DASH-Obesity: Explainable AI for Family-Centric Personalized Weight Control in Adolescents and Young Adults With Obesity and Chronic Conditions (DASH-Obesity)
19 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Estimado)
280
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Luis Fernández Luque, PhD
- Número de teléfono: +1 (831) 345-5357
- Correo electrónico: luis@adherahealth.com
Ubicaciones de estudio
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Seville, España
- Reclutamiento
- Adhera Health (Virtual Participation)
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Contacto:
- Sara Belón
- Número de teléfono: +1 (831) 345-5357
- Correo electrónico: studies@adherahealth.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility of the ACDP-O Intervention
Periodo de tiempo: 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.
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Baseline to Day 90
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Acceptability of the ACDP-O Intervention
Periodo de tiempo: 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
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Change in Family Well-being
Periodo de tiempo: Baseline and Day 90
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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)
Periodo de tiempo: Baseline and Day 90
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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
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Change in Mental Well-being (DASS-21)
Periodo de tiempo: Baseline and Day 90
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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)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Glycemic Control (T1D Cohorts)
Periodo de tiempo: Baseline and Day 90
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Change in self-reported HbA1c.
Difference between baseline and post-intervention HbA1c values among participants with Type 1 Diabetes.
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Baseline and Day 90
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Participant Engagement
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
30 de octubre de 2025
Finalización primaria (Actual)
27 de marzo de 2026
Finalización del estudio (Estimado)
1 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
5 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de junio de 2026
Publicado por primera vez (Actual)
10 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
19 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Procesos Patológicos
- Trastornos Nutricionales
- Enfermedades metabólicas
- Sobrenutrición
- Peso corporal
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Síntomas de comportamiento
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Enfermedades bronquiales
- Enfermedades Pulmonares Obstructivas
- Hipersensibilidad Respiratoria
- Hipersensibilidad, Inmediata
- Hipersensibilidad
- Estrés Psicológico
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Satisfacción personal
- Carga del cuidador
- Exceso de peso
- Obesidad
- Asma
- Enfermedad
- Diabetes Mellitus, Tipo 1
- Obesidad Pediátrica
- Bienestar psicológico
Otros números de identificación del estudio
- DASH-Obesity
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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