DAta-driven PersonaLIzation of a DigitAl Health Solution to Support Family Caregivers of Children with Chronic Conditions
- Conditions
- Obesity, Childhood
- Interventions
- Combination Product: ACDP® and Semaglutide
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intervention group ACDP® and Semaglutide 40 Families of children with obesity willing to join a combined intervention (ACDP® and Semaglutide). After the recruitment, the family will join Adhera Caring Digital Program® for 13 months. Semaglutide treatment will start one month after joining the digital intervention.
- 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 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
Blood pressure Baseline (Day 1) to Day 365 Standard pressure measurement. Unit of measure: mmHg.
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.
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.