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A Study of Attitudes About the Risk of Developing Type 2 Diabetes

NCT00323349 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2007-06-28

No results posted yet for this study

Summary

Diabetes mellitus (DM) type 2 is well recognized as a major cause of morbidity and mortality in the United States, as well as a significant contributor to health disparities within the population. Changes in demographic and lifestyle characteristics in the population have led to a progressive increase in the prevalence of both diabetes and impaired glucose tolerance (IGT), a precursor to DM type 2. Although pharmacologic interventions have proven to be successful in blocking the progression from IGT to DM, they have not been as effective as diet and exercise modification. Studies of behavioral interventions in IGT have focused on the outcomes of improved DM risk factors and decreased progression to DM, but have either required extensive interventions that lack applicability to the general population or have utilized more modest interventions with no effect on risk factors. These studies have not included impact evaluations to assess the effect of knowledge of IGT status on motivation to change and perceived risk. This study will assess the impact of knowledge of IGT on the likelihood of altering health-related behaviors, utilizing the Health Belief Model as a conceptual framework. Subjects will be randomized to one of four treatment arms, organized in a factorial design to (1) assess the impact of OGTT testing on motivation to change behaviors and (2) evaluate the efficacy of a novel educational intervention linked to patients' learning styles. This evaluation will determine whether OGTT testing is more beneficial as a cue to action to motivate behavior change than a multifactorial assessment of diabetes risk. Additionally, the improvement in health motivation after an educational intervention is expected to be enhanced when the educational method is tailored to the individual's preferred learning style. This information will provide the foundation for more efficient behavioral interventions for patients at high risk for DM type 2.

Conditions

  • Prediabetic State

Interventions

PROCEDURE

Oral Glucose Tolerance Testing

BEHAVIORAL

Education tailored to learning style preferences

Sponsors & Collaborators

Principal Investigators

  • Laura E Eizember, MD · Eastern Virginia Medical School

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-04-30
Completion
2004-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00323349 on ClinicalTrials.gov