measures

Primary Outcomes (1)

  • A1C

    6 months

Secondary Outcomes (3)

  • self-efficacy

    3 and 6 months

  • satisfaction

    3 and 6 months

  • dietary behavior

    6 months

Study Arms (3)

Active Control

ACTIVE COMPARATOR

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

Behavioral: Active Control

Intervention 1

EXPERIMENTAL

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

Behavioral: int arm 1

intervention 2

EXPERIMENTAL

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

Behavioral: int arm 3

Interventions

Active ControlBEHAVIORAL

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

Active Control
int arm 1BEHAVIORAL

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

Intervention 1
int arm 3BEHAVIORAL

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

intervention 2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Significant dementia or psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt

Nashville, Tennessee, 37215, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Russell Rothman, MD MPP

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

July 10, 2008

First Posted

July 15, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

June 13, 2013

Record last verified: 2013-06

Locations

US(1)