US-based Clinical Sub-study of DASH-Obesity: Explainable AI for Family-Centric Transdiagnostic Personalized Weight Control Across Multiple Conditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 1
研究概览
简要总结
This prospective single-arm feasibility study evaluates the Adhera Caring Digital Program for Obesity (ACDP-O), a family-centered digital health intervention designed to support adolescents and young adults with overweight/obesity and chronic conditions, including type 1 diabetes (T1D) and asthma. The intervention combines personalized educational content, wearable-device monitoring, psychometric assessments, and explainable artificial intelligence (AI) to improve mental well-being, quality of life, and adherence to healthy lifestyle behaviors. A total of 280 families will participate in a 3-month intervention with remote monitoring and follow-up assessments.
详细描述
The DASH-Obesity clinical sub-study investigates the feasibility, acceptability, and preliminary effectiveness of the Adhera Caring Digital Program for Obesity (ACDP-O) among families of adolescents and young adults affected by overweight/obesity and chronic conditions.
The intervention utilizes a mobile digital health platform that integrates educational content, behavioral support, psychometric monitoring, wearable-generated digital biomarkers, and explainable AI-based analytics. Participants include adolescents and young adults with overweight/obesity and type 1 diabetes, overweight/obesity and asthma, and a comparison cohort of participants with type 1 diabetes and normal weight.
The study follows a prospective, single-arm, pre-post basket trial design. Participants will complete baseline assessments, engage with the intervention for 90 days, and complete post-intervention and follow-up assessments. Outcomes include feasibility, acceptability, mental well-being, quality of life, caregiver burden, usability, engagement, and disease-specific clinical measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Adult caregiver (aged 18 years or older) of an adolescent or young adult aged 12 to 21 years diagnosed with Type 1 Diabetes (T1D) or asthma.
- •The caregiver is actively involved in the management of the adolescent's or young adult's condition.
- •The adolescent or young adult must meet one of the following criteria:
- •T1D and normal weight (BMI between the 10th and 85th percentile), or
- •T1D and overweight/obesity (BMI ≥85th percentile), or
- •Asthma and overweight/obesity (BMI ≥85th percentile).
- •Willingness to participate in the Adhera Caring Digital Program-Obesity (ACDP-O).
- •Access to a smartphone or internet-enabled device compatible with the study application.
- •Willingness to provide self-reported information regarding the adolescent's or young adult's health status, including disease-related and anthropometric measures.
- •For caregivers of participants with T1D, willingness to share continuous glucose monitoring (CGM) information.
排除标准
- •Severe psychiatric or cognitive conditions that would interfere with participation in the digital intervention.
- •Current participation in another obesity- or chronic disease-related digital health intervention study.
- •Inability or unwillingness to comply with study procedures.
- •Refusal or inability to provide informed consent.
研究组 & 干预措施
Experimental: Adhera Caring Digital Program-Obesity (ACDP-O)
Participants receive the Adhera Caring Digital Program-Obesity (ACDP-O), a family-centered digital health intervention delivered through a mobile application for 3 months. The intervention includes personalized educational content, psychometric assessments, wearable-device integration, remote monitoring, behavioral support, and explainable AI-driven feedback to support weight management, mental well-being, and quality of life among adolescents and young adults with type 1 diabetes or asthma and their caregivers.
干预措施: Adhera Caring Digital Program-Obesity (ACDP-O) (Behavioral)
结局指标
主要结局
未指定
次要结局
- Change in Hypoglycemia Awareness (T1D Cohorts)(Baseline and Day 90)