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
- Are there results?
- Not yet: the study is under way
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).
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline (CHAMPION)
- ClinicalTrials.gov ID
- NCT06432790
- Acronym / sponsor ID
- CHAMPION / 2024P001418
- Keywords
- telehealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHAMPION via Telehealth | Experimental | Behavioral: CHAMPION* 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 | Behavioral: CHAMPION* 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 |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHAMPIONThe 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). | Behavioural | CHAMPION via In-Person, CHAMPION via Telehealth |
Primary outcome
Change in Child Body Mass Index (BMI)
Time frame: 0-12 months
Measured as BMI based on child height and weight
Change in Child BMI z-score
Time frame: 0-12 months
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
Change in Asthma Control Test
Time frame: 0-12 months
Per Asthma Control Test
Change in Asthma and Obesity Specific Quality of Life
Time frame: 0-12 months
Per response to caregiver-proxy survey
10 secondary outcomes
Change in Child Diet Quality
Time frame: 0-12 months
Change in Child Average Hours of Sleep
Time frame: 0-12 months
Change in Child Average Days of Physical Activity
Time frame: 0-12 months
Change in Child Average Hours of Screen Time
Time frame: 0-12 months
Asthma-related healthcare utilization
Time frame: 0-12 months
Change in perceived stress (caregiver)
Time frame: 0-12 months
Family-centered care assessment
Time frame: 12 months
Telehealth satisfaction
Time frame: 12 months
Barriers to program attendance
Time frame: 12 months
Change in disordered eating symptoms
Time frame: 0-12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: 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).
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Recruiting
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RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Enrolling by invitation
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sheila Kelly, MPH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHAMPION in people with Overweight, Childhood and Obesity, Childhood, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Fiechtner, MD (617-726-8705, lfiechtner@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Child Body Mass Index (BMI) (time frame: 0-12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.