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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. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

280

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Spanien
      • Seville, Spanien
        • Rekruttering
        • Adhera Health (Virtual Participation)
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of the ACDP-O Intervention
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Glycemic Control (T1D Cohorts)
Tidsramme: 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)
Tidsramme: Baseline and Day 90
Change in Clarke Hypoglycemia Awareness Scale score.
Baseline and Day 90
Change in Asthma Control (Asthma Cohort)
Tidsramme: Baseline and Day 90
Change in Asthma Control Questionnaire (ACQ) score.
Baseline and Day 90
Change in Caregiver Burden (PAID)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Adhera Health, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. oktober 2025

Primær færdiggørelse (Faktiske)

27. marts 2026

Studieafslutning (Anslået)

1. september 2026

Datoer for studieregistrering

Først indsendt

5. juni 2026

Først indsendt, der opfyldte QC-kriterier

5. juni 2026

Først opslået (Faktiske)

10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DASH-Obesity

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Type 1 diabetes

Kliniske forsøg med Adhera Caring Digital Program-Obesity (ACDP-O)

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