NCT06520787Completed
DAta-driven personaLIzation of a digitAl Health Solution to Support Family Caregivers of Children With Chronic Conditions
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
The goal of this feasibility study is to explore the needs of families with children with obesity and evaluate the impact of a combined intervention (children with obesity receiving pharmacological therapy in combination with the Adhera Caring Digital Program®) on treatment satisfaction, adherence, and mood. The main objectives are: * To evaluate the impact of the treatment combination (ACDP® and pharmacological treatment) in terms of satisfaction, engagement, adherence and mood, in families with children with obesity. * To better understand the educational and support needs of the families of children with obesity while under treatment and lifestyle changes. Participants will: * Use the Adhera Caring Digital Program® (ACDP®) for obesity, which includes digital therapeutic software, personalized messages, and educational materials. * Take pharmacological treatment as prescribed for one year. * Wear activity wristbands/watches to collect biometric data. * Attend monthly clinic visits for assessments and monitoring. * Complete psychometric questionnaires to measure satisfaction, adherence, and emotional outcomes. * Engage in chat-based communication and video conferencing with health coaches for support and monitoring.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 40 (actual)
- First submitted
- 4 Jul 2024
- Start date
- 11 Mar 2025
- Primary completion date
- 19 Mar 2026
- Lead sponsor
- Adhera Health, Inc.
- Diseases
- Obesity
- NCT number
- NCT06520787
What you commit to
- Study type: Observational
- Participants enrolled: 40
- From 11 Mar 2025 to the primary completion date, 19 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.