obesity, chronic fatigue asthma cystic fibrosis fatigue severe overweight sickle cell disease
Conditions
Interventions
None listed
Sponsors
Centre for Human Drug Research
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: General 1. Signed informed consent from both parents or the legal guardian prior to any study-mandated procedure and from subjects aged older than 11 years old. 2. Patients undergoing treatment by a pediatrician 3. Age 6-16 years for subjects in arm A, B and D. Age 5-17 for subjects in arm C., Arm A. - Patients are referred by their general practitioner due to complaints of general malaise, fatigue or tiredness. Arm B. - Patients are diagnosed with obesity Arm C. - Patients are diagnosed with sickle cell disease Arm D. - Patients are treated for cystic fibrosis or - Patients have controlled or difficult to control asthma at the time of inclusion. o Difficult to control asthma defined by Asthma Control Questionnaire cutoff score of 1.5 or fulfilling * 3 Global Initiative for Asthma (GINA) criteria for partly/uncontrolled asthma
Exclusion criteria
Exclusion criteria: 1. Evidence or history of lung disease, cardiac disease, neuromuscular disease, diabetes (excluding: CF-associated diabetes in arm D, diabetes type 2 associated with obesity in arm B) or any other chronic condition other than the studied disease, that might impair activity level. 2. Children that have a mental and/or motor impairment. 3. Inability to wear or use the wearable device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Daily physical activity level (step count) | — |
Secondary
| Measure | Time frame |
|---|---|
| Baseline information Baseline questionnaires: Arm A: Pediatric Quality of Life Inventory (PedsQL) 4.0, pedsQL multidimensional fatigue scale, Pediatric Functional Assessment of Chronic Illness Therapy-Fatigue (peds-FACIT-F), Revised Children*s Anxiety and Depression Scale (RCADS), Children's Somatization Inventory (CSI), PROMIS pediatric pain Arm B: pedsQL 4.0, CSI, RCADS Arm C: pedsQL 4.0, pedsQL pain quality, PROMIS Pediatric pain, Arm D: pedsQL 4.0, modified standardized pediatric asthma quality of life questionnaire (MPAQLQ(S)), modified asthma control questionnaire (MACQ), cystic fibrosis questionnaire (CFQ), respiratory symptom scores Sleep: Hours of sleep, time deep sleep, time shallow sleep Heart rate: Mean heart rate, max heart rate, min heart rate Weight and body composition (bioimpedance analysis): Arm A: baseline and end-of-study weight and body composition Arm B: weekly weight and body composition Symptom scores via smartphone app: Arm A: Daily: fatigue score, sleep quality score, self-reported activity score, parent reported activity score, screen time score. Weekly: peds-FACIT-F, PROMIS Pediatric pain Arm B: Daily: self-reported activity score, parent-reported activity score, screen time score, sleep quality score Arm C: Daily: pain intensity score, pain limits activity score, number of painful areas, parent-reported activity score, self-reported activity score, screen time score, sleep quality score. Weekly: PROMIS Pediatric pain Arm D: Daily: asthma control diary (subjects with asthma only), respiratory symptom scores (subjects with cystic fibrosis only), parent-reported activity, self-reported activity, screen time score, sleep quality score Daily environmental data: Arm C: local air quality (NO2, NO, O3, PM10, PM2.5), weather conditions (mean temperature, max temperature, min temperature, mean wind speed, mean air humidity, sun exposure duration, amount of rain) Arm D: local air quality, pollen count, weather con | — |
Countries
Netherlands
Outcome results
None listed