Overweight, ChildhoodCHAMPIONNCT06432790
Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline
A study testing CHAMPION in people with Overweight, Childhood and Obesity, Childhood, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Overweight, Childhood, Obesity, Childhood, Asthma in Children
- What is being tested?
- CHAMPION
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2024to 31 Jul 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sheila Kelly, MPH contact
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Sheila Kelly, MPH, 617-726-8208, skelly45@mgh.harvard.edu
Lauren Fiechtner, MD, MPH
About this study
Official title: 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.
Read the 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
- Being tested
- CHAMPION
- Keywords
- telehealth
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHAMPIONBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: CHAMPION |
| 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 Receives: Behavioral: CHAMPION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Child Body Mass Index (BMI)
Measured as BMI based on child height and weight
Measured: 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
Measured: 0-12 months
Change in Asthma Control Test
Per Asthma Control Test
Measured: 0-12 months
Change in Asthma and Obesity Specific Quality of Life
Per response to caregiver-proxy survey
Measured: 0-12 months
Secondary outcomes (10)
Change in Child Diet Quality
Diet quality per Primescreen, via caregiver-proxy survey
Measured: 0-12 months
Change in Child Average Hours of Sleep
Hours of sleep, via caregiver-proxy survey
Measured: 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
Measured: 0-12 months
Change in Child Average Hours of Screen Time
Hours of sedentary screen time, via caregiver-proxy survey
Measured: 0-12 months
Asthma-related healthcare utilization
Per response to caregiver-proxy survey
Measured: 0-12 months
Change in perceived stress (caregiver)
Per response to caregiver-proxy survey
Measured: 0-12 months
Family-centered care assessment
Per response to caregiver-proxy survey
Measured: 12 months
Telehealth satisfaction
Per response to caregiver-proxy survey
Measured: 12 months
Barriers to program attendance
Per response to caregiver-proxy survey
Measured: 12 months
Change in disordered eating symptoms
Per response to caregiver-proxy survey
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start17 Jul 2024
- Primary completion1 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight, ChildhoodStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Lauren G. Fiechtner, M.D., Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432790
- Sponsor's protocol ID
- 2024P001418
- Other IDs
- TE-2022C3-30362
- Acronym
- CHAMPION
- Status last verified
- Nov 2025
- First submitted
- 22 May 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).