An interventional study of Lifestyle-change intervention in Asthma (Diagnosis), sponsored by Universitat Internacional de Catalunya. Not yet recruiting. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Universitat Internacional de Catalunya · Not applicable, Interventional, and Treatment
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:
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:
Asthma is one of the most common chronic diseases in adolescence and can negatively affect health-related quality of life, asthma control, adherence to movement behaviours, and psychosocial well-being. Adolescents with poorer health-related quality of life may face difficulties achieving recommended levels of physical activity, limiting recreational screen time, maintaining adequate sleep duration, controlling asthma, and managing the psychological and social challenges.
CLiQ-Asthma is a multicenter randomised controlled trial designed to evaluate the impact of a multicomponent lifestyle intervention in adolescents with asthma and lower health-related quality of life. The intervention aims to improve health-related quality of life, asthma control, movement behaviours adherence, and psychosocial outcomes. Participants will be assessed at baseline, after 3 months of intervention, and after 3 months of follow-up.
The intervention includes three main components. First, participants will follow an individualised goal-setting program to improve adherence to the Canadian 24-H Movement Guidelines, supported by smartwatch monitoring. Second, participants will attend online group educational sessions tailored according to age and asthma severity. Third, motivational strategies will be used to support engagement and sustain participation throughout the intervention period. The comparison group will receive usual care.
In addition to evaluating the effectiveness of the intervention, the study will examine whether sex and asthma severity moderate intervention effects.
Moreover, an embedded realist evaluation will be conducted to explain possible heterogeneity in intervention effectiveness. This evaluation will explore what works, for whom, in which circumstances, and why, by integrating quantitative and qualitative data to refine the program theory and inform future implementation.
4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.
This study's planned enrollment of 96 is above the median of 83 across 2,814 interventional studies indexed under Asthma.
Browse Asthma studies →Universitat Internacional de Catalunya is the lead sponsor of 150 studies on the registry; 45 are open to participants now.
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Exclusion Criteria:
Participants assigned to this group will receive a 12-week remote multicomponent lifestyle-change intervention in addition to usual asthma care and routine follow-up with their treating clinicians. The intervention includes an individualised goal-setting programme supported by smartwatch monitoring, online small-group educational sessions tailored by age and asthma severity, and motivational follow-up strategies such as reminders and digital feedback. They will continue receiving their usual asthma care and routine follow-up from their treating clinicians.
Behavioral: Lifestyle-change intervention
Participants assigned to this group will continue receiving usual asthma care and routine follow-up from their treating clinicians.
A 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.
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.
Time frame: At baseline, at 3 months (post-intervention) and at 6 months (follow-up).
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).
Time frame: At baseline, at 3 months (post-intervention) and at 6 months (follow-up).
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.
Time frame: At baseline, at 3 months (post-intervention) and at 6 months (follow-up).
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.
Time frame: At baseline, at 3 months (post-intervention) and at 6 months (follow-up).
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.
Time frame: At baseline, at 3 months (post-intervention) and at 6 months (follow-up).
Sedentary behaviour
Sedentary behaviour will be evaluated using the Youth Leisure-Time Sedentary Behaviour Questionnaire (YLTSBQ). Higher values indicate more minutes spent on sedentary behaviour.
Time frame: At baseline, at 3 months (post-intervention) and at 6 months (follow-up).
Sleep duration
Sleep duration will be evaluated using smartwatch-derived total sleep time.
Time frame: At baseline, at 3 months (post-intervention) and at 6 months (follow-up).
Perceived asthma self-efficacy
Asthma self-efficacy will be evaluated using the Adolescent Asthma Self-Efficacy Questionnaire (AASEQ). Higher scores indicate greater perceived self-efficacy for asthma management.
Time frame: At baseline, at 3 months (post-intervention) and at 6 months (follow-up).
Perceived social support
Perceived social support will be evaluated using the Multidimensional Scale of Perceived Social Support (MSPSS). Higher scores indicate greater perceived social support.
Time frame: At baseline, at 3 months (post-intervention) and at 6 months (follow-up).
Anxiety and depressive symptoms
Anxiety and depressive symptoms will be evaluated using the Hospital Anxiety and Depression Scale (HADS). Higher scores indicate greater symptom severity.
Time frame: At baseline, at 3 months (post-intervention) and at 6 months (follow-up).
Asthma exacerbations
Number of asthma exacerbations per participant, obtained from clinical records and recorded as a count. Exacerbations are compared between the intervention and usual care groups.
Time frame: During the 12-week intervention and up to the 6-month follow-up.
Emergency room visits
Number of asthma-related emergency room (ER) visits per participant, obtained from clinical records and recorded as a count. ER visits are compared between the intervention and usual care groups.
Time frame: During the 12-week intervention and up to the 6-month follow-up.
Changes in asthma medication
Changes in asthma medication, obtained from clinical records and recorded as a nominal categorical variable (step-up, step-down, or no change in the controller regimen). Categories are compared between the intervention and usual care groups.
Time frame: During the 12-week intervention and up to the 6-month follow-up.
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.
Time frame: During the 12-week intervention.
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.
Time frame: During the 12-week intervention.
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.
Time frame: During the 12-week intervention.
Retention
Retention will be evaluated as the proportion of participants who complete the intervention and follow-up assessments. Higher values indicate greater retention.
Time frame: At 3 months (post-intervention) and 6 months (follow-up).
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — An anonymized individual participant dataset underlying the reported trial results will be shared. The shared dataset will exclude direct identifiers and any information considered to present an unacceptable risk of participant re-identification.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: After completion of study, the data will be stored for as long as necessary to meet any possible responsibilities derived from the study.
Access criteria: Anonymized IPD and supporting materials will be shared via Zenodo after assessment of re-identification risk. If adequate anonymization cannot be ensured, only aggregate data or controlled access to individual-level data will be provided.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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