DAta-driven personaLIzation of a digitAl Health Solution to Support Family Caregivers of Children With Chronic Conditions
NCT Number: NCT06520787
Acronym: DALIA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity, Childhood
Interventions: COMBINATION_PRODUCT: ACDP® and Semaglutide
Sponsor: Adhera Health, Inc.
Collaborators: Hospital Miguel Servet|University of Valencia|University of Seville
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-10
Completion Date: 2026-09

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 (Semaglutide in combination with the Adhera Caring Digital Program®) on treatment satisfaction, adherence, and mood. The main questions it aims to answer are:

* Does the combination of Semaglutide and the Adhera Caring Digital Program® improve treatment satisfaction, adherence, and mood in families of children with obesity compared to the standard of care?
* What are the emotional and health-related quality of life outcomes for children and their families using the combined treatment versus the standard of care?

Researchers will compare the intervention group (using the Adhera Caring Digital Program® with Semaglutide) to the control group (standard of care without digital or pharmacological intervention) to see if there is a significant difference in the primary and secondary outcomes.

Participants will:

* Use the Adhera Caring Digital Program® (ACDP®) for obesity, which includes digital therapeutic software, personalized messages, and educational materials.
* Take Semaglutide 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.

Primary Outcome Measures: Treatment satisfaction, Treatment satisfaction measured Treatment Satisfaction Questionnaire for Medication (TSQM). Minimum Value: 0. Maximum Value: 100. Interpretation: Higher scores indicate better outcomes (greater treatment satisfaction)., Day 30 to Day 518|Treatment adherence 1, Treatment adherence measured by injection registry (self-reported). Unit of Measure: Frequency of injections., Day 30 to Day 518|Treatment adherence 2, Treatment adherence measured by changes in nutritional compliance (self-reported). Unit of measure: Description of diet (qualitative data)., Day 30 to Day 518|Treatment adherence 3, Treatment adherence measured by discontinuation (and reasons behind it). Unit of measure: Incidence of discontinuation with categorized reasons., Day 30 to Day 518
Secondary Outcome Measures: 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). Minimum Value: 0. Maximum Value: 63. Interpretation: Higher scores indicate worse outcomes (greater levels of depression, anxiety, and stress)., Baseline (Day 1) to Day 518|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 518|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 518|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 518|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 518|Height, From bioimpedance scale. Standard medical measurement. Unit of measure: meters., Baseline (Day 1) to Day 518|Weight, From bioimpedance scale. Standard medical measurement. Unit of measure: kilograms., Baseline (Day 1) to Day 518|Body Mass Index (BMI), From bioimpedance scale. Calculated from height and weight. Unit of measure: kg/m², Baseline (Day 1) to Day 518|Blood pressure, Standard pressure measurement. Unit of measure: mmHg., Baseline (Day 1) to Day 518|Time since diagnosis, From patient medical records or self-reported data. Unit of measure: weeks, months or years., Baseline (Day 1) to Day 518|Previous obesity treatments, From patient medical records and self-reported data. Unit of measure: Description of treatment (qualitative data)., Baseline (Day 1) to Day 518|Cholesterol levels, Blood test results. Unit of measure: mg/dL, Baseline (Day 1) to Day 518|Complications, From patient medical records or self-reported. Unit of measure: Incidence and type of complications (qualitative data), Baseline (Day 1) to Day 518|Step count, From wearable device. Unit of measure: number of steps per day., Baseline (Day 1) to Day 396|Physical activity levels, From wearable device. Unit of measure: minutes of moderate to vigorous activity per day., Baseline (Day 1) to Day 396|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 396|Heart rate, From wearable device. Unit of measure: average resting heart rate (beats per minute)., Baseline (Day 1) to Day 396|6-minute walk test performance, Standardized 6-minute walk test. Unit of measure: distance covered in meters., Baseline (Day 1) to Day 396