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| ID | Type | Description | Link |
|---|---|---|---|
| TE-2022C3-30362 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute (PCORI) |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHAMPION via Telehealth | Experimental |
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| CHAMPION via In-Person | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Child Body Mass Index (BMI) | Measured as BMI based on child height and weight | 0-12 months |
| 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 |
| Change in Asthma Control Test | Per Asthma Control Test | 0-12 months |
| Change in Asthma and Obesity Specific Quality of Life | Per response to caregiver-proxy survey | 0-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Child Diet Quality | Diet quality per Primescreen, via caregiver-proxy survey | 0-12 months |
| Change in Child Average Hours of Sleep | Hours of sleep, via caregiver-proxy survey |
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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
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren Fiechtner, MD | Contact | 617-726-8705 | lfiechtner@mgb.org | |
| Sheila Kelly, MPH | Contact | skelly45@mgh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
The funder, PCORI, requires data to be deposited into the Patient Centered Outcomes Data Repository/University of Michigan Inter-university Consortium for Political and Social Research (ICPSR).
Data will be deposited after study completion.
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| 0-12 months |
| 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 |
| Change in Child Average Hours of Screen Time | Hours of sedentary screen time, via caregiver-proxy survey | 0-12 months |
| Asthma-related healthcare utilization | Per response to caregiver-proxy survey | 0-12 months |
| Change in perceived stress (caregiver) | Per response to caregiver-proxy survey | 0-12 months |
| Family-centered care assessment | Per response to caregiver-proxy survey | 12 months |
| Telehealth satisfaction | Per response to caregiver-proxy survey | 12 months |
| Barriers to program attendance | Per response to caregiver-proxy survey | 12 months |
| Change in disordered eating symptoms | Per response to caregiver-proxy survey | 0-12 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |