Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06432790

Recruiting nowNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age4 Years to 17 Years

SexAll

Healthy volunteersNot accepted

ConditionOverweight, Childhood, Obesity, Childhood, Asthma in Children

Full registry 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

Treatments and study arms

CHAMPION

Behavioral

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).

Primary outcomes

Change in Child Body Mass Index (BMI)0-12 months

Measured as BMI based on child height and weight

Change in Child BMI z-score0-12 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

Change in Asthma Control Test0-12 months

Per Asthma Control Test

Change in Asthma and Obesity Specific Quality of Life0-12 months

Per response to caregiver-proxy survey

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Massachusetts General Hospital🇺🇸 Boston, Massachusetts, United States

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Sheila Kelly, MPHContact

Email · Call 617-726-8208

Lauren Fiechtner, MD, MPHPrincipal Investigator