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

NCT06520787 | Recruiting

• 1 other identifier: DAL-CLI-24-001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Obesity; Digital health; Treatment satisfaction; pharmacological treatment for obesity

Outcome Measures

Primary Outcomes (4)

• Treatment satisfaction

  Treatment satisfaction measured by Treatment Expectation Scale/Treatment Satisfacyion Scale. Minimum Value: 0. Maximum Value: 10. Interpretation: Higher scores indicate better outcomes (greater treatment expectation/satisfaction).

  Day 1 to Day 365

• Treatment adherence 1

  Treatment adherence measured by injection (self-reported). Unit of measure: Number of injections (quantitative data)

  Day 1 to Day 365

• Treatment adherence 2

  Treatment adherence measured by changes in nutritional compliance (self-reported). Unit of measure: Description of diet (qualitative data).

  Day 1 to Day 365

• Treatment adherence 3

  Treatment adherence measured by discontinuation (and reasons behind it). Unit of measure: Incidence of discontinuation with categorized reasons.

  Day 150 to Day 365

Secondary Outcomes (19)

• Emotional outcome 1

  Baseline (Day 1) to Day 365

• Emotional outcome 2

  Baseline (Day 1) to Day 365

• Emotional outcome 3

  Baseline (Day 1) to Day 365

• Health-related Quality of Life (HrQoL)

  Baseline (Day 1) to Day 365

• Levels of physical activity

  Baseline (Day 1) to Day 365

Study Arms (1)

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)

Combination Product: ACDP® and pharmacological treatment for obesity

Interventions

ACDP® and pharmacological treatment for obesity 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).

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The sample of the study (caregivers) will be recruited from the Pediatric Endocrinology unit at the Miguel Servet Children's University Hospital. This public hospital provides pediatric health attention to the regional area of Zaragoza (Spain), which covers a total of 367.110 inhabitants. Families of children with obesity that are already undergoing treatment and are willing to join a combined intervention.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Adhera Health, Inc.: lead
• Hospital Universitario Miguel Servet, Zaragoza: collaborator
• University of Valencia: collaborator
• University of Seville: collaborator

Study Sites (1)

Hospital Universitario Miguel Servet

Zaragoza, Aragon, 50009, Spain

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Interventions

2-amino-3-cyano-6-methyl-5-(3,4-dimethoxyphenyl)pyridine; Drug Therapy; Adiposity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Body Fat Distribution; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Body Composition; Biochemical Phenomena; Chemical Phenomena; Metabolism; Physiological Phenomena

Central Study Contacts

Luis Fernadez-Luque, Dr

CONTACT

+34 656930901; luis@adherahealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 25, 2024
• Study Start: March 11, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)