Asthma in ChildrenMATADORSNCT05742646
Managing AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study
A study testing MATADORS in people with Asthma in Children and Obesity, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this 4 week pilot study is to test the use of a mobile application (also commonly referred to as an app) designed to help increase self-management strategies among youth that have asthma and obesity. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children, Obesity, Obesity, Adolescent
- What is being tested?
- MATADORS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2022to 29 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Youth-Caregiver Dyad Inclusion Criteria:
- Male and female youth aged 10 - 17 years
- Adult primary caregiver (18 years and older)
- English speaking
- Youth diagnosis of asthma
- Prescribed inhaler treatment for asthma
Show all 9Show fewer
- Youth Body Mass Index at or above the 85th percentile for age and sex based on the Centers for Disease Control (CDC) growth charts
- Must own a smartphone (iOS) with working Wi-Fi access and/or cellular data plan
- Prescribed inhaler treatment for asthma
Who cannot join
- Diagnosis of cognitive impairment
- Inability or unwillingness of youth participant to assent and/or primary caregiver/legal guardian/representative to give informed consent
- Inability or unwillingness to participate in the audio recording interview session or complete study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Managing AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study: An mHealth Intervention to Facilitate Symptom Self-management Among Youth
The purpose of this 4 week pilot study is to test the use of a mobile application (also commonly referred to as an app) designed to help increase self-management strategies among youth that have asthma and obesity. The data obtained from this study will facilitate refinement of the app and interventional approaches for a future larger scale study to increase youth self-management of their clinical conditions, symptom management, and health maintenance as they transition to adulthood.
Read the detailed description
Investigate the feasibility of a 4-week evidence-based, nurse-guided, mHealth self-management intervention application for youth with asthma and obesity (ages 10-17).
Aims are to conduct feasibility testing of the app with a sample of youth randomized to the intervention or control and to obtain estimates of variability and describe preliminary outcomes of the application on fatigue, pain, self-efficacy, anxiety, sleep, depression, and quality of life measured at baseline, 4, and 8 weeks.
- Conditions
- Asthma in Children, Obesity, Obesity, Adolescent, Obesity, Childhood
- Being tested
- MATADORS, MATADORS Control
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MATADORSBehavioural
Youth will have access to the MATADORS app to include basic information and expanded educational features. They will be asked to log into the app daily for one month and they will be asked to report within the app how they are feeling each day and their medications taken.
MATADORS ControlBehavioural
Youth will have access to the MATADORS app basic information. They will be asked to log into the app daily for one month and they will be asked to report within the app their medications taken.
| Study group | Role | What they receive |
|---|---|---|
| MATADORS app basic information | Active comparator | The basic app includes real-time symptom monitoring through ecological momentary assessment (EMA) and medication adherence. Basic SMS text messages are sent to participants with reminders to complete EMA questions and enter medication taken. Participants also are provided with activity trackers to assess physical activity and sleep patterns. Receives: Behavioral: MATADORS Control |
| MATADORS app to include basic information and expanded educational features | Experimental | Participants in the experimental arm have access to the basic app, along with educational and resource-specific information on asthma, obesity, medications, symptom management, and lifestyle modifications. Features include images, text, and video content. Participants in the experimental arm also are provided with activity trackers to assess physical activity and sleep patterns. Receives: Behavioral: MATADORS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Completing 4-week Study Period
Participant retention and feasibility in completing the 4-week study
Measured: 4-week study period
Secondary outcomes (15)
Loss to Follow-up
Number of participants lost to follow-up
Measured: 8 weeks
Study Withdrawals
Number of participants who self withdrew from the study
Measured: 8 weeks
End of Study Dyadic Interviews
Number of completed end of study dyadic interviews
Measured: 8 weeks
Change in Fatigue
Change in Fatigue (measured by PROMIS Pediatric Fatigue)-Self-report of fatigue symptoms ranging from tiredness to overwhelming exhaustion. Low score indicates a low level of fatigue and a high score may represent extreme or debilitating levels of exhaustion. Scores above 65 suggest severe fatigue, 55-64 suggest moderate fatigue, 50-54 suggest mild fatigue, and scores less than 50 suggest fatigue scores that are within normal limits (with the lower the number representing healthier rates). 50 indicates the population mean with a standard deviation of 10
Measured: 8 weeks
Change in Self-Efficacy
Change in Self-Efficacy (measured by Change in Self-Efficacy for Managing Chronic Disease-6 item scale). This is a 6-item instrument reported on an analog scale that highlights one's confidence in managing their chronic disease. Each item ranges from 1 (minimum; not confident at all) to 10 (maximum; extremely confident). Overall total scores range from 6-60. Minimum total score = 6 and maximum total score = 60. The higher the total score indicates the higher or better level of self-efficacy.
Measured: 8 weeks
Change in Asthma Control
Change in asthma control (measured by Asthma Control Test). Scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.
Measured: 8 weeks
Physical Activity Patterns
Number of minutes active per day
Measured: Weekly for 6 weeks (weeks 1-6)
Medication Adherence
Self-report of rescue and/or controller medication usage
Measured: Daily for 28 days
Symptom Reporting
Number of days reporting symptoms of fatigue, pain, anxiety, depression
Measured: Daily for 28 days
Missed School/Work/Activity
Self-report of the number of days where the participant missed school, work, or activities
Measured: Baseline, week 4, and week 8
Activity Tracker-step Count
Number of steps taken per day based reported through activity tracker
Measured: Daily for 28 days
Sleep Patterns
Number of minutes of sleep per day as reported through activity tracker
Measured: Weekly for 4 weeks
Inability to Concentrate
Self-report on inability to concentrate
Measured: Daily for 28 days
Asthma Belief Survey
The instrument is a 15-item tool that uses a 5-point self-report scale to measure asthma self-efficacy in relation to daily asthma maintenance and an asthma crisis. A rating of 1 = little confidence whereas a rating of 5 = a high confidence level. Responses are averaged across items to indicate an overall score ranging between 1 (low confidence) to 5 (high confidence)
Measured: Baseline, week 4, and week 8
Short Assessment of Health Literacy-English
18-item instrument to assess the ability to read and understand common medical terms. The total score range is 0-18. A score between 0 and 14 suggests the examinee has low health literacy.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start12 Jan 2022
- Primary completion29 Apr 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Asthma in ChildrenStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Michelle Nichols, PhD, RN, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742646
- Sponsor's protocol ID
- 00109618
- Other IDs
- 5P20NR016575-04
- Acronym
- MATADORS
- Status last verified
- Jul 2025
- First submitted
- 11 Jan 2023
- Last updated
- 23 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study: An mHealth Intervention to Facilitate Symptom Self-management Among Youth
- ClinicalTrials.gov ID
- NCT05742646
- Acronym / sponsor ID
- MATADORS / 00109618
- Conditions
- Asthma in Children, Obesity, Obesity, Adolescent, Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), National Institutes of Health (NIH)
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 24 Feb 2023 (actual)
- Results
- Posted 23 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this 4 week pilot study is to test the use of a mobile application (also commonly referred to as an app) designed to help increase self-management strategies among youth that have asthma and obesity. The data obtained from this study will facilitate refinement of the app and interventional approaches for a future larger scale study to increase youth self-management of their clinical conditions, symptom management, and health maintenance as they transition to adulthood.
Detailed description
Investigate the feasibility of a 4-week evidence-based, nurse-guided, mHealth self-management intervention application for youth with asthma and obesity (ages 10-17).
Aims are to conduct feasibility testing of the app with a sample of youth randomized to the intervention or control and to obtain estimates of variability and describe preliminary outcomes of the application on fatigue, pain, self-efficacy, anxiety, sleep, depression, and quality of life measured at baseline, 4, and 8 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MATADORS app basic information | Active comparator | Behavioral: MATADORS ControlThe basic app includes real-time symptom monitoring through ecological momentary assessment (EMA) and medication adherence. Basic SMS text messages are sent to participants with reminders to complete EMA questions and enter medication taken. Participants also are provided with activity trackers to assess physical activity and sleep patterns. |
| MATADORS app to include basic information and expanded educational features | Experimental | Behavioral: MATADORSParticipants in the experimental arm have access to the basic app, along with educational and resource-specific information on asthma, obesity, medications, symptom management, and lifestyle modifications. Features include images, text, and video content. Participants in the experimental arm also are provided with activity trackers to assess physical activity and sleep patterns. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Youth-Caregiver Dyad Inclusion Criteria:
Key exclusion criteria (3 listed)
- Diagnosis of cognitive impairment
- Inability or unwillingness of youth participant to assent and/or primary caregiver/legal guardian/representative to give informed consent
- Inability or unwillingness to participate in the audio recording interview session or complete study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MATADORSYouth will have access to the MATADORS app to include basic information and expanded educational features. They will be asked to log into the app daily for one month and they will be asked to report within the app how they are feeling each day and their medications taken. | Behavioural | MATADORS app to include basic information and expanded educational features |
| MATADORS ControlYouth will have access to the MATADORS app basic information. They will be asked to log into the app daily for one month and they will be asked to report within the app their medications taken. | Behavioural | MATADORS app basic information |
Primary outcome
Number of Participants Completing 4-week Study Period
Time frame: 4-week study period
Participant retention and feasibility in completing the 4-week study
15 secondary outcomes
Loss to Follow-up
Time frame: 8 weeks
Study Withdrawals
Time frame: 8 weeks
End of Study Dyadic Interviews
Time frame: 8 weeks
Change in Fatigue
Time frame: 8 weeks
Change in Self-Efficacy
Time frame: 8 weeks
Change in Asthma Control
Time frame: 8 weeks
Physical Activity Patterns
Time frame: Weekly for 6 weeks (weeks 1-6)
Medication Adherence
Time frame: Daily for 28 days
Symptom Reporting
Time frame: Daily for 28 days
Missed School/Work/Activity
Time frame: Baseline, week 4, and week 8
Activity Tracker-step Count
Time frame: Daily for 28 days
Sleep Patterns
Time frame: Weekly for 4 weeks
Inability to Concentrate
Time frame: Daily for 28 days
Asthma Belief Survey
Time frame: Baseline, week 4, and week 8
Short Assessment of Health Literacy-English
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Nichols, PhD, RN principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MATADORS in people with Asthma in Children and Obesity, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Completing 4-week Study Period (time frame: 4-week study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.