Promoting Successful Weight Loss in Primary Care in Louisiana Using Information Technology
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 352
- 试验地点
- 2
- 主要终点
- Body weight (Percent Change)
研究概览
简要总结
The primary aim is to test the effectiveness of an innovative 24-month pragmatic and scalable weight-loss centric approach using a collaborative care model that connects patients with a non-Primary Care Practitioner (PCP) health coach who delivers care remotely to patients through the patient portal of an electronic medical record (EMR).
详细描述
This study is a 24-month, two-arm, parallel controlled trial in a primary care setting. A total of 352 Black adults with obesity and type 2 diabetes or prediabetes will be randomized to either 1) intervention or 2) usual care. The intervention arm will receive a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Obesity Guidelines, delivered remotely using eHealth technology, by trained health coaches embedded in the Digital Medicine Group in the Ochsner Health System. The intervention will include remote sessions with the health coach using evidence-based components such as the use of portion control and various behavioral strategies. Patients in the usual care arm will receive their normal, usual care from their primary care team. All patients will participate in the collection of patient-reported outcomes at baseline and approximately 6, 12, and 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40-70 years of age
- •Self-identify as Black/African American
- •Obesity (BMI 30.0-50.0 kg/m2)
- •Type II diabetes (based on ICD-10 codes, fasting plasma glucose ≥126 mg/dL, HbA1c ≥6.5%, 2-h plasma glucose during 75-g Oral Glucose Tolerance Test (OGTT) ≥200 mg/dL, or a random plasma glucose ≥200 mg/dL in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis) or pre-diabetes (based on ICD-10 codes, fasting glucose 100-125 mg/dL or HbA1c 5.7-6.4% or 2-h glucose during 75-g OGTT 140-199 mg/dL)
- •Has an internet-connected device and is willing to use it for intervention delivery
- •Patient in the Ochsner Health System with an active MyOchsner portal account, or willing to create one
- •Acknowledgement from their Ochsner primary care practitioner that there are no known contraindications to the patient's participation
- •Have weight measured at an Ochsner clinic within 4 weeks of screening
- •Resident of Louisiana
- •Be able to provide informed consent
- •Willing to change diet and/or physical activity
排除标准
- •Body weight ≥ 400 lbs.
- •Current use of weight loss medication or recent weight loss (net loss >10 lbs in the last six months)
- •Currently participating in a structured weight loss program
- •Plans to move from the area within 2 years
- •Given birth within the past year, is currently pregnant or breastfeeding or plans to become pregnant within 2 years
- •Past bariatric surgery or plans for bariatric surgery within 2 years
- •Disease/condition that is life threatening or can interfere with or be aggravated by exercise or weight loss
研究组 & 干预措施
Usual Care
Patients in the usual care arm will receive their normal, usual care from their primary care team.
Intensive Lifestyle Intervention
The intervention arm receives a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Obesity Guidelines, delivered remotely using eHealth technology, by trained health coaches embedded in the Digital Medicine Group in the Ochsner Health System. The intervention includes remote sessions with the health coach using evidence-based components such as the use of portion control and various behavioral strategies .Patients in the Intervention arm attend weekly sessions in the first six months, followed by monthly sessions for the remaining 18 months.
干预措施: Intensive Lifestyle Intervention (Behavioral)
结局指标
主要结局
Body weight (Percent Change)
时间窗: Percent (%) Change from Baseline to Month 24
Body weight is measured in light indoor clothes and is obtained from the electronic medical record.
次要结局
- HbA1c(Change from Baseline to Month 24)
- Triglycerides(Change from Baseline to Month 24)
- Low-density Lipoprotein (LDL) cholesterol(Change from Baseline to Month 24)
- Physical Activity(Change from Baseline to Month 24)
- Dietary Intake(Change from Baseline to Month 24)
- Body weight (kg)(Change in kg from Baseline to Month 24)
- Total Cholesterol(Change from Baseline to Month 24)
- High-density Lipoprotein (HDL) Cholesterol(Change from Baseline to Month 24)
- Systolic Blood Pressure(Change from Baseline to Month 24)
- Diastolic Blood Pressure(Change from Baseline to Month 24)
- Impact of Weight on Quality of Life-Lite-Clinical Trials Questionnaire(Change from Baseline to Month 24)
- EuroQol-5 Dimension Questionnaire(Change from Baseline to Month 24)
- Health Care Utilization Questionnaire(Change from Baseline to Month 24)
- Perceived Stress Scale-4 Questionnaire(Change from Baseline to Month 24)
研究者
Peter T. Katzmarzyk
Associate Executive Director for Population and Public Health
Pennington Biomedical Research Center