Changing Lifestyle to Improve Quality of Life in Spanish Adolescents With Asthma

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.

• Lifestyle-change intervention (Behavioral): 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.

Primary outcomes

• Health-related quality of life [At baseline, at 3 months (post-intervention) and at 6 months (follow-up).]: 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 [At baseline, at 3 months (post-intervention) and at 6 months (follow-up).]: 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 [At baseline, at 3 months (post-intervention) and at 6 months (follow-up).]: 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 [At baseline, at 3 months (post-intervention) and at 6 months (follow-up).]: 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 [At baseline, at 3 months (post-intervention) and at 6 months (follow-up).]: 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.
• Sedentary behaviour [At baseline, at 3 months (post-intervention) and at 6 months (follow-up).]: Sedentary behaviour will be evaluated using the Youth Leisure-Time Sedentary Behaviour Questionnaire (YLTSBQ). Higher values indicate more minutes spent on sedentary behaviour.
• Sleep duration [At baseline, at 3 months (post-intervention) and at 6 months (follow-up).]: Sleep duration will be evaluated using smartwatch-derived total sleep time.
• Perceived asthma self-efficacy [At baseline, at 3 months (post-intervention) and at 6 months (follow-up).]: Asthma self-efficacy will be evaluated using the Adolescent Asthma Self-Efficacy Questionnaire (AASEQ). Higher scores indicate greater perceived self-efficacy for asthma management.
• Perceived social support [At baseline, at 3 months (post-intervention) and at 6 months (follow-up).]: Perceived social support will be evaluated using the Multidimensional Scale of Perceived Social Support (MSPSS). Higher scores indicate greater perceived social support.
• Anxiety and depressive symptoms [At baseline, at 3 months (post-intervention) and at 6 months (follow-up).]: Anxiety and depressive symptoms will be evaluated using the Hospital Anxiety and Depression Scale (HADS). Higher scores indicate greater symptom severity.
• Asthma exacerbations [During the 12-week intervention and up to the 6-month follow-up.]: 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.
• Emergency room visits [During the 12-week intervention and up to the 6-month follow-up.]: 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.
• Changes in asthma medication [During the 12-week intervention and up to the 6-month follow-up.]: 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.

Other outcomes

• Session attendance [During the 12-week intervention.]: 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 [During the 12-week intervention.]: 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 [During the 12-week intervention.]: 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 [At 3 months (post-intervention) and 6 months (follow-up).]: Retention will be evaluated as the proportion of participants who complete the intervention and follow-up assessments. Higher values indicate greater retention.

Sex: All, ages: 13 Years to 17 Years

Inclusion Criteria:

* 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.
* Stable asthma treatment at the time of enrollment.
* Able to speak and understand Spanish.
* No physical limitations that affect participation in physical activity.
* Low health-related quality of life.
* Access to a compatible mobile device for study participation.

Exclusion Criteria:

* 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.
* Current participation in another research study.

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form (PDF, 2026-10-06)

• Marcio VF Donadio, PhD, Principal investigator, Universitat Internacional de Catalunya