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

NCT06520787 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Obesity, Childhood

Interventions

COMBINATION_PRODUCT

ACDP® and pharmacological treatment for obesity

40 Families of children with obesity that are already undergoing treatment and are willing to join a combined intervention. After the recruitment, the family will join Adhera Caring Digital Program® for 10 months. The combined intervention (digital and pharmacological intervention) will last one year, and there will be a 2-month follow-up. During the whole study (12 months, from recruiting to the end of follow-up) participants will wear a smartwatch (Fitbit or similar).

Sponsors & Collaborators

  • Hospital Universitario Miguel Servet, Zaragoza

    collaborator UNKNOWN

  • University of Valencia

    collaborator OTHER

  • University of Seville

    collaborator OTHER

  • Adhera Health, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-11
Primary Completion
2026-03-19
Completion
2026-05-19

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06520787 on ClinicalTrials.gov