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NCT Number: NCT06432790

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

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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Key information

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Lauren Fiechtner, MD, MPH

PRINCIPAL_INVESTIGATOR

Sheila Kelly, MPH

CONTACT

[email protected]

617-726-8208

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

CHAMPION

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).

Primary outcomes

  1. Change in Child Body Mass Index (BMI)

    Time frame: 0-12 months

    Measured as BMI based on child height and weight

  2. Change in Child BMI z-score

    Time frame: 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

  3. Change in Asthma Control Test

    Time frame: 0-12 months

    Per Asthma Control Test

  4. Change in Asthma and Obesity Specific Quality of Life

    Time frame: 0-12 months

    Per response to caregiver-proxy survey

Secondary outcomes

  1. Change in Child Diet Quality

    Time frame: 0-12 months

    Diet quality per Primescreen, via caregiver-proxy survey

  2. Change in Child Average Hours of Sleep

    Time frame: 0-12 months

    Hours of sleep, via caregiver-proxy survey

  3. Change in Child Average Days of Physical Activity

    Time frame: 0-12 months

    Days physically active for at least 60 minutes per day, via caregiver-proxy survey

  4. Change in Child Average Hours of Screen Time

    Time frame: 0-12 months

    Hours of sedentary screen time, via caregiver-proxy survey

  5. Asthma-related healthcare utilization

    Time frame: 0-12 months

    Per response to caregiver-proxy survey

  6. Change in perceived stress (caregiver)

    Time frame: 0-12 months

    Per response to caregiver-proxy survey

  7. Family-centered care assessment

    Time frame: 12 months

    Per response to caregiver-proxy survey

  8. Telehealth satisfaction

    Time frame: 12 months

    Per response to caregiver-proxy survey

  9. Barriers to program attendance

    Time frame: 12 months

    Per response to caregiver-proxy survey

  10. Change in disordered eating symptoms

    Time frame: 0-12 months

    Per response to caregiver-proxy survey

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren Fiechtner, MD

CONTACT

[email protected]

617-726-8705

Sheila Kelly, MPH

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Acronym: CHAMPION

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
May 29, 2024
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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