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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06432790
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
4 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • 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).

Study Details

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.

Key Dates

Start date
Jul 17, 2024
Status verified
Nov 2025
Primary completion
Jul 1, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Active Comparator: 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

Primary Outcome Measure

Change in Child Body Mass Index (BMI) [ Time Frame: 0-12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Sheila Kelly, MPH
[email protected]
617-726-8208
Lauren Fiechtner, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Massachusetts General Hospital· Boston, MA

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