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
- Enrolling By Invitation
- 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
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
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
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)
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)
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)
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
研究点 (1)
标识符
- NCT 编号
- NCT07404189
- 其他研究编号
- IRB-300015959
日期
- 首次提交
- (7个月前)
- 首次发布
- (7个月前)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
A fully de-identified dataset will be shared at the time of publication of the primary results of this trial. The dataset will enable other investigators to replicate the primary study analysis.