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

Mass General Brigham

Status: Enrolling

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

Treatments: Behavioral: CHAMPION

Study type: Interventional

Funder types: Other

Identifiers

NCT06432790

TE-2022C3-30362 (Other Grant/Funding Number)

2024P001418

Details and patient eligibility

About

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.

Full 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

Enrollment: 500 estimated patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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500 participants in 2 patient groups

CHAMPION via Telehealth

Experimental group

Description:

* Intensive 0-6 months: 1 individual visit monthly (virtual), 1 group visit monthly (virtual) * Maintenance 6-12 months: 1 individual visit monthly (virtual), 2 health coaching calls per month

Treatment:

Behavioral: CHAMPION

CHAMPION via In-Person

Active Comparator group

Description:

* Intensive 0-6 months: 1 individual visit monthly (in-person), 1 group visit monthly (in-person) * Maintenance 6-12 months: 1 individual visit monthly (in-person), 2 health coaching calls per month

Treatment:

Behavioral: CHAMPION