Evaluation of the Acceptability and Clinical Effectiveness of Augmenting Comprehensive Primary Care-Based Obesity Management With the Nutu™ Digital Health Platform
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Body Weight
研究概览
简要总结
This study evaluates the acceptability and clinical effectiveness of integrating the Nutu™ digital health platform into a comprehensive primary care-based behavioral obesity treatment program using a Zelen randomized controlled trial design.
详细描述
This pragmatic randomized clinical trial is conducted within the established FLOW program, a 12-month multidisciplinary behavioral obesity treatment aligned with USPSTF recommendations. Patients initiating FLOW are randomized to standard care or FLOW augmented with an offer of Nutu™, an AI-powered digital health platform providing behavioral support and self-monitoring tools. Outcomes are collected quarterly over 12 months using routinely collected clinical data.
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
- None
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
- •All patients enrolled in the FLOW clinical program are eligible.
排除标准
- •Not a patient of the FLOW clinical program at UAB.
研究组 & 干预措施
Standard FLOW Program
Participants receive the standard 12-month FLOW program including nutrition counseling, physician visits, and behavioral health support.
干预措施: FLOW Program (Behavioral)
FLOW + Nutu™ Offer
Participants receive standard FLOW care and are offered access to the Nutu™ digital health platform, which may be accepted or declined.
干预措施: FLOW Program (Behavioral)
FLOW + Nutu™ Offer
Participants receive standard FLOW care and are offered access to the Nutu™ digital health platform, which may be accepted or declined.
干预措施: Nutu™ Offer (Behavioral)
结局指标
主要结局
Body Weight
时间窗: Baseline to 12 months
Difference in body weight change between groups
次要结局
- Nutu™ Acceptance(Baseline)
- Nutu™ Engagement(Baseline through 12 months)
研究者
Drew Sayer
Assistant Professor
University of Alabama at Birmingham