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NCT06432790 | RECRUITING | Overweight, Childhood

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

Massachusetts General Hospital

Information provided by (Responsible Party):

Lauren G. Fiechtner, M.D.

Brief 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.

Condition or disease

Overweight, Childhood

Obesity, Childhood

Asthma in Children

Intervention/treatment

CHAMPION

Phase

NA

Detailed 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

Study Type : INTERVENTIONAL
Estimated Enrollment : 500 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person Vs. ONline (CHAMPION)
Actual Study Start Date : 2024-07-17
Estimated Primary Completion Date : 2028-07-01
Estimated Study Completion Date : 2028-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 6 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person Vs. ONline

Location Details

NCT06432790

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114