Impact of a Diabetes Risk Score on Lifestyle Education and Patient Adherence (IDEA)

Impact of a Diabetes Risk Score on Lifestyle Education and Patient Adherence (IDEA Trial)

The purpose of this randomized, controlled study is to evaluate whether the knowledge of a personalized diabetes risk score affects adherence to a 12-week diet and exercise lifestyle change program in prediabetic patients. The intervention group will receive diabetes risk score results at the beginning of the twelve weeks, and the control group will not receive these results. Both groups will review their baseline and 12-week diabetes risk score results at the conclusion of the program and will be followed for an additional twelve weeks. Attendance rates and changes in weight, BMI, abdominal circumference, blood pressure, HgA1c, fasting blood glucose, cholesterol, and diabetes risk score will be compared between the groups.

Study Overview

• Status: Completed
• Conditions: Motivation; Pre-diabetes; Diabetes Risk Score
• Intervention / Treatment: Other: diabetic risk score

• Study Type: Interventional
• Enrollment (Actual): 223
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Travis AFB, California, United States, 94535
      • David Grant Medical Center
  • Maryland
    • Andrews AFB, Maryland, United States, 20762
      • Andrews Military Medical Center
  • Nevada
    • Nellis AFB, Nevada, United States, 89191
      • Nellis Family Medicine
  • Ohio
    • Wright Patterson AFB, Ohio, United States, 45324
      • Wright Patterson Medical Center
  • Texas
    • Lackland AFB, Texas, United States, 78236
      • Wilford Hall Ambulatory Surgical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women of all ethnic groups
• ≥30 -75 years of age
• Pre-diabetic defined as follows: fasting plasma glucose (FPG) 100-125mg/dL, HbA1c 5.7% to 6.4%.
• Body Mass Index ≥ 25 kg/m2
• Tricare beneficiary

Exclusion Criteria:

Diagnosis of type 1 or type 2 diabetes mellitus (defined as FPG ≥126 mg/dl on two different occasions or random blood sugar ≥200) If fasting glucose >= 126 only once, a second lab does not need to be arranged in an attempt to diagnose diabetes. It is acceptable for the patient to proceed in the trial. Also, Tethys lab results (e.g., fasting glucose and A1C) should not be used to make decisions about including or excluding patients in the trial. Only Air Force lab results should be used to make this determination.

• Active duty military members
• Patients with untreated hypothyroidism or previously diagnosed Cushing's syndrome
• Subjects previously treated with metformin or thiazolidinediones in the previous 12 months
• Psychological or physical disabilities deemed likely to interfere with participation in the study
• Patients currently using weight-loss medications or medications known to affect body weight (i.e. chronic corticosteroid use)
• Major medical conditions that prevent participation in the Group Lifestyle Balance Prevention Program (i.e. severe cardiovascular or cerebrovascular disease, severe renal or liver dysfunction, etc.)
• Concurrent participation in a different weight loss program
• Previous bariatric surgery
• Unwilling to agree with the study assignments or provide informed consent
• Participation in any other research project that would interfere with this protocol
• Unable to read and write English
• Pregnant or nursing patients
• Female patients unwilling to undergo a pregnancy test or report possible pregnancy promptly and unwilling to take precautions to avoid pregnancy if potentially fertile during the study course

Discontinuation Criteria:

• Consent is withdrawn
• Death occurs
• A woman becomes pregnant
• Severe impairment of manual dexterity, vision, or intellectual function
• They become lost to follow-up because of a move or transfer outside of the geographic area

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control - diabetes risk score; the participants in the control group did not receive their diabetes risk score at the beginning of the trial, but did receive their scores to include baseline at the 12 and 24 week points.	Other: diabetic risk score
EXPERIMENTAL: Intervention - diabetes risk score; the subjects in the intervention arm received their diabetes risk scores at the beginning of the trial, 12 weeks and 24 weeks.	Other: diabetic risk score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance rates	Attendance rates (percentage of subjects attending the classes) of the two groups will be compared.	6 months
Change in weight	change in weight from baseline to 12 weeks and 24 weeks will be compared between groups.	baseline, 12 weeks, 24 weeks
Change in BMI	change in BMI from baseline to 12 weeks and 24 weeks will be compared between groups.	baseline, 12 weeks, 24 weeks
Change in abdominal circumference	change in abdominal circumference from baseline to 12 weeks and 24 weeks will be compared between groups.	baseline, 12 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure	change in blood pressure from baseline to 12 weeks and 24 weeks will be compared between groups.	baseline, 12 weeks, 24 weeks
Change in HgA1c	change in HgA1c from baseline to 12 weeks and 24 weeks will be compared between groups.	baseline, 12 weeks, 24 weeks
Change in fasting blood glucose	change in fasting blood glucose from baseline to 12 weeks and 24 weeks will be compared between groups.	baseline, 12 weeks, 24 weeks
Change in cholesterol	change in cholesterol from baseline to 12 weeks and 24 weeks will be compared between groups.	baseline, 12 weeks, 24 weeks
Change in diabetes risk score	change in diabetes risk score from baseline to 12 weeks and 24 weeks will be compared between groups.	baseline, 12 weeks, and 24 weeks

Collaborators and Investigators

• Sponsor: 59th Medical Wing
• Investigators: Principal Investigator: Mark W True, MD, US Air Force

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: August 21, 2013
• First Submitted That Met QC Criteria: August 27, 2013
• First Posted (ESTIMATE): August 30, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 30, 2013
• Last Update Submitted That Met QC Criteria: August 27, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Military; motivation; pre-diabetes; Lifestyle change; Air Force; diabetes risk score
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: IDEA Trial