RecruitingNot ApplicableNCT06432790

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 (CHAMPION)


Sponsor

Massachusetts General Hospital

Enrollment

500 participants

Start Date

Jul 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 4 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two versions of a healthy lifestyle and asthma management program for overweight or obese children with asthma — one delivered in person and one delivered online — to see which is more effective. **You may be eligible if...** - Your child is between 4 and 17 years old - Your child has a BMI at or above the 85th percentile for their age (overweight or obese) - Your child has been diagnosed with asthma or reactive airway disease, documented in their medical record - You are the primary caregiver and are 18 or older, and can communicate in English or Spanish **You may NOT be eligible if...** - Your child has been diagnosed with anorexia nervosa - Your child is pregnant - You plan to switch pediatricians within the next year - Your child has previously opted out of research participation - A sibling of your child is already enrolled in this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCHAMPION

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).


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT06432790


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