Type 1 Diabetes (T1D) Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Spain
Adhera Health (Virtual Participation)
RECRUITING
Seville
Contact Information
Primary
Luis Fernández Luque, PhD
luis@adherahealth.com
+1 (831) 345-5357
Time Frame
Start Date: 2025-10-30
Estimated Completion Date: 2026-09
Participants
Target number of participants: 280
Treatments
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.
Sponsors
Leads: Adhera Health, Inc.

This content was sourced from clinicaltrials.gov