Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline (CHAMPION)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- Change in Asthma and Obesity Specific Quality of Life
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 17 Years (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
CHAMPION via Telehealth
- 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
Intervention: CHAMPION (Behavioral)
CHAMPION via In-Person
- 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
Intervention: CHAMPION (Behavioral)
Outcomes
Primary Outcomes
Change in Asthma and Obesity Specific Quality of Life
Time Frame: 0-12 months
Per response to caregiver-proxy survey
Change in Child Body Mass Index (BMI)
Time Frame: 0-12 months
Measured as BMI based on child height and weight
Change in Asthma Control Test
Time Frame: 0-12 months
Per Asthma Control Test
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
Secondary Outcomes
- Asthma-related healthcare utilization(0-12 months)
- Change in Child Diet Quality(0-12 months)
- Change in disordered eating symptoms(0-12 months)
- Change in Child Average Hours of Sleep(0-12 months)
- Family-centered care assessment(12 months)
- Telehealth satisfaction(12 months)
- Change in Child Average Days of Physical Activity(0-12 months)
- Change in Child Average Hours of Screen Time(0-12 months)
- Change in perceived stress (caregiver)(0-12 months)
- Barriers to program attendance(12 months)
Investigators
Lauren G. Fiechtner, M.D.
Assistant Professor of Pediatrics
Massachusetts General Hospital