Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CHAMPION.
- Who it may be relevant to
- Registry conditions: Overweight, Childhood, Obesity, Childhood, Asthma in Children. Basic parameters: 4 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline (CHAMPION)
Overview
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
Interventions
- 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 wi
Primary outcome measures
- 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]
Secondary outcome measures (10)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT06432790 · 2024P001418 · TE-2022C3-30362