Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
