Actively Recruiting
Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline (CHAMPION)
Led by Massachusetts General Hospital · Updated on 2025-11-18
500
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the CHAMPION program, a healthy lifestyle and asthma management intervention for children with overweight or obesity and persistent asthma. This study compares the effectiveness of CHAMPION delivered via telehealth versus in-person in a randomized trial involving 500 children. The program integrates obesity and asthma care following national guidelines to improve access to effective treatments in primary care, especially for lower income and diverse populations. The study has two groups: one receiving CHAMPION via telehealth and the other receiving it in-person. For the first 6 months, participants have monthly individual and group visits (virtual or in-person depending on group), followed by a maintenance period from 6 to 12 months with monthly individual visits and two health coaching calls each month. The CHAMPION program includes a total of 30 hours of contact with a team consisting of a physician, dietician, and community health worker, with education and coaching to support healthy behaviors and asthma management. Participants will be involved over a 12-month period, attending regular clinic visits and coaching sessions. Researchers will assess changes in child body mass index (BMI), BMI z-score, asthma control, and quality of life related to asthma and obesity. Additional measures include diet quality, sleep, physical activity, screen time, asthma healthcare use, caregiver stress, family-centered care, telehealth satisfaction, attendance barriers, and eating symptoms. The study monitors results over the full year to understand how each delivery method influences health outcomes and program engagement.
CONDITIONS
Brief Title
Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child is between 4 and 17.9 years old at time of screening
- Child has a body mass index (BMI) at or above the 85th percentile
- Child has a diagnosis of asthma or reactive airway disease as documented in medical records and caregiver report
- Caregiver is 18 years or older and speaks English or Spanish
- Caregiver is the primary caregiver of the child
You will not qualify if you...
- Child has a diagnosis of anorexia nervosa
- Child is pregnant
- Caregiver plans to change the child's pediatrician within the next year
- Child has opted out of research participation
- Child has a sibling currently enrolled in this trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Duration - Up to 12 months
Participants receive the CHAMPION program, an intensive health behavior and lifestyle treatment integrating asthma and obesity management. The program involves monthly individual visits and group sessions (virtual or in-person depending on assignment), as well as health coaching calls during the maintenance phase.
Monthly individual visits and group sessions for the first 6 months, then monthly individual visits and 2 health coaching calls per month for months 6 to 12
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
L
Lauren Fiechtner, MD
S
Sheila Kelly, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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