Asthma (Diagnosis)CLiQ-AsthmaNCT07870980
Changing Lifestyle to Improve Quality of Life in Spanish Adolescents With Asthma
A study testing Lifestyle-change intervention in people with Asthma (Diagnosis), run by Universitat Internacional de Catalunya.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Asthma (Diagnosis)
- What is being tested?
- Lifestyle-change intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2026to 20 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- No physical limitations that affect participation in physical activity.
- Low health-related quality of life.
- Access to a compatible mobile device for study participation.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Changing Lifestyle to Improve Quality of Life in Spanish Adolescents With Asthma (CLiQ-Asthma): the Influence of Asthma Control and Severity, Movement Behaviours, Psychosocial Factors, and Sex Differences
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Asthma (Diagnosis)
- Being tested
- Lifestyle-change intervention
- Keywords
- adolescents, non-pharmacological intervention, lifestyle, physical activity, quality of life, remote monitoring, health promotion, behaviour change, sleep, sedentary behaviour
- Medical subject headings
- Asthma, Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle-change interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent lifestyle-change intervention + usual care | Experimental | 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. Receives: Behavioral: Lifestyle-change intervention |
| Control group | No intervention | Participants assigned to this group will continue receiving usual asthma care and routine follow-up from their treating clinicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, at 3 months (post-intervention) and at 6 months (follow-up).
Secondary outcomes (12)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the 12-week intervention and up to the 6-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start2 Nov 2026 (estimated)
- Primary completion20 Dec 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter study, randomized controlled trial in two parallel groups (ratio 1:1), double blinded.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Márcio Vinícius Fagundes Donadio, Universitat Internacional de Catalunya
- Investigators
- Marcio VF Donadio, PhD, Principal investigator, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870980
- Sponsor's protocol ID
- CLiQ-Asthma-UIC
- Acronym
- CLiQ-Asthma
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.