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

Prediabetic State Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00323349
• Other study ID #: TS-0931
• Status: Completed
• Phase: N/A
• First received: May 6, 2006
• Last updated: June 27, 2007
• Start date: April 2003
• Est. completion date: December 2004

Study information

• Verified date: June 2007
• Source: Eastern Virginia Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Prediabetic State

Intervention

Procedure:
• Oral Glucose Tolerance Testing

Behavioral:
• Education tailored to learning style preferences

Locations

Country	Name	City	State
United States	Ghent Family Practice	Norfolk	Virginia
United States	Portsmouth Family Medicine	Portsmouth	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Eastern Virginia Medical School	Association of Teachers of Preventive Medicine, Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores on perceived risk scale after the intervention
Primary	Scores on motivation to change behavior scale after the intervention
Secondary	Scores on scales of perceived benefits of healthy lifestyle choices
Secondary	Scores on scales of perceived barriers to healthy lifestyle choices