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

Sponsor

Eastern Virginia Medical School (Other)

Overall Status

Completed

CT.gov ID

NCT00323349

Collaborator

Centers for Disease Control and Prevention (U.S. Fed), Association of Teachers of Preventive Medicine (Industry)

276

Enrollment

Locations

Duration (Months)

138

Patients Per Site

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prediabetic State	Procedure: Oral Glucose Tolerance Testing Behavioral: Education tailored to learning style preferences	N/A

Study Design

Study Type:

Interventional

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

Study Start Date :

Apr 1, 2003

Study Completion Date :

Dec 1, 2004

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.