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

5 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

280

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Spagna
      • Seville, Spagna
        • Reclutamento
        • Adhera Health (Virtual Participation)
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility of the ACDP-O Intervention
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Glycemic Control (T1D Cohorts)
Lasso di tempo: 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)
Lasso di tempo: Baseline and Day 90
Change in Clarke Hypoglycemia Awareness Scale score.
Baseline and Day 90
Change in Asthma Control (Asthma Cohort)
Lasso di tempo: Baseline and Day 90
Change in Asthma Control Questionnaire (ACQ) score.
Baseline and Day 90
Change in Caregiver Burden (PAID)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Adhera Health, Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 ottobre 2025

Completamento primario (Effettivo)

27 marzo 2026

Completamento dello studio (Stimato)

1 settembre 2026

Date di iscrizione allo studio

Primo inviato

5 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 giugno 2026

Primo Inserito (Effettivo)

10 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • DASH-Obesity

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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