Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06520787

DAta-driven personaLIzation of a digitAl Health Solution to Support Family Caregivers of Children With Chronic Conditions

Led by Adhera Health, Inc. · Updated on 2025-12-01

40

Participants Needed

1

Research Sites

59 weeks

Total Duration

On this page

Sponsors

A

Adhera Health, Inc.

Lead Sponsor

H

Hospital Universitario Miguel Servet, Zaragoza

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

DAta-driven personaLIzation of a digitAl Health Solution to Support Family Caregivers of Children With Chronic Conditions

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Caregivers of children aged 13 to 18 years diagnosed with obesity and under approved pharmacological treatment
  • Children with obesity treated with orlistat, metformin, liraglutide, or semaglutide before screening
  • Willingness to participate in the Adhera Caring Digital Program� for 10 months using a smartphone
  • Families agreeing to combine pharmacological treatment with the digital intervention
  • Willingness of patients and caregivers to use wearable devices for the entire study duration
  • Parents previously using a wearable agree not to use it during the study and to synchronize their account with the patient's device
Not Eligible

You will not qualify if you...

  • Families not fluent in Spanish
  • Children with obesity who have additional medical conditions (comorbidities)
  • Children with obesity caused by secondary factors such as hypothalamic, genetic, or endocrine disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Universitario Miguel Servet

Zaragoza, Aragon, Spain, 50009

Actively Recruiting

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Research Team

L

Luis Fernadez-Luque, Dr

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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