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NCT07638345
DASH-Obesity: Explainable AI for Family-Centric Personalized Weight Control in Adolescents and Young Adults With Obesity and Chronic Conditions
Conditions: Type 1 Diabetes, T1D, Obesity & Overweight, Obesity Type 2 Diabetes Mellitus, Asthma Acute, Asthma (Diagnosis)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 280
Sponsor: Adhera Health, Inc.
Location: Adhera Health (Virtual Participation) Seville
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07638345). StuddyBuddy aggregates publicly available trial information.