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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pre-diabetes, Diabetes Risk Score, Motivation

Intervention / Treatment
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* Other: diabetic risk score


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control - diabetes risk score<br>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<br> <br> |
| Experimental: Intervention - diabetes risk score<br>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<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pre-diabetes, diabetes risk score, motivation, Air Force, Military, Lifestyle change