DAta-driven PersonaLIzation of a DigitAl Health Solution to Support Family Caregivers of Children with Chronic Conditions (DALIA)

Adhera Health

Status: Not yet enrolling

Conditions: Obesity, Childhood

Treatments: Combination Product: ACDP® and pharmacological treatment for obesity

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06520787

DAL-CLI-24-001

Details and patient eligibility

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

40 participants in 1 patient group

Cohort

Description:

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)

Treatment:

Combination Product: ACDP® and pharmacological treatment for obesity