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

NCT06432790 · Massachusetts General Hospital

Recruiting

In plain English

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Official title

Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline (CHAMPION)

About this study

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 criteria

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 4-17.9 years at time of screening * BMI ≥ 85th percentile * Asthma or reactive airway disease diagnosis, per child's Electronic Health Record (EHR) documentation and 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 design

Enrollment target: 500 participants

Allocation: randomized

Masking: double

Age groups: child

Timeline

Starts: 2024-07-17

Estimated completion: 2028-07-31

Last updated: 2025-11-18

Interventions

Behavioral: CHAMPION

Primary outcomes

• Change in Child Body Mass Index (BMI) (0-12 months)
• Change in Child BMI z-score (0-12 months)
• Change in Asthma Control Test (0-12 months)

Sponsor

Massachusetts General Hospital · other

With: Patient-Centered Outcomes Research Institute

Contacts & investigators

ContactLauren Fiechtner, MD · contact · lfiechtner@mgb.org · 617-726-8705

ContactSheila Kelly, MPH · contact · skelly45@mgh.harvard.edu

All locations (1)

Massachusetts General HospitalRecruiting

Boston, Massachusetts, United States

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