Clinical trial NCT06432790: Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person Vs. ONline
Official title: Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person Vs. ONline (CHAMPION)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight, Childhood
Obesity, Childhood
Asthma in Children
Keywords: telehealth
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2024-05-29
Enrollment: 500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 6-17.9 years at time of screening
* BMI ≥ 85th percentile
* Asthma diagnosis, per child's Electronic Health Record (EHR) documentation or 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

Primary outcomes:
measure: Change in Child Body Mass Index (BMI)
timeFrame: 0-12 months
measure: Change in Child BMI z-score
timeFrame: 0-12 months
measure: Change in Asthma Control Test
timeFrame: 0-12 months
measure: Change in Asthma and Obesity Specific Quality of Life
timeFrame: 0-12 months
Secondary outcomes:
measure: Change in Child Diet Quality
timeFrame: 0-12 months
measure: Change in Child Average Hours of Sleep
timeFrame: 0-12 months
measure: Change in Child Average Days of Physical Activity
timeFrame: 0-12 months
measure: Change in Child Average Hours of Screen Time
timeFrame: 0-12 months
measure: Asthma-related healthcare utilization
timeFrame: 0-12 months
measure: Change in perceived stress (caregiver)
timeFrame: 0-12 months
measure: Family-centered care assessment
timeFrame: 12 months
measure: Telehealth satisfaction
timeFrame: 12 months
measure: Barriers to program attendance
timeFrame: 12 months
measure: Change in disordered eating symptoms
timeFrame: 0-12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: