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| Name | Class |
|---|---|
| Hospital Universitario Miguel Servet, Zaragoza | UNKNOWN |
| University of Valencia | OTHER |
| University of Seville | OTHER |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Miguel Servet | Zaragoza | Aragon | 50009 | Spain |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C067723 | 2-amino-3-cyano-6-methyl-5-(3,4-dimethoxyphenyl)pyridine |
| D004358 | Drug Therapy |
| D050154 | Adiposity |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D050218 | Body Fat Distribution |
| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
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| 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 |
| 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 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010808 |
| Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D001823 | Body Composition |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D008660 | Metabolism |
| D010829 | Physiological Phenomena |