NCT06520787

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Adhera Health, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2025-03-11
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2024-07-25
• Last updated: 2025-12-01

Locations

1 site across 1 country: Spain