NCT06520787 DAta-driven personaLIzation of a digitAl Health Solution to Support Family Caregivers of Children With Chronic Conditions
| NCT ID | NCT06520787 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Adhera Health, Inc. |
| Condition | Obesity, Childhood |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-03-11 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2025-03-11 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06520787 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obesity, Childhood. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06520787 currently recruiting?
Yes, NCT06520787 is actively recruiting participants. Contact the research team at luis@adherahealth.com for enrollment information.
Where is the NCT06520787 trial being conducted?
This trial is being conducted at Zaragoza, Spain.
Who is sponsoring the NCT06520787 clinical trial?
NCT06520787 is sponsored by Adhera Health, Inc.. The trial plans to enroll 40 participants.
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