Impact of a Diabetes Risk Score on Lifestyle Education and Patient Adherence (IDEA Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 223
- 试验地点
- 10
- 主要终点
- Attendance rates
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Attendance rates
时间窗: 6 months
Attendance rates (percentage of subjects attending the classes) of the two groups will be compared.
Change in weight
时间窗: baseline, 12 weeks, 24 weeks
change in weight from baseline to 12 weeks and 24 weeks will be compared between groups.
Change in BMI
时间窗: 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
时间窗: baseline, 12 weeks, 24 weeks
change in abdominal circumference from baseline to 12 weeks and 24 weeks will be compared between groups.
次要结局
- 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)
研究者
Mark True, MD
Program Director, Endocrinology Fellowship
59th Medical Wing