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Sponsors and Collaborators: |
Eastern Virginia Medical School Centers for Disease Control and Prevention Association of Teachers of Preventive Medicine |
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Information provided by: | Eastern Virginia Medical School |
ClinicalTrials.gov Identifier: | NCT00323349 |
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.
Condition | Intervention |
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Prediabetic State |
Procedure: Oral Glucose Tolerance Testing Behavioral: Education tailored to learning style preferences |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
Official Title: | Cues to Action in Diabetes Risk Education (CADRE): Randomized Study Assessing the Impact of Knowledge of Impaired Glucose Tolerance on Perceived Risk and Behavior Change Motivation |
Estimated Enrollment: | 276 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | December 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Virginia | |
Ghent Family Practice | |
Norfolk, Virginia, United States, 23507 | |
Portsmouth Family Medicine | |
Portsmouth, Virginia, United States, 23707 |
Principal Investigator: | Laura E Eizember, MD | Eastern Virginia Medical School |
Study ID Numbers: | TS-0931 |
Study First Received: | May 6, 2006 |
Last Updated: | June 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00323349 |
Health Authority: | United States: Institutional Review Board |
Glucose Tolerance Test Health Knowledge, Attitudes, Practice Motivation Communication Health Behavior |
Metabolic Diseases Glucose Intolerance Diabetes Mellitus, Type 2 Prediabetic State Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |