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

NCT00323349 | Completed

• 1 other identifier: TS-0931
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 2

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.

Conditions

Prediabetic State

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Scores on perceived risk scale after the intervention

• Scores on motivation to change behavior scale after the intervention

Secondary Outcomes (2)

• Scores on scales of perceived benefits of healthy lifestyle choices

• Scores on scales of perceived barriers to healthy lifestyle choices

Interventions

Oral Glucose Tolerance Testing PROCEDURE

Education tailored to learning style preferences BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of diabetes (not gestational diabetes)
• Current laboratory results consistent with diabetes
• Current pregnancy

Sponsors & Collaborators

• Eastern Virginia Medical School: lead
• Centers for Disease Control and Prevention: collaborator
• Association of Teachers of Preventive Medicine: collaborator

Study Sites (2)

Ghent Family Practice

Norfolk, Virginia, 23507, United States

Location

Portsmouth Family Medicine

Portsmouth, Virginia, 23707, United States

Location

MeSH Terms

Conditions

Prediabetic State; Behavior; Communication; Health Behavior

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Laura E Eizember, MD

  Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 6, 2006
• First Posted: May 9, 2006
• Study Start: April 1, 2003
• Study Completion: December 1, 2004
• Last Updated: June 28, 2007

Record last verified: 2007-06

Locations

US (2)