Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Location status: Recruiting
Location contact
Lauren Fiechtner, MD, MPH
PRINCIPAL_INVESTIGATOR
Sheila Kelly, MPH
CONTACT
NCT Number: NCT06432790
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.
Interested in participating?
Request Info4 year–17 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
Location status: Recruiting
Lauren Fiechtner, MD, MPH
PRINCIPAL_INVESTIGATOR
Sheila Kelly, MPH
CONTACT
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Exclusion criteria
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).
Time frame: 0-12 months
Measured as BMI based on child height and weight
Time frame: 0-12 months
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
Per Asthma Control Test
Time frame: 0-12 months
Per response to caregiver-proxy survey
Time frame: 0-12 months
Diet quality per Primescreen, via caregiver-proxy survey
Time frame: 0-12 months
Hours of sleep, via caregiver-proxy survey
Time frame: 0-12 months
Days physically active for at least 60 minutes per day, via caregiver-proxy survey
Time frame: 0-12 months
Hours of sedentary screen time, via caregiver-proxy survey
Time frame: 0-12 months
Per response to caregiver-proxy survey
Time frame: 0-12 months
Per response to caregiver-proxy survey
Time frame: 12 months
Per response to caregiver-proxy survey
Time frame: 12 months
Per response to caregiver-proxy survey
Time frame: 12 months
Per response to caregiver-proxy survey
Time frame: 0-12 months
Per response to caregiver-proxy survey
Contact information is provided by the study sponsor or research team.
Lauren Fiechtner, MD
CONTACT
Sheila Kelly, MPH
CONTACT
Massachusetts General Hospital
Other
Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline (CHAMPION)
Acronym: CHAMPION
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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