Managing AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Obesity, Adolescent; Obesity, Childhood; Asthma in Children; Obesity

Treatments: Behavioral: MATADORS; Behavioral: MATADORS Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05742646

00109618

5P20NR016575-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 10+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

MATADORS app basic information

Active Comparator group

Description:

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.

Treatment:

Behavioral: MATADORS Control

MATADORS app to include basic information and expanded educational features

Experimental group

Description:

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.

Treatment:

Behavioral: MATADORS