Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline
CHAMPION
2 other identifiers
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2024
CompletedFirst Posted
Study publicly available on registry
May 29, 2024
CompletedStudy Start
First participant enrolled
July 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2028
November 18, 2025
November 1, 2025
4 years
May 22, 2024
November 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
Secondary Outcomes (10)
Change in Child Diet Quality
0-12 months
Change in Child Average Hours of Sleep
0-12 months
Change in Child Average Days of Physical Activity
0-12 months
Change in Child Average Hours of Screen Time
0-12 months
Asthma-related healthcare utilization
0-12 months
- +5 more secondary outcomes
Study Arms (2)
CHAMPION via Telehealth
EXPERIMENTAL* 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
CHAMPION via In-Person
ACTIVE COMPARATOR* 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
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics
Study Record Dates
First Submitted
May 22, 2024
First Posted
May 29, 2024
Study Start
July 17, 2024
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 31, 2028
Last Updated
November 18, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- Data will be deposited after study completion.
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).