Managing AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study

NCT05742646 | Completed Results DMC

• 2 other identifiers: 001096185P20NR016575-04
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Completing 4-week Study Period

  Participant retention and feasibility in completing the 4-week study

  4-week study period

Secondary Outcomes (15)

• Loss to Follow-up

  8 weeks

• Study Withdrawals

  8 weeks

• End of Study Dyadic Interviews

  8 weeks

• Change in Fatigue

  8 weeks

• Change in Self-Efficacy

  8 weeks

Study Arms (2)

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.

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.

Behavioral: MATADORS

Interventions

MATADORS BEHAVIORAL

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 app to include basic information and expanded educational features

MATADORS Control BEHAVIORAL

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.

MATADORS app basic information

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of Nursing Research (NINR): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Obesity; Pediatric Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Michelle Nichols
• Organization: Medical University of South Carolina

nicholmg@musc.edu

8437928515

Study Officials

• Michelle Nichols, PhD, RN

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 24, 2023
• Study Start: January 12, 2022
• Primary Completion: April 29, 2022
• Study Completion: April 29, 2022
• Last Updated: July 23, 2025
• Results First Posted: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)