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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00323349
First Posted: May 9, 2006
Last Update Posted: June 28, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Centers for Disease Control and Prevention
Association of Teachers of Preventive Medicine
Information provided by:
Eastern Virginia Medical School
  Purpose
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
Prediabetic State Procedure: Oral Glucose Tolerance Testing Behavioral: Education tailored to learning style preferences

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
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

Resource links provided by NLM:


Further study details as provided by Eastern Virginia Medical School:

Primary Outcome Measures:
  • Scores on perceived risk scale after the intervention
  • Scores on motivation to change behavior scale after the intervention

Secondary Outcome Measures:
  • Scores on scales of perceived benefits of healthy lifestyle choices
  • Scores on scales of perceived barriers to healthy lifestyle choices

Estimated Enrollment: 276
Study Start Date: April 2003
Estimated Study Completion Date: December 2004
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Increased risk for diabetes type 2 by one of the following characteristics: (1) BMI>30, (2) Age>45, (3) First-degree relative with type 2 diabetes, (4) History of gestational diabetes, (5) Prior elevated fasting glucose in the previous year.

Exclusion Criteria:

  • History of diabetes (not gestational diabetes)
  • Current laboratory results consistent with diabetes
  • Current pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323349


Locations
United States, Virginia
Ghent Family Practice
Norfolk, Virginia, United States, 23507
Portsmouth Family Medicine
Portsmouth, Virginia, United States, 23707
Sponsors and Collaborators
Eastern Virginia Medical School
Centers for Disease Control and Prevention
Association of Teachers of Preventive Medicine
Investigators
Principal Investigator: Laura E Eizember, MD Eastern Virginia Medical School
  More Information

ClinicalTrials.gov Identifier: NCT00323349     History of Changes
Other Study ID Numbers: TS-0931
First Submitted: May 6, 2006
First Posted: May 9, 2006
Last Update Posted: June 28, 2007
Last Verified: June 2007

Keywords provided by Eastern Virginia Medical School:
Glucose Tolerance Test
Health Knowledge, Attitudes, Practice
Motivation
Communication
Health Behavior

Additional relevant MeSH terms:
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases