Asthma in Children, Obesity, Childhood, Overweight, Childhood
Conditions
Keywords
telehealth
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.
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
BEHAVIORALCHAMPION
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).
Sponsors
Patient-Centered Outcomes Research Institute
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Child Body Mass Index (BMI) | 0-12 months | Measured as BMI based on child height and weight |
| Change in Child BMI z-score | 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 | 0-12 months | Per Asthma Control Test |
| Change in Asthma and Obesity Specific Quality of Life | 0-12 months | Per response to caregiver-proxy survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma-related healthcare utilization | 0-12 months | Per response to caregiver-proxy survey |
| Change in perceived stress (caregiver) | 0-12 months | Per response to caregiver-proxy survey |
| Family-centered care assessment | 12 months | Per response to caregiver-proxy survey |
| Change in Child Diet Quality | 0-12 months | Diet quality per Primescreen, via caregiver-proxy survey |
| Barriers to program attendance | 12 months | Per response to caregiver-proxy survey |
| Change in disordered eating symptoms | 0-12 months | Per response to caregiver-proxy survey |
| Telehealth satisfaction | 12 months | Per response to caregiver-proxy survey |
| Change in Child Average Hours of Sleep | 0-12 months | Hours of sleep, via caregiver-proxy survey |
| Change in Child Average Days of Physical Activity | 0-12 months | Days physically active for at least 60 minutes per day, via caregiver-proxy survey |
| Change in Child Average Hours of Screen Time | 0-12 months | Hours of sedentary screen time, via caregiver-proxy survey |
Countries
United States
Contacts
Primary ContactLauren Fiechtner, MD
Backup ContactSheila Kelly, MPH
Outcome results
None listed