Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07638345

Recruiting nowNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersAccepted

ConditionType 1 Diabetes, T1D, Obesity & Overweight, Obesity Type 2 Diabetes Mellitus, Asthma Acute, Asthma (Diagnosis)

Full registry criteria

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.

Treatments and study arms

Adhera Caring Digital Program-Obesity (ACDP-O)

Behavioral

The Adhera Caring Digital Program-Obesity (ACDP-O) is a mobile-based digital health intervention that provides personalized educational content, cognitive behavioral approach-based support, psychometric monitoring, wearable-device integration, remote monitoring, and explainable artificial intelligence tools. The intervention is designed to support weight management, healthy lifestyle behaviors, mental well-being, quality of life, and family engagement in adolescents and young adults with obesity and chronic conditions

Primary outcomes

Feasibility of the ACDP-O InterventionBaseline to Day 90

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.

Acceptability of the ACDP-O InterventionDay 90

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

Change in Mental Well-being (DASS-21)Baseline and Day 90

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.

Change in Family Well-beingBaseline and Day 90

Change in Computer Adaptive Testing (CAT)-based family well-being scores. Family well-being assessed through adaptive psychometric assessments derived from validated mental health questionnaires.

Change in Quality of Life (Distress)Baseline and Day 90

Change in Distress Thermometer Score The Distress Thermometer is a single-item measure of psychological distress scored from 0 (no distress) to 10 (extreme distress). Higher scores indicate greater distress. The outcome is the change from baseline to Day 90.

Change Quality of Life (KIDSCREEN-10)Baseline and Day 90

The KIDSCREEN-10 Index is a validated measure of health-related quality of life in children and adolescents. Raw scores are converted to a standardized T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate better health-related quality of life and a better outcome. The outcome measure is the change in KIDSCREEN-10 Index score from baseline to Day 90.

Study locations

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Adhera Health (Virtual Participation)🇪🇸 Seville, Spain

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Sara BelónContact

Email · Call +1 (831) 345-5357