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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorUniversitat Internacional de Catalunya

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Multicomponent lifestyle-change intervention + usual careExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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).

Secondary outcomes

1

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).
2

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).
3

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).
4

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).

Other outcomes

1

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.
2

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.
3

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.
4

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).

Locations

This trial has no locations.

Sponsors and contacts

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