Clinical trial NCT00323349: A Study of Attitudes About the Risk of Developing Type 2 Diabetes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetic State
Keywords: Glucose Tolerance Test
Health Knowledge, Attitudes, Practice
Motivation
Communication
Health Behavior
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Association of Teachers of Preventive Medicine
First posted: 2006-05-09
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

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.


Eligibility 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

Primary outcomes:
measure: Scores on perceived risk scale after the intervention
measure: Scores on motivation to change behavior scale after the intervention
Secondary outcomes:
measure: Scores on scales of perceived benefits of healthy lifestyle choices
measure: Scores on scales of perceived barriers to healthy lifestyle choices
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Ghent Family Practice
state: Virginia
city: Portsmouth
country: United States
facility: Portsmouth Family Medicine
state: Virginia
Study officials:
affiliation: Eastern Virginia Medical School
name: Laura E Eizember, MD
role: PRINCIPAL_INVESTIGATOR
References: