Preventing Diabetes Among Patients With Pre-Diabetes by Improving Patient-Activation and Enhancing Clinical Decision Support for Weight Management to Lower Costs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Demographics
研究概览
简要总结
The purpose of this project is to improve the quality of weight management care for patients with pre-diabetes and overweight or obesity. Personalized risk profiles, clinical decision support, and patient-centered decision tools for understanding pre-diabetes risk and the likelihood of preventing diabetes with a modest 5-7% weight loss will be developed. This project will offer patients their choice of effective weight management treatment options, each containing the cornerstone of weight management- intensive lifestyle intervention. Patients and PCPs will be better informed and equipped with information that helps them make weight management treatment decisions that work the best for their lifestyle, and each is expected to produce at least 5-7% weight loss over 6 months.
详细描述
The primary aim of this study was to demonstrate that an increased recruitment rate for weight loss intervention can be achieved within patients that have pre-diabetes by communicating personalized risk of progression to type 2 diabetes, by estimating risk reduction with weight loss, and by offering program choice. Secondary aims included program participation rate, weight loss, and short term decreased diabetes risk.
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
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least two weight measures within the last two 24 months, including most recent, that meet the following criteria:
- •Prediabetes and BMI >27: Treatment Option 1, 2, 3, or 4
- •Prediabetes and BMI >40: Treatment Options 1-5
- •Most recent laboratory value that meets prediabetes indicators, per American Diabetes Association, 2016
- •Hemoglobin A1C ≥5.7% and <6.5%, or
- •Fasting plasma glucose ≥100 mg/dl and <126 mg/dl, or
- •Oral glucose tolerance test ≥140 mg/dl and <200 mg/dl
排除标准
- •History of significant weight loss documented within 5 years,
- •Contraindications to weight change (e.g., cancer, pregnancy)
- •Prior bariatric surgery
- •Weight loss medication use or orders within 5 years prior to the project.
结局指标
主要结局
Demographics
时间窗: Baseline
Race, ethnicity, education level, marital status, household income, and weight management history.
Pre-Diabetes Indicator
时间窗: 12 months
At baseline, 6 months,12 months, we will assess HbA1c from the intervention participants. These measures will provide important information about changes in participants' risk and prevention of diabetes.
Body Weight
时间窗: 12 Months
The study's primary outcome is change in body mass index (in kg) from baseline to 12-month follow-up.
Patient-Centered Outcomes
时间窗: 12 months
Treatment satisfaction and patient involvement in care survey
次要结局
未报告次要终点