Personalized digital support plus medication for teens with obesity
DAta-driven personaLIzation of a digitAl Health Solution to Support Family Caregivers of Children With Chronic Conditions
This project will try a personalized digital support program alongside prescribed weight‑loss medication to see if it improves treatment satisfaction, adherence, and mood for families of teens with obesity.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Adhera Health, Inc. Industry-sponsored |
| Locations | 1 site (Zaragoza, Aragon) |
| Trial ID | NCT06520787 on ClinicalTrials.gov |
What this trial studies
This is a feasibility, observational program that pairs the Adhera Caring Digital Program® (ACDP®) with prescribed pharmacological treatment for adolescents with obesity to explore family needs and outcomes. Caregivers of adolescents aged 13–18 who are already on approved obesity medications (for example orlistat, metformin, liraglutide, or semaglutide) will use the ACDP® for about 10 months while the patient continues medication for one year. Participants will wear activity wristbands to collect biometric data, receive personalized messages and educational content via the app, and attend monthly clinic visits at the coordinating site. Key outcomes include treatment satisfaction, engagement, adherence, mood, and a better understanding of families' educational and support needs during treatment and lifestyle change.
Who should consider this trial
Good fit: Ideal candidates are families of adolescents aged 13–18 with obesity (BMI ≥95th percentile for age/sex) who are already receiving an approved pharmacological treatment and are willing to use a smartphone app and wearables and attend monthly clinic visits.
Not a fit: Patients who are not taking pharmacological obesity treatment, are younger than 13, cannot use a smartphone or wearables, or cannot attend monthly visits are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, combining personalized digital coaching with medication could improve how satisfied families feel with treatment, help teens stick with medication and lifestyle changes, and support caregiver wellbeing.
How similar studies have performed: Combined digital support and pharmacological treatment has shown promise in adult obesity care, but evidence in adolescents is limited and this program is relatively novel in the pediatric population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Caregivers of children between 13 and 18 years who are diagnosed with obesity and undergoing treatment according to the approved label by AEMPS1 (adolescents with obesity aged 12 years and older with an initial BMI at the 95th percentile or greater for age and sex). * Families of children with obesity who have been under pharmacological treatment before screening. This includes treatment with any of the following medications orlistat, metformin, liraglutide, semaglutide. * Participants who are willing to join ACDP® for 10 months and can interact with a smartphone during that time. * The family is willing to complement the pharmacological obesity treatment with a digital intervention. * Participants (patients and their caregivers) must be willing to use wearables for the entire length of the study. * Parents previously using a wearable will agree not to use it during the length of the study, as their wearable account must be synched to the patient's device. Further, they may need to agree on changing the account data for height, weight, and gender in their Google account. Exclusion criteria: * Families not fluent in Spanish. * Families of children with obesity and comorbidities. * Families of children with secondary causes of obesity (i.e., hypothalamic, genetic or endocrine causes).
Where this trial is running
Zaragoza, Aragon
- Hospital Universitario Miguel Servet — Zaragoza, Aragon, Spain (Recruiting)
Study contacts
- Study coordinator: Luis Fernadez-Luque, Dr
- Email: luis@adherahealth.com
- Phone: +34 656930901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.