Status:
RECRUITING
DAta-driven personaLIzation of a digitAl Health Solution to Support Family Caregivers of Children With Chronic Conditions
Lead Sponsor:
Adhera Health, Inc.
Collaborating Sponsors:
Hospital Universitario Miguel Servet, Zaragoza
University of Valencia
Conditions:
Obesity, Childhood
Eligibility:
All Genders
18+ years
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 th...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
March 11 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06520787
Start Date
March 11 2025
End Date
May 1 2026
Last Update
December 1 2025
Active Locations (1)
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1
Hospital Universitario Miguel Servet
Zaragoza, Aragon, Spain, 50009