Clinical trial NCT05742646: Managing AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study
Official title: Managing AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study: An mHealth Intervention to Facilitate Symptom Self-management Among Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Obesity
Obesity, Adolescent
Obesity, Childhood
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: National Institutes of Health (NIH)
First posted: 2023-02-24
Enrollment: 24
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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
  * 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of participants completing 4-week study period
timeFrame: 4-week study period
Secondary outcomes:
measure: Loss to follow-up
timeFrame: 8 weeks
measure: Study withdrawals
timeFrame: 8 weeks
measure: End of study dyadic interviews
timeFrame: 8 weeks
measure: Change in Fatigue
timeFrame: 8 weeks
measure: Change in Self-Efficacy
timeFrame: 8 weeks
measure: Change in Asthma Control
timeFrame: 8 weeks
measure: Physical Activity Patterns
timeFrame: Daily for 28 days
measure: Medication adherence
timeFrame: Daily for 28 days
measure: Symptom reporting
timeFrame: Daily for 28 days
measure: Missed school/work/activity
timeFrame: Baseline, week 4, and week 8
measure: Activity tracker-step count
timeFrame: Daily for 28 days
measure: Sleep patterns
timeFrame: Daily for 28 days
measure: Inability to concentrate
timeFrame: Daily for 28 days
measure: Daytime sleepiness
timeFrame: Daily for 28 days
measure: Asthma Belief Survey
timeFrame: Baseline, week 4, and week 8
measure: Short Assessment of Health Literacy-English
timeFrame: Baseline
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: