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

June 5, 2026 updated by: Adhera Health, Inc.

US-based Clinical Sub-study of DASH-Obesity: Explainable AI for Family-Centric Transdiagnostic Personalized Weight Control Across Multiple Conditions

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Seville, Spain
        • Recruiting
        • Adhera Health (Virtual Participation)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Adhera Caring Digital Program-Obesity (ACDP-O)
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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the ACDP-O Intervention
Time Frame: Baseline 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.
Baseline to Day 90
Acceptability of the ACDP-O Intervention
Time Frame: Day 90
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
Time Frame: 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.
Baseline and Day 90
Change in Quality of Life (PedsQL)
Time Frame: Baseline and Day 90
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
Time Frame: Baseline 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.
Baseline and Day 90
Change in Quality of Life (Distress)
Time Frame: 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.
Baseline and Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycemic Control (T1D Cohorts)
Time Frame: Baseline and Day 90
Change in self-reported HbA1c. Difference between baseline and post-intervention HbA1c values among participants with Type 1 Diabetes.
Baseline and Day 90
Change in Hypoglycemia Awareness (T1D Cohorts)
Time Frame: Baseline and Day 90
Change in Clarke Hypoglycemia Awareness Scale score.
Baseline and Day 90
Change in Asthma Control (Asthma Cohort)
Time Frame: Baseline and Day 90
Change in Asthma Control Questionnaire (ACQ) score.
Baseline and Day 90
Change in Caregiver Burden (PAID)
Time Frame: Baseline and Day 90
Change in Problem Areas in Diabetes (PAID) Score The PAID questionnaire evaluates diabetes-related emotional distress. Scores range from 0 to 100, with higher scores indicating greater emotional burden. The outcome is the change from baseline to Day 90.
Baseline and Day 90
Participant Engagement
Time Frame: Day 1 to Day 90
Frequency of application use and intervention adherence. Measured through platform usage logs and completion of assigned activities.
Day 1 to Day 90
Change in Caregiver Burden (PIP)
Time Frame: Baseline and Day 90
Change in Pediatric Inventory for Parents (PIP) Total Score The PIP assesses parenting stress associated with caring for a child with a chronic illness. Higher scores indicate greater parenting stress. The outcome is the change in total score from baseline to Day 90.
Baseline and Day 90
Change in Caregiver Burden (HFS)
Time Frame: Baseline and Day 90
Change in Hypoglycemia Fear Survey (HFS) Total Score The HFS measures fear and behavioral responses related to hypoglycemia. Higher scores indicate greater fear of hypoglycemia. The outcome is the change in total score from baseline to Day 90.
Baseline and Day 90
Change in Treatment Satisfaction (DTSQ)
Time Frame: Baseline and Day 90
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Total Score The DTSQ evaluates satisfaction with diabetes treatment. Higher scores indicate greater treatment satisfaction. The outcome is the change in total score from baseline to Day 90.
Baseline and Day 90
Change in Sleep Quality (PSQI)
Time Frame: Baseline and Day 90
Change in Pittsburgh Sleep Quality Index (PSQI) Global Score The PSQI assesses sleep quality during the previous month. Global scores range from 0 to 21, with higher scores indicating poorer sleep quality. The outcome is the change in global score from baseline to Day 90.
Baseline and Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adhera Health, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2025

Primary Completion (Actual)

March 27, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

June 5, 2026

First Submitted That Met QC Criteria

June 5, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DASH-Obesity

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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