DASH-Obesity: Explainable AI for Family-Centric Personalized Weight Control in Adolescents and Young Adults With Obesity and Chronic Conditions (DASH-Obesity)
19. 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
- Navn: Luis Fernández Luque, PhD
- Telefonnummer: +1 (831) 345-5357
- E-mail: luis@adherahealth.com
Studiesteder
-
-
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Seville, Spanien
- Rekruttering
- Adhera Health (Virtual Participation)
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Kontakt:
- Sara Belón
- Telefonnummer: +1 (831) 345-5357
- E-mail: studies@adherahealth.com
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-
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 |
|---|---|
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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.
|
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
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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
|
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Acceptability of the ACDP-O Intervention
Tidsramme: Day 90
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Participant and caregiver satisfaction with the intervention.
Acceptability will be assessed using post-intervention satisfaction surveys based on a 5-point Likert scale.
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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.
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Baseline and Day 90
|
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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.
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Baseline and Day 90
|
|
Change in Mental Well-being (DASS-21)
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.
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Baseline and Day 90
|
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Change Quality of Life (KIDSCREEN-10)
Tidsramme: Baseline and Day 90
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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.
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Baseline and Day 90
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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
|
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Participant Engagement
Tidsramme: Day 1 to Day 90
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Frequency of application use and intervention adherence.
Measured through platform usage logs and completion of assigned activities.
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Day 1 to Day 90
|
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Change in Hypoglycemia Awareness (T1D Cohorts)
Tidsramme: Baseline and Day 90
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Change in Clarke Hypoglycemia Awareness Scale score.
The Clarke Hypoglycemia Awareness Scale is an 8-item questionnaire used to assess impaired awareness of hypoglycemia in individuals with diabetes.
Total scores range from 0 to 7, with higher scores indicating worse hypoglycemia awareness (greater impairment in recognizing hypoglycemic episodes).
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Baseline and Day 90
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Change in diabetes-related well-being (Diabetes cohort)
Tidsramme: Baseline and Day 90
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The INSPIRE Questionnaire for Parents of Youth with Type 1 Diabetes assesses parent perceptions of positive psychological and behavioral outcomes associated with diabetes management technologies and care.
Scores are transformed to a 0 to 100 scale, with higher scores indicating more positive perceptions and experiences and a better outcome.
The outcome measure is the change in total score from baseline to Day 90.
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Baseline and Day 90
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
23. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i det endokrine system
- Patologiske processer
- Ernæringsforstyrrelser
- Metaboliske sygdomme
- Overernæring
- Kropsvægt
- Autoimmune sygdomme
- Sygdomme i immunsystemet
- Adfærdsmæssige symptomer
- Luftvejssygdomme
- Lungesygdomme
- Glukosemetabolismeforstyrrelser
- Diabetes mellitus
- Bronchiale sygdomme
- Lungesygdomme, obstruktiv
- Respiratorisk overfølsomhed
- Overfølsomhed, Øjeblikkelig
- Overfølsomhed
- Stress, psykologisk
- Patologiske tilstande, tegn og symptomer
- Opførsel
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Personlig tilfredshed
- Plejerbyrde
- Overvægtig
- Fedme
- Astma
- Sygdom
- Diabetes mellitus, type 1
- Pædiatrisk fedme
- Psykologisk velvære
Andre undersøgelses-id-numre
- DASH-Obesity
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