Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person Vs. ONline
- Conditions
- Obesity, ChildhoodAsthma in ChildrenOverweight, Childhood
- Interventions
- Behavioral: CHAMPION
- Registration Number
- NCT06432790
- Lead Sponsor
- Massachusetts General Hospital
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CHAMPION via Telehealth 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 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
- Primary Outcome Measures
Name Time Method Change in Asthma and Obesity Specific Quality of Life 0-12 months Per response to caregiver-proxy survey
Change in Child Body Mass Index (BMI) 0-12 months Measured as BMI based on child height and weight
Change in Asthma Control Test 0-12 months Per Asthma Control Test
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
- Secondary Outcome Measures
Name Time Method Change in Child Diet Quality 0-12 months Diet quality per Primescreen, via caregiver-proxy survey
Change in disordered eating symptoms 0-12 months Per response to caregiver-proxy survey
Change in Child Average Hours of Sleep 0-12 months Hours of sleep, via caregiver-proxy survey
Family-centered care assessment 12 months Per response to caregiver-proxy survey
Telehealth satisfaction 12 months Per response to 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
Change in perceived stress (caregiver) 0-12 months Per response to caregiver-proxy survey
Asthma-related healthcare utilization 0-12 months Per response to caregiver-proxy survey
Barriers to program attendance 12 months Per response to caregiver-proxy survey
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States