Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline

Asthma in Children Clinical Trial

— CHAMPION  

Official title:

Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline (CHAMPION)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06432790
• Other study ID #: 2024P001418
• Secondary ID: TE-2022C3-30362
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2024
• Est. completion date: July 31, 2028

Study information

• Verified date: June 2024
• Source: Massachusetts General Hospital
• Contact: Lauren Fiechtner, MD
• Phone: 617-726-8705
• Email: lfiechtner[@]mgb.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: July 31, 2028
• Est. primary completion date: July 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children
• Obesity, Childhood
• Overweight
• Overweight, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• CHAMPION
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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Patient-Centered Outcomes Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Child Body Mass Index (BMI)	Measured as BMI based on child height and weight	0-12 months
Primary	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	0-12 months
Primary	Change in Asthma Control Test	Per Asthma Control Test	0-12 months
Primary	Change in Asthma and Obesity Specific Quality of Life	Per response to caregiver-proxy survey	0-12 months
Secondary	Change in Child Diet Quality	Diet quality per Primescreen, via caregiver-proxy survey	0-12 months
Secondary	Change in Child Average Hours of Sleep	Hours of sleep, via caregiver-proxy survey	0-12 months
Secondary	Change in Child Average Days of Physical Activity	Days physically active for at least 60 minutes per day, via caregiver-proxy survey	0-12 months
Secondary	Change in Child Average Hours of Screen Time	Hours of sedentary screen time, via caregiver-proxy survey	0-12 months
Secondary	Asthma-related healthcare utilization	Per response to caregiver-proxy survey	0-12 months
Secondary	Change in perceived stress (caregiver)	Per response to caregiver-proxy survey	0-12 months
Secondary	Family-centered care assessment	Per response to caregiver-proxy survey	12 months
Secondary	Telehealth satisfaction	Per response to caregiver-proxy survey	12 months
Secondary	Barriers to program attendance	Per response to caregiver-proxy survey	12 months
Secondary	Change in disordered eating symptoms	Per response to caregiver-proxy survey	0-12 months