Managing AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study (MATADORS)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Asthma in Children; Obesity, Childhood; Obesity, Adolescent
• Intervention / Treatment: Behavioral: MATADORS Control; Behavioral: MATADORS

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MATADORS app basic information; 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.	Behavioral: MATADORS Control; 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.
Experimental: MATADORS app to include basic information and expanded educational features; 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.	Behavioral: MATADORS; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Completing 4-week Study Period	Participant retention and feasibility in completing the 4-week study	4-week study period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks
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)	Baseline, week 4, and week 8
Loss to Follow-up	Number of participants lost to follow-up	8 weeks
Study Withdrawals	Number of participants who self withdrew from the study	8 weeks
End of Study Dyadic Interviews	Number of completed end of study dyadic interviews	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	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.	8 weeks
Physical Activity Patterns	Number of minutes active per day	Weekly for 6 weeks (weeks 1-6)
Medication Adherence	Self-report of rescue and/or controller medication usage	Daily for 28 days
Symptom Reporting	Number of days reporting symptoms of fatigue, pain, anxiety, depression	Daily for 28 days
Missed School/Work/Activity	Self-report of the number of days where the participant missed school, work, or activities	Baseline, week 4, and week 8
Activity Tracker-step Count	Number of steps taken per day based reported through activity tracker	Daily for 28 days
Sleep Patterns	Number of minutes of sleep per day as reported through activity tracker	Weekly for 4 weeks
Inability to Concentrate	Self-report on inability to concentrate	Daily for 28 days
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.	Baseline

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute of Nursing Research (NINR); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Michelle Nichols, PhD, RN, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Actual): April 29, 2022
• Study Completion (Actual): April 29, 2022

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Overweight; Obesity; Asthma; Pediatric Obesity
• Other Study ID Numbers: 00109618; 5P20NR016575-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No