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

Adhera Health, Inc.280 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

280

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Feasibility of the ACDP-O Intervention

Participant completion rate of the 3-month digital intervention. Feasibility will be assessed as the proportion of enrolled participants who complete the intervention and final study assessments.

Time frame: Baseline to Day 90

Acceptability of the ACDP-O Intervention

Participant and caregiver satisfaction with the intervention. Acceptability will be assessed using post-intervention satisfaction surveys based on a 5-point Likert scale.

Time frame: Day 90

Change in Mental Well-being (DASS-21)

Change in Depression Anxiety Stress Scales (DASS-21) scores. The DASS-21 is a 21-item self-report questionnaire assessing symptoms of depression, anxiety, and stress. Total scores range from 0 to 63, with higher scores indicating greater psychological distress. The outcome is the change from baseline to Day 90.