Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-17
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
CHAMPION
BehavioralThe 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).
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: CHAMPION via TelehealthExperimental treatment 1 intervention
Group B: CHAMPION via In-PersonActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Child Body Mass Index (BMI)
Measured as BMI based on child height and weight
Time frame
0-12 months2
Change in Child BMI z-score
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
Time frame
0-12 months3
Change in Asthma Control Test
Per Asthma Control Test
Time frame
0-12 months4
Change in Asthma and Obesity Specific Quality of Life
Per response to caregiver-proxy survey
Time frame
0-12 monthsSecondary outcomes
1
Change in Child Diet Quality
Diet quality per Primescreen, via caregiver-proxy survey
Time frame
0-12 months2
Change in Child Average Hours of Sleep
Hours of sleep, via caregiver-proxy survey
Time frame
0-12 months3
Change in Child Average Days of Physical Activity
Days physically active for at least 60 minutes per day, via caregiver-proxy survey
Time frame
0-12 months4
Change in Child Average Hours of Screen Time
Hours of sedentary screen time, via caregiver-proxy survey
Time frame
0-12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov