Recruiting

Healthy Lifestyle & Asthma Management

Sponsor:

Massachusetts General Hospital

Code:

NCT06432790

Conditions

Overweight, Childhood

Obesity, Childhood

Asthma in Children

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

Interventions

CHAMPION

Study Details

Brief 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.

Conditions

Overweight, Childhood

Obesity, Childhood

Asthma in Children

Study ID

NCT06432790

Start date

Jul 17, 2024

Status verified date

Nov, 2025

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CHAMPION via Telehealth

  • Intensive 0-6 months: 1 individual visit monthly (virtual), 1 group visit monthly (virtual)
  • Maintenance 6-12 months: 1 individual visit monthly (virtual), 2 health coaching calls per month

active comparator: CHAMPION via In-Person

  • Intensive 0-6 months: 1 individual visit monthly (in-person), 1 group visit monthly (in-person)
  • Maintenance 6-12 months: 1 individual visit monthly (in-person), 2 health coaching calls per month

Interventions

CHAMPION

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 outcome measure

  • Change in Child Body Mass Index (BMI) [ Time Frame: 0-12 months ]
  • Change in Child BMI z-score [ Time Frame: 0-12 months ]
  • Change in Asthma Control Test [ Time Frame: 0-12 months ]
  • Change in Asthma and Obesity Specific Quality of Life [ Time Frame: 0-12 months ]

Central Contacts and Locations

Central contacts

Lauren Fiechtner, MD

617-726-8705lfiechtner@mgb.org

Sheila Kelly, MPH

skelly45@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Sheila Kelly, MPH

617-726-8208skelly45@mgh.harvard.edu

Principal Investigator:

Lauren Fiechtner, MD, MPH

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 18, 2025

Last verified

Nov, 2025

Keywords

  • telehealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-11-18.