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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Feasibility of the ACDP-O Intervention [Срок оценки: Baseline to Day 90]
• Acceptability of the ACDP-O Intervention [Срок оценки: Day 90]
• Change in Mental Well-being (DASS-21) [Срок оценки: Baseline and Day 90]
• Change in Family Well-being [Срок оценки: Baseline and Day 90]
• Change in Quality of Life (Distress) [Срок оценки: Baseline and Day 90]
• Change Quality of Life (KIDSCREEN-10) [Срок оценки: Baseline and Day 90]

Вторичные конечные точки (4)

• Change in Glycemic Control (T1D Cohorts) [Срок оценки: Baseline and Day 90]
• Change in Hypoglycemia Awareness (T1D Cohorts) [Срок оценки: Baseline and Day 90]
• Participant Engagement [Срок оценки: Day 1 to Day 90]
• Change in diabetes-related well-being (Diabetes cohort) [Срок оценки: Baseline and Day 90]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Испания · 1 центр

• Adhera Health (Virtual Participation) — Seville

Идентификаторы

NCT: NCT07638345 · DASH-Obesity

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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