Actively Recruiting

Phase Not Applicable
Age: 4Years - 17Years
All Genders
ID06432790

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

Age: 4Years - 17Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual)

Treatment

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

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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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