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

NCT07638345 | Recruiting

• 1 other identifier: DASH-Obesity
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Pediatric Obesity; Type 1 Diabetes; Asthma; Overweight; Digital Health; Artificial Intelligence; Explainable AI; Caregiver Burden; Quality of Life; Mental Well-being; Wearable Devices; Family-Centered Care

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  Day 90

• Change in Mental Well-being

  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.

  Baseline and Day 90

• Change in Quality of Life (PedsQL)

  Change in Pediatric Quality of Life Inventory (PedsQL) Total Score The PedsQL assesses health-related quality of life across physical, emotional, social, and school functioning domains. Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life. The outcome is the change from baseline to Day 90.

  Baseline and Day 90

• Change in Family Well-being

  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.

  Baseline and Day 90

• Change in Quality of Life (Distress)

  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.

  Baseline and Day 90

Secondary Outcomes (9)

• Change in Glycemic Control (T1D Cohorts)

  Baseline and Day 90

• Change in Hypoglycemia Awareness (T1D Cohorts)

  Baseline and Day 90

• Change in Asthma Control (Asthma Cohort)

  Baseline and Day 90

• Change in Caregiver Burden (PAID)

  Baseline and Day 90

• Participant Engagement

  Day 1 to Day 90

Study Arms (1)

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

EXPERIMENTAL

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.

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

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adhera Health, Inc.: lead

Study Sites (1)

Adhera Health (Virtual Participation)

Seville, Spain

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Obesity; Overweight; Asthma; Disease; Pediatric Obesity; Caregiver Burden; Psychological Well-Being

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Pathologic Processes; Stress, Psychological; Behavioral Symptoms; Behavior; Personal Satisfaction

Central Study Contacts

Luis Fernández Luque, PhD

CONTACT

+1 (831) 345-5357; luis@adherahealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-group assignment study in which all participants receive the ACDP-O digital intervention. Outcomes are evaluated using a pre-post design over a 3-month intervention period, with comparisons conducted across predefined disease and weight-status cohorts.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start: October 30, 2025
• Primary Completion: March 27, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

ES (1)