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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
500
The CHAMPION program is an intensive health behavior and lifestyle treatment (IHBLT), formed through the integration of the Healthy Weight Clinic IHBLT and with MGB's pediatric Asthma Population Health Management Program. It consists of 30 hours of contact time with the CHAMPION team (physician, dietician, community health worker), consistent with the USPSTF and AAP recommendations, monthly individual clinic visits with the team (in person or virtual, per randomization), health coaching calls with a community health worker and/or registered dietician, monthly group sessions (in the first six months), and educational materials for families that reinforce healthy lifestyle behaviors and provide self-management education. In this study, all participants will participate in CHAMPION, but one arm will receive the experimental form (delivery via telehealth) and the other arm will receive the active comparator (delivery via telehealth).
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGChange in Child Body Mass Index (BMI)
Measured as BMI based on child height and weight
Time frame: 0-12 months
Change in Child BMI z-score
Measured as BMI based on child height and weight, and derived from Centers for Disease Control and Prevention (CDC) growth curves accounting for child age and sex
Time frame: 0-12 months
Change in Asthma Control Test
Per Asthma Control Test
Time frame: 0-12 months
Change in Asthma and Obesity Specific Quality of Life
Per response to caregiver-proxy survey
Time frame: 0-12 months
Change in Child Diet Quality
Diet quality per Primescreen, via caregiver-proxy survey
Time frame: 0-12 months
Change in Child Average Hours of Sleep
Hours of sleep, via caregiver-proxy survey
Time frame: 0-12 months
Change in Child Average Days of Physical Activity
Days physically active for at least 60 minutes per day, via caregiver-proxy survey
Time frame: 0-12 months
Change in Child Average Hours of Screen Time
Hours of sedentary screen time, via caregiver-proxy survey
Time frame: 0-12 months
Asthma-related healthcare utilization
Per response to caregiver-proxy survey
Time frame: 0-12 months
Change in perceived stress (caregiver)
Per response to caregiver-proxy survey
Time frame: 0-12 months
Family-centered care assessment
Per response to caregiver-proxy survey
Time frame: 12 months
Telehealth satisfaction
Per response to caregiver-proxy survey
Time frame: 12 months
Barriers to program attendance
Per response to caregiver-proxy survey
Time frame: 12 months
Change in disordered eating symptoms
Per response to caregiver-proxy survey
Time frame: 0-12 months
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