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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2004-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prediabetic State

Keywords

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Glucose Tolerance Test Health Knowledge, Attitudes, Practice Motivation Communication Health Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

NONE

Interventions

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Oral Glucose Tolerance Testing

Intervention Type PROCEDURE

Education tailored to learning style preferences

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Laura E Eizember, MD

Role: PRINCIPAL_INVESTIGATOR

Eastern Virginia Medical School

Locations

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Ghent Family Practice

Norfolk, Virginia, United States

Site Status

Portsmouth Family Medicine

Portsmouth, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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TS-0931

Identifier Type: -

Identifier Source: org_study_id