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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-17

Study Completion Date

2028-07-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Overweight, Childhood Obesity, Childhood Asthma in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

CHAMPION

Intervention Type BEHAVIORAL

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).

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

Group Type ACTIVE_COMPARATOR

CHAMPION

Intervention Type BEHAVIORAL

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).

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No