Impact of a Diabetes Risk Score on Lifestyle Education and Patient Adherence (IDEA Trial)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pre-diabetes
- Sponsor
- 59th Medical Wing
- Enrollment
- 223
- Locations
- 5
- Primary Endpoint
- Attendance rates
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Investigators
Mark True, MD
Program Director, Endocrinology Fellowship
59th Medical Wing
Eligibility Criteria
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
Outcomes
Primary Outcomes
Attendance rates
Time Frame: 6 months
Attendance rates (percentage of subjects attending the classes) of the two groups will be compared.
Change in weight
Time Frame: baseline, 12 weeks, 24 weeks
change in weight from baseline to 12 weeks and 24 weeks will be compared between groups.
Change in BMI
Time Frame: baseline, 12 weeks, 24 weeks
change in BMI from baseline to 12 weeks and 24 weeks will be compared between groups.
Change in abdominal circumference
Time Frame: baseline, 12 weeks, 24 weeks
change in abdominal circumference from baseline to 12 weeks and 24 weeks will be compared between groups.
Secondary Outcomes
- Change in blood pressure(baseline, 12 weeks, 24 weeks)
- Change in HgA1c(baseline, 12 weeks, 24 weeks)
- Change in fasting blood glucose(baseline, 12 weeks, 24 weeks)
- Change in cholesterol(baseline, 12 weeks, 24 weeks)
- Change in diabetes risk score(baseline, 12 weeks, and 24 weeks)