Coordinating Pragmatic Primary Care Population Management for Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of Participants Who Achieved 5% Weight Loss Goal at 6 Months
研究概览
简要总结
The C3PO pilot and feasibility study uses a rigorous, mixed-method research design to provide information needed to refine and implement a technology-mediated primary care outreach intervention approach before conducting a larger and more definitive future intervention trial.
详细描述
This study will implement and evaluate a pragmatic and generalizable framework for population management of obesity by the primary care sector. With patient and other stakeholder input, the C3PO intervention will be designed to leverage existing primary care professionals and technologies to implement a scalable framework for population obesity management that coordinates primary care services with extant intensive lifestyle interventions in community settings to achieve wider reach and population-level effectiveness. A rigorous, mixed-method pilot and feasibility study will provide critical information needed to optimize the intervention design and prepare us for a larger and definitive future trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Patients will be randomized to either Basic Resources and Services or the C3PO intervention arm. Although patients will be aware of the specific forms of support they are receiving throughout the trial, each individual will not be aware that they are part of a randomized experiment and will not know that other patients may be receiving different levels of support. For this reason, the non-concealed nature of the behavioral support intervention for participating patients should not introduce bias. Investigators and outcome assessors will not be aware of intervention assignment during the study conduct or evaluation phase.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥ 27 kg/m2
- •≥ 1 CVD risk condition (hypertension, dyslipidemia, prediabetes or type 2 diabetes)
- •Registered in Northwestern Medical Group's EpicCare MyChart patient portal
- •Received and completed MyChart survey of weight loss interest
- •Affirms interest in weight loss goal setting and receiving additional resource information and electronic Scale.
排除标准
- •Evidence of hospitalization in past 30 days
- •Most recent blood pressure >180/105
- •Cancer (non-skin) treatment within the past 2 years
- •Encounter diagnosis for hypoglycemia in past 30 days
- •Actively receiving care from the bariatric surgery service or a bariatric medication order in the past 100 days
结局指标
主要结局
Number of Participants Who Achieved 5% Weight Loss Goal at 6 Months
时间窗: Baseline - 6 Months
Proportion of Participants who Reach a 5% Weight Loss Goal at 6 Months, calculated as the percent of all participants for whom the following calculation is greater than or equal to 5%: (Baseline body mass (kg) - Body mass measured at 6 months (kg))/(Baseline body mass (kg))
次要结局
- Costs to Implement the Intervention(Baseline - 12 Months)
- Change in Hemoglobin A1C(Baseline - 12 Months)
- Change in Total Cholesterol(Baseline - 12 Months)
- Body Mass Change at 6 Months(Baseline - 6 Months)
- Body Mass Change at 12 Months(Baseline - 12 Months)
- Number of Participants Who Achieved 5% Weight Loss Goal in 12 Months(Baseline - 12 Months)
- Change in Systolic Blood Pressure(Baseline - 12 Months)
- Change in Non-HDL Cholesterol(Baseline - 12 Months)
研究者
Ronald Ackermann
Professor of Medicine
Northwestern University