[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660049":3},{"organization":4,"outcomesModule":7,"designInfo":66,"detailedDescription":78,"studyPopulation":71,"armGroups":79,"interventions":90,"overallOfficials":96,"centralContacts":100,"locations":71,"responsibleParty":106,"collaborators":71,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":111,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":71,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":140,"whyStopped":71,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":71},{"fullName":5,"class":6},"Universitat Internacional de Catalunya","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":51},[9],{"measure":10,"description":11,"timeFrame":12},"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.","At baseline, at 3 months (post-intervention) and at 6 months (follow-up).",[14,17,20,23,26,29,32,35,38,41,45,48],{"measure":15,"description":16,"timeFrame":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).",{"measure":18,"description":19,"timeFrame":12},"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\u002Fday of moderate-to-vigorous physical activity or ≥9701 steps\u002Fday. Sedentary behaviour adherence will be defined as ≤2 h\u002Fday of recreational screen time. Sleep adherence will be defined as 8-10 h\u002Fnight.",{"measure":21,"description":22,"timeFrame":12},"Daily step count","Mean number of steps per day recorded by a wrist-worn smartwatch worn 24 hours\u002Fday during a 7-day monitoring period at each assessment. Only valid recordings (at least 5 days with at least 20 hours\u002Fday of data) will be included. Higher values indicate more physical activity.",{"measure":24,"description":25,"timeFrame":12},"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\u002Fday during a 7-day monitoring period at each assessment. Only valid recordings (at least 5 days with at least 20 hours\u002Fday of data) will be included. Higher values indicate more physical activity.",{"measure":27,"description":28,"timeFrame":12},"Sedentary behaviour","Sedentary behaviour will be evaluated using the Youth Leisure-Time Sedentary Behaviour Questionnaire (YLTSBQ).",{"measure":30,"description":31,"timeFrame":12},"Sleep duration","Sleep duration will be evaluated using smartwatch-derived total sleep time.",{"measure":33,"description":34,"timeFrame":12},"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.",{"measure":36,"description":37,"timeFrame":12},"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.",{"measure":39,"description":40,"timeFrame":12},"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.",{"measure":42,"description":43,"timeFrame":44},"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.","During the 12-week intervention and up to the 6-month follow-up.",{"measure":46,"description":47,"timeFrame":44},"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.",{"measure":49,"description":50,"timeFrame":44},"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.",[52,56,59,62],{"measure":53,"description":54,"timeFrame":55},"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.","During the 12-week intervention.",{"measure":57,"description":58,"timeFrame":55},"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.",{"measure":60,"description":61,"timeFrame":55},"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\u002Fday of recorded data. Higher values indicate greater adherence to smartwatch use.",{"measure":63,"description":64,"timeFrame":65},"Retention","Retention will be evaluated as the proportion of participants who complete the intervention and follow-up assessments. Higher values indicate greater retention.","At 3 months (post-intervention) and 6 months (follow-up).",{"allocation":67,"interventionModel":68,"interventionModelDescription":69,"primaryPurpose":70,"observationalModel":71,"timePerspective":71,"maskingInfo":72},"RANDOMIZED","PARALLEL","Multicenter study, randomized controlled trial in two parallel groups (ratio 1:1), double blinded.","TREATMENT",null,{"masking":73,"maskingDescription":74,"whoMasked":75},"DOUBLE","The evaluators and care providers will be masked to the allocation of the patients. Given the nature of the intervention, participants and intervention providers cannot be masked to group allocation.",[76,77],"CARE_PROVIDER","OUTCOMES_ASSESSOR","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.\n\nCLiQ-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.\n\nThe 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.\n\nIn addition to evaluating the effectiveness of the intervention, the study will examine whether sex and asthma severity moderate intervention effects.\n\nMoreover, 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.",[80,86],{"label":81,"type":82,"description":83,"interventionNames":84},"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.\n\nThey will continue receiving their usual asthma care and routine follow-up from their treating clinicians.",[85],"Behavioral: Lifestyle-change intervention",{"label":87,"type":88,"description":89,"interventionNames":71},"Control group","NO_INTERVENTION","Participants assigned to this group will continue receiving usual asthma care and routine follow-up from their treating clinicians.",[91],{"type":92,"name":93,"description":94,"armGroupLabels":95,"otherNames":71},"BEHAVIORAL","Lifestyle-change intervention","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.",[81],[97],{"name":98,"affiliation":5,"role":99},"Marcio VF Donadio, PhD","PRINCIPAL_INVESTIGATOR",[101],{"name":98,"role":102,"phone":103,"phoneExt":104,"email":105},"CONTACT","+34 93 504 20 00","5370","mdonadio@uic.es",{"type":99,"investigatorFullName":107,"investigatorTitle":108,"investigatorAffiliation":5,"oldNameTitle":71,"oldOrganization":71},"Márcio Vinícius Fagundes Donadio","Full Professor","100660049","changing-lifestyle-to-improve-quality-of-life-in-spanish-adolescents-with-asthma-100660049",false,"NCT07870980","Changing Lifestyle to Improve Quality of Life in Spanish Adolescents With Asthma","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","CLiQ-Asthma","Inclusion Criteria:\n\n* Adolescents aged 13 to 17 years.\n* Confirmed diagnosis of asthma according to GINA 2024 criteria (any severity).\n* No asthma exacerbations during the 3 weeks before enrollment.\n* Ongoing hospital follow-up for asthma.\n* Stable asthma treatment at the time of enrollment.\n* Able to speak and understand Spanish.\n* No physical limitations that affect participation in physical activity.\n* Low health-related quality of life.\n* Access to a compatible mobile device for study participation.\n\nExclusion Criteria:\n\n* Medical conditions other than asthma that could affect movement behaviours, psychosocial factors, or health-related quality of life.\n* Psychiatric conditions that could affect movement behaviours, psychosocial factors, or health-related quality of life.\n* Cognitive conditions that could affect movement behaviours, psychosocial factors, or health-related quality of life.\n* Use of medication not related to asthma that could affect movement behaviours, psychosocial factors, or health-related quality of life.\n* Current participation in another research study.","ALL","13 Years","17 Years",{"count":121,"type":122},96,"ESTIMATED","INTERVENTIONAL",[125],"NA","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:\n\n* Does the intervention improve health-related quality of life?\n* Does the intervention improve asthma control, movement behaviours adherence, and psychosocial outcomes?\n\nResearchers 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.\n\nParticipants will:\n\n* Complete assessments at baseline, after 3 months of intervention, and after 3 months of follow-up.\n* Answer questionnaires about health-related quality of life, asthma control, movement behaviours, and psychosocial factors.\n* Be assigned to either the intervention group or the usual care group.\n* 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.",[128],"Asthma (Diagnosis)",[130,131,132,133,134,135,136,137,138,139],"adolescents","non-pharmacological intervention","lifestyle","physical activity","quality of life","remote monitoring","health promotion","behaviour change","sleep","sedentary behaviour","NOT_YET_RECRUITING","2026-10-06",{"date":143,"type":144},"2026-10-13","ACTUAL",{"date":146,"type":122},"2026-11-02",{"date":148,"type":122},"2027-12-20",{"name":5,"class":6}]