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Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person Vs. ONline

Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person Vs. ONline

Recruiting
6-17 years
All
Phase N/A

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Overview

The goal of this study is to evaluate the effectiveness of CHAMPION ("Comparative-effectiveness of a Healthy lifestyle and Asthma Management Program, In-person vs ONline"), a primary care-based intervention to address childhood obesity and asthma, and test the effectiveness of a telehealth-only version of the program. Intensive Health Behavior and Lifestyle Treatment (IHBLT), when delivered via telehealth vs. in-person among children with overweight or obesity and persistent asthma.

Description

This study will evaluate the comparative effectiveness of 1) telehealth delivery of CHAMPION vs. 2) in-person (standard of care) delivery of CHAMPION in a two-arm, individually randomized non-inferiority trial among 500 children. Obesity and asthma are two leading chronic diseases in children, and CHAMPION is an integration of the Healthy Weight Clinic (HWC) and pediatric Asthma Population Health Management Programming at Mass General Brigham. This study will address how to improve access to effective treatments consistent with United States Preventive Services Task Force (USPSTF) and American Academy of Pediatrics (AAP) guidelines that manage asthma and obesity concurrently in primary care among lower income diverse populations

Eligibility

Caregiver-proxies will be 18 years old or older, English or Spanish speaking, and a primary caregiver of a child meeting the following criteria:

Inclusion criteria

  • Age 6-17.9 years at time of screening
  • BMI ≥ 85th percentile
  • Asthma diagnosis, per child's Electronic Health Record (EHR) documentation or caregiver report

Exclusion criteria

  • Diagnosis of anorexia nervosa, per child's EHR or caregiver report
  • Pregnant, per child's EHR
  • Plan to change pediatricians in the next year, per caregiver report
  • Opted out of research, per child's EHR
  • Sibling currently enrolled in the research trial, per enrollment log or caregiver report

Study details
    Overweight
    Childhood
    Obesity
    Childhood
    Asthma in Children

NCT06432790

Massachusetts General Hospital

16 October 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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