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

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Childhood
• Intervention / Treatment: Combination product: ACDP® and pharmacological treatment for obesity

• Study Type: Observational
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Aragon
    • Zaragoza, Aragon, Spain, 50009
      • Hospital Universitario Miguel Servet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step count	From wearable device. Unit of measure: number of steps per day.	Baseline (Day 1) to Day 396
Emotional outcome 1	These tend to be sensitive to change in short-term and will include distress assessed by the Depression Anxiety and Stress Scale (DASS-21) and the distress thermometer. Minimum Value: 0. Maximum Value: 63. Interpretation: Higher scores indicate worse outcomes (greater levels of depression, anxiety, and stress).	Baseline (Day 1) to Day 365
Emotional outcome 2	These tend to be sensitive to change in short-term and will include Weight Self-Stigma Questionnaire (S-WSSQ). Minimum Value: 12. Maximum Value: 60. Interpretation: Higher scores indicate worse outcomes (greater self-stigma related to weight).	Baseline (Day 1) to Day 365
Emotional outcome 3	These tend to be sensitive to change in short-term and will include perceived self-efficacy assessment by the General Self-Efficacy Scale (GSE). Minimum Value: 10. Maximum Value: 40. Interpretation: Higher scores indicate better outcomes (greater self-efficacy).	Baseline (Day 1) to Day 365
Health-related Quality of Life (HrQoL)	Quality of life tends to change over longer periods of time, and often do require follow-ups of 6 months or one year. However, some dimensions (e.g. mental) are estimated to change faster in shorter periods. HrQoL will be assessed with regard to the children by the caregivers' perspective from the KIDSCREEN-10. Minimum Value: 10. Maximum Value: 50. Interpretation: Higher scores indicate better outcomes (better health-related quality of life).	Baseline (Day 1) to Day 365
Levels of physical activity	Life-style questionnaires on Levels of physical activity (APALQ; Assessment of Physical Activity Levels Questionnaire ). Minimum Value: Varies based on questionnaire design. Maximum Value: Varies based on questionnaire design. Interpretation: Higher scores generally indicate better outcomes (higher levels of physical activity).	Baseline (Day 1) to Day 365
Height	From bioimpedance scale. Standard medical measurement. Unit of measure: meters.	Baseline (Day 1) to Day 365
Weight	From bioimpedance scale. Standard medical measurement. Unit of measure: kilograms.	Baseline (Day 1) to Day 365
Body Mass Index (BMI)	From bioimpedance scale. Calculated from height and weight. Unit of measure: kg/m²	Baseline (Day 1) to Day 365
Blood pressure	Standard pressure measurement. Unit of measure: mmHg.	Baseline (Day 1) to Day 365
Time since diagnosis	From patient medical records or self-reported data. Unit of measure: weeks, months or years.	Baseline (Day 1) to Day 365
Previous obesity treatments	From patient medical records and self-reported data. Unit of measure: Description of treatment (qualitative data).	Baseline (Day 1) to Day 365
Cholesterol levels	Blood test results. Unit of measure: mg/dL	Baseline (Day 1) to Day 365
Complications	From patient medical records or self-reported. Unit of measure: Incidence and type of complications (qualitative data)	Baseline (Day 1) to Day 365
Physical activity levels	From wearable device. Unit of measure: minutes of moderate to vigorous activity per day.	Baseline (Day 1) to Day 300
Sleep quality	From wearable device. Unit of measure: Sleep score or duration and quality of sleep (hours and sleep stages).	Baseline (Day 1) to Day 300
Heart rate	From wearable device. Unit of measure: average resting heart rate (beats per minute).	Baseline (Day 1) to Day 300
6-minute walk test performance	Standardized 6-minute walk test. Unit of measure: distance covered in meters.	Baseline (Day 1) to Day 365
System Usability	Measures the perceived usability of ACDP. Minimum Value: 0. Maximum Value: 10. Interpretation: Higher scores indicate better perceibed usability	Day 150 to 300

Collaborators and Investigators

• Sponsor: Adhera Health, Inc.
• Collaborators: University of Valencia; University of Seville; Hospital Universitario Miguel Servet, Zaragoza

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2025
• Primary Completion (Actual): March 19, 2026
• Study Completion (Actual): May 19, 2026

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Digital health; Treatment satisfaction; pharmacological treatment for obesity
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Pediatric Obesity; Therapeutics; Diagnostic Techniques and Procedures; Diagnosis; Physiological Phenomena; Biochemical Phenomena; Chemical Phenomena; Physical Examination; Body Weights and Measures; Body Constitution; Metabolism; Body Fat Distribution; Body Composition; Drug Therapy; Adiposity; 2-amino-3-cyano-6-methyl-5-(3,4-dimethoxyphenyl)pyridine
• Other Study ID Numbers: DAL-CLI-24-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No