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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma in Children; Obesity, Childhood; Overweight, Childhood
• Intervention / Treatment: Behavioral: CHAMPION

Detailed Description

This study will evaluate the comparative effectiveness of 1) telehealth delivery of CHAMPION vs. 2) in-person (standard of care) delivery of CHAMPION in a two-arm, individually randomized non-inferiority trial among 500 children. Obesity and asthma are two leading chronic diseases in children, and CHAMPION is an integration of the Healthy Weight Clinic (HWC) and pediatric Asthma Population Health Management Programming at Mass General Brigham. This study will address how to improve access to effective treatments consistent with United States Preventive Services Task Force (USPSTF) and American Academy of Pediatrics (AAP) guidelines that manage asthma and obesity concurrently in primary care among lower income diverse populations

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Fiechtner, MD; Phone Number: 617-726-8705; Email: lfiechtner@mgb.org
• Study Contact Backup: Name: Sheila Kelly, MPH; Email: skelly45@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Sheila Kelly, MPH; Phone Number: 617-726-8208; Email: skelly45@mgh.harvard.edu
      • Principal Investigator: Lauren Fiechtner, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Behavioral: 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).
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	Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Asthma Control Test	Per Asthma Control Test	0-12 months
Change in Asthma and Obesity Specific Quality of Life	Per response to caregiver-proxy survey	0-12 months
Change in Child Body Mass Index (BMI)	Measured as BMI based on child height and weight	0-12 months
Change in Child BMI z-score	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	0-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Child Diet Quality	Diet quality per Primescreen, via caregiver-proxy survey	0-12 months
Change in Child Average Hours of Sleep	Hours of sleep, via caregiver-proxy survey	0-12 months
Change in Child Average Days of Physical Activity	Days physically active for at least 60 minutes per day, via caregiver-proxy survey	0-12 months
Change in Child Average Hours of Screen Time	Hours of sedentary screen time, via caregiver-proxy survey	0-12 months
Asthma-related healthcare utilization	Per response to caregiver-proxy survey	0-12 months
Change in perceived stress (caregiver)	Per response to caregiver-proxy survey	0-12 months
Family-centered care assessment	Per response to caregiver-proxy survey	12 months
Telehealth satisfaction	Per response to caregiver-proxy survey	12 months
Barriers to program attendance	Per response to caregiver-proxy survey	12 months
Change in disordered eating symptoms	Per response to caregiver-proxy survey	0-12 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Patient-Centered Outcomes Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: telehealth
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Pediatric Obesity
• Other Study ID Numbers: 2024P001418; TE-2022C3-30362 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The funder, PCORI, requires data to be deposited into the Patient Centered Outcomes Data Repository/University of Michigan Inter-university Consortium for Political and Social Research (ICPSR).
• IPD Sharing Time Frame: Data will be deposited after study completion.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No