About this trial
The goal of this clinical trial is to evaluate if a multicomponent lifestyle intervention can improve health-related quality of life in adolescents with asthma. The main questions it aims to answer are:
* Does the intervention improve health-related quality of life? * Does the intervention improve asthma control, movement behaviours adherence, and psychosocial outcomes?
Researchers will compare a multicomponent intervention group to a usual care group to see if the intervention improves health-related quality of life and asthma control, movement behaviours adherence, and psychosocial outcomes.
Participants will:
* Complete assessments at baseline, after 3 months of intervention, and after 3 months of follow-up. * Answer questionnaires about health-related quality of life, asthma control, movement behaviours, and psychosocial factors. * Be assigned to either the intervention group or the usual care group. * Receive, if assigned to the intervention group, individualised goals program supported by a smartwatch, online group educational sessions, and motivational strategies to support participation and behaviour change.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adolescents aged 13 to 17 years.
Confirmed diagnosis of asthma according to GINA 2024 criteria (any severity).
No asthma exacerbations during the 3 weeks before enrollment.
Ongoing hospital follow-up for asthma.
Disqualifiers
Medical conditions other than asthma that could affect movement behaviours, psychosocial factors, or health-related quality of life.
Psychiatric conditions that could affect movement behaviours, psychosocial factors, or health-related quality of life.
Cognitive conditions that could affect movement behaviours, psychosocial factors, or health-related quality of life.
Use of medication not related to asthma that could affect movement behaviours, psychosocial factors, or health-related quality of life.
Trial design
Parallel
Treatments tested in this trial
Lifestyle-change intervention
BehavioralA 12-week remote multicomponent lifestyle-change intervention based on an individualised goal-setting program, smartwatch-supported self-monitoring, online small-group educational sessions, and motivational follow-up strategies. The intervention is designed to improve health-related quality of life by promoting better asthma control, psychosocial well-being, and adherence to movement behaviour recommendations, including physical activity, recreational screen time, and sleep duration.
Treatment groups
Trial outcomes
Primary outcomes
Health-related quality of life
Health-related quality of life will be evaluated using the Pediatric Quality of Life Inventory Asthma Module (PedsQL-Asthma), a self-reported questionnaire. Scores are transformed to a 0 to 100 scale, with higher scores indicating better health-related quality of life.
Secondary outcomes
Asthma control
Asthma control will be evaluated using the Asthma Control Test (ACT), a self-reported questionnaire. Higher scores indicate better asthma control. Scores are classified as controlled (≥21), partly controlled (19-20), and uncontrolled (≤18).
Adherence to movement behaviour recommendations
Adherence to the movement behaviour recommendations will be evaluated as the number of guidelines met (0, 1, 2, or 3) across physical activity, recreational screen time, and sleep duration. Physical activity adherence will be defined as ≥60 min/day of moderate-to-vigorous physical activity or ≥9701 steps/day. Sedentary behaviour adherence will be defined as ≤2 h/day of recreational screen time. Sleep adherence will be defined as 8-10 h/night.
Daily step count
Mean number of steps per day recorded by a wrist-worn smartwatch worn 24 hours/day during a 7-day monitoring period at each assessment. Only valid recordings (at least 5 days with at least 20 hours/day of data) will be included. Higher values indicate more physical activity.
Daily time in moderate-to-vigorous physical activity
Mean minutes per day of moderate-to-vigorous physical activity recorded by a wrist-worn smartwatch worn 24 hours/day during a 7-day monitoring period at each assessment. Only valid recordings (at least 5 days with at least 20 hours/day of data) will be included. Higher values indicate more physical activity.
Other outcomes
Session attendance
Session attendance will be recorded as the percentage of scheduled online educational sessions attended during the intervention period. Higher values indicate greater participation.
Goal attainment
Goal attainment will be recorded as the percentage of weeks in which individualised weekly goals are achieved during the intervention period. Higher values indicate greater adherence to the intervention goals.
Smartwatch adherence
Adherence to smartwatch use will be recorded as the percentage of valid monitoring days during the intervention period. Valid monitoring will require at least 5 days with at least 20 hours/day of recorded data. Higher values indicate greater adherence to smartwatch use.
Retention
Retention will be evaluated as the proportion of participants who complete the intervention and follow-up assessments. Higher values indicate greater retention.
Locations
Sponsors and contacts
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