DASH-Obesity: Explainable AI for Family-Centric Personalized Weight Control in Adolescents and Young Adults With Obesity and Chronic Conditions

Adhera Health

Status: Enrolling

Conditions: Type 1 Diabetes; T1D; Obesity & Overweight; Asthma (Diagnosis); Obesity Type 2 Diabetes Mellitus; Asthma Acute

Treatments: Behavioral: Adhera Caring Digital Program-Obesity (ACDP-O)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07638345

DASH-Obesity

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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280 participants in 1 patient group

Experimental: Adhera Caring Digital Program-Obesity (ACDP-O)

Experimental group

Description:

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.

Treatment:

Behavioral: Adhera Caring Digital Program-Obesity (ACDP-O)