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RECRUITING
NCT06520787

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

Sponsor: Adhera Health, Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2025-03-11

Completion Date

2026-05

Last Updated

2025-12-01

Healthy Volunteers

Yes

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).

Locations (1)

Hospital Universitario Miguel Servet

Zaragoza, Aragon, Spain