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

Not Applicable

Active, not recruiting

• Conditions: Obesity, Childhood

• Registration Number: NCT06520787
• Lead Sponsor: Adhera Health, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-04
• Study First Submitted QC: 2024-07-19
• Study First Posted: 2024-07-25
• Study Start: 2025-03-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-29
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment satisfaction	Day 1 to Day 365	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).
Treatment adherence 1	Day 1 to Day 365	Treatment adherence measured by injection (self-reported). Unit of measure: Number of injections (quantitative data)
Treatment adherence 2	Day 1 to Day 365	Treatment adherence measured by changes in nutritional compliance (self-reported). Unit of measure: Description of diet (qualitative data).
Treatment adherence 3	Day 150 to Day 365	Treatment adherence measured by discontinuation (and reasons behind it). Unit of measure: Incidence of discontinuation with categorized reasons.

Secondary Outcome Measures

Name	Time	Method
Emotional outcome 1	Baseline (Day 1) to Day 365	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).
Emotional outcome 2	Baseline (Day 1) to Day 365	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).
Emotional outcome 3	Baseline (Day 1) to Day 365	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).
Health-related Quality of Life (HrQoL)	Baseline (Day 1) to Day 365	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).
Levels of physical activity	Baseline (Day 1) to Day 365	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).
Height	Baseline (Day 1) to Day 365	From bioimpedance scale. Standard medical measurement. Unit of measure: meters.
Weight	Baseline (Day 1) to Day 365	From bioimpedance scale. Standard medical measurement. Unit of measure: kilograms.
Body Mass Index (BMI)	Baseline (Day 1) to Day 365	From bioimpedance scale. Calculated from height and weight. Unit of measure: kg/m²
Time since diagnosis	Baseline (Day 1) to Day 365	From patient medical records or self-reported data. Unit of measure: weeks, months or years.
Previous obesity treatments	Baseline (Day 1) to Day 365	From patient medical records and self-reported data. Unit of measure: Description of treatment (qualitative data).
Cholesterol levels	Baseline (Day 1) to Day 365	Blood test results. Unit of measure: mg/dL
Complications	Baseline (Day 1) to Day 365	From patient medical records or self-reported. Unit of measure: Incidence and type of complications (qualitative data)
Step count	Baseline (Day 1) to Day 396	From wearable device. Unit of measure: number of steps per day.
Physical activity levels	Baseline (Day 1) to Day 300	From wearable device. Unit of measure: minutes of moderate to vigorous activity per day.
Sleep quality	Baseline (Day 1) to Day 300	From wearable device. Unit of measure: Sleep score or duration and quality of sleep (hours and sleep stages).
Heart rate	Baseline (Day 1) to Day 300	From wearable device. Unit of measure: average resting heart rate (beats per minute).
6-minute walk test performance	Baseline (Day 1) to Day 365	Standardized 6-minute walk test. Unit of measure: distance covered in meters.
Blood pressure	Baseline (Day 1) to Day 365	Standard pressure measurement. Unit of measure: mmHg.

Trial Locations

Locations (1)

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Aragón, Spain