DASH-Obesity: Explainable AI for Family-Centric Personalized Weight Control in Adolescents and Yo… (NCT07638345) | Clinical Trial Compass
RecruitingNot Applicable
DASH-Obesity: Explainable AI for Family-Centric Personalized Weight Control in Adolescents and Young Adults With Obesity and Chronic Conditions
Spain280 participantsStarted 2025-10-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses something called 'explainable AI' for weight management in teens and young adults with conditions like Type 1 diabetes or asthma — can you help me understand what that actually means in practice, and whether this kind of approach makes sense given my specific diagnosis?
2Since this is listed as Phase NA, which often means it's a feasibility or pilot study focused on whether the program even works in real life, does that mean there's less safety and effectiveness data than a later-phase trial would have, and how should that affect our thinking?
3The trial is measuring things like family well-being and quality of life alongside weight-related outcomes — how involved would my family need to be, and is that level of participation realistic for our situation?
4Given that this study includes people with very different conditions — Type 1 diabetes, Type 2 diabetes, and asthma — would you say my particular diagnosis and health history are a good fit for what this program is designed to do?
5Before considering this trial, are there standard treatment options or existing programs for managing obesity alongside my chronic condition that I should try first, or would participating in this study be a reasonable path to explore right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.