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

NCT ID: NCT06520787

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-11
• Study Completion Date: 2026-05-31

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 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort

40 families with children already receiving pharmacological therapy as per clinical indication will be asked to use the ACDP® for obesity. We will track their progress with the digital intervention for ten months, and there will be a 2-month follow-up (total 12 months)

ACDP® and pharmacological treatment for obesity

Intervention Type: COMBINATION_PRODUCT

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).

Interventions

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).

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Universitario Miguel Servet, Zaragoza

UNKNOWN

Sponsor Role: collaborator

University of Valencia

OTHER

Sponsor Role: collaborator

University of Seville

OTHER

Sponsor Role: collaborator

Adhera Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitario Miguel Servet

Zaragoza, Aragon, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Luis Fernadez-Luque, Dr

Role: CONTACT

luis@adherahealth.com

+34 656930901

Facility Contacts

Antonio de Arriba MD, PhD

Role: primary

adearriba@salud.aragon.es

+34

Other Identifiers

DAL-CLI-24-001

Identifier Type: -

Identifier Source: org_study_id