Translating the Diabetes Prevention Project (DPP) in a Health Maintenance Organization (HMO) Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Program feasibility: Uptake
研究概览
简要总结
It is estimated that 30 million U.S. adults will have type 2 diabetes by 2050. Contributing to this national trend is the obesity epidemic. Three randomized trials have demonstrated that intensive behavioral interventions can prevent or delay the onset of diabetes. The purpose of this pilot study is to inform a future randomized, controlled Phase III trial of a population-based, telephonic, exercise and weight loss intervention to translate the findings of the Diabetes Prevention Program into practice. The telephonic intervention will be compared to usual care (30 participants in each group). The investigators will deliver the intervention in 12 weekly, 20-minute calls, with four subsequent maintenance calls, for a total of 16 calls over 24 weeks. Study outcomes will be measured at baseline and at 12 and 24 weeks.
For this planning grant the investigators do not have an overall hypothesis. The investigators' goal is to develop and test whether it is possible to do exercise and weight loss
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
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •Age 40-74
- •Receives primary care at Group Health Central, Rainier, or Poulsbo clinics in the greater Seattle area
- •Can walk for more than 10 minutes
- •Fasting plasma glucose (FPG) 105-125 mg/dl or glycolated hemoglobin (HbA1C) 5.7-6.4
- •Body Mass Index (BMI) 25 kg/m2 or greater
排除标准
- •Type 1 or 2 diabetes
- •FPG > 125 mg/dl or < 105mg/dl at screening blood draw
- •HbA1C > 6.4 or < 5.7 at screening blood draw
- •Systolic blood pressure > 210 mmHg at the baseline clinic visit
- •Exercise ≥ 30 minutes/day, at least five days a week
- •Current participation in another structured weight loss treatment program or another intervention study
- •Severe concurrent disease
- •Unavailable for the 24-week study period
- •Unable to read or speak English
- •Pregnant or planning to become pregnant.
- •Mentally or legally incapacitated such that informed consent cannot be obtained.
研究组 & 干预措施
Intervention
Participants assigned to the intervention group worked with the study interventionist over the phone to reduce their risk for developing Diabetes Mellitus, Type 2. The intervention lasted for 24 weeks, with weekly phone calls for the first 12 weeks and 4 maintenance calls over the second 12 weeks. Study measurements were taken at baseline, 12 weeks, 24 weeks, and 52 weeks. After 24 weeks, the investigators randomly divided the intervention group in half. The first group did not receive any more phone calls from the interventionist. The second group continued to receive monthly 20-minute phone calls from the interventionist. At 52 weeks post-baseline participants from both groups had their labs drawn, wore a pedometer for 3 days, and called in with a self-reported weight.
干预措施: Telephonic intervention to prevent Diabetes Mellitus, Type 2 (Behavioral)
Control
Participants randomized into this group did not receive any intervention, although they were encouraged to follow-up with their doctor and follow through with usual clinical care.
结局指标
主要结局
Program feasibility: Uptake
时间窗: Baseline
Measured by the number of people who consent to be in the study compared to the number who were eligible
Program feasibility: Attendance
时间窗: 52 weeks
Measured by the number of participants who complete their 52 week assignments (3 day pedometer, self-reported weight, fasting blood draw)
次要结局
- Fasting glucose(Baseline, 12 weeks, 24 weeks, 52 weeks)
- Waist circumference(Baseline, 12 weeks, 24 weeks)
- Blood pressure(Baseline, 12 weeks, 24 weeks)
- Healthy eating habits(Baseline, 12 weeks, 24 weeks)
- Weight loss(Baseline, 12 weeks, 24 weeks, 52 weeks)
- Changes in activity(Baseline, 12 weeks, 24 weeks, 52 weeks)
- Glycated hemoglobin (A1C)(Baseline, 12 weeks, 24 weeks, 52 weeks)
- Total cholesterol (TC)(Baseline, 12 weeks, 24 weeks, 52 weeks)
- High density lipoprotein (HDL)(Baseline, 12 weeks, 24 weeks, 52 weeks)
- Low density lipoprotein (LDL)(Baseline, 12 weeks, 24 weeks, 52 weeks)
- Body Mass Index (BMI)(Baseline, 12 weeks, 24 weeks, 52 weeks)
- Physical activity level(Baseline, 12 weeks, 24 weeks, 52 weeks)