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NCT03075306 · ClinicalTrials.gov registry record · NA
Randomized Trial of a Healthy Weight Intervention for Youth With Serious Emotional Disturbance
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 112
- Enrollment target
NCT03075306: Completed NA study, sponsored by Johns Hopkins University.
NCT03075306 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 112 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03075306, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 112 participants
- Enrollment target
Study Summary
The prevalence of overweight and obesity in youth with serious emotional disturbance (SED) exceeds the epidemic levels of overweight and obesity for children in the general population. Associated cardiovascular (CVD) risk factors such as glucose intolerance, hypertension and lipid abnormalities frequently already exist in obese children. Thus, focusing on overweight/obesity in youth with SED is critical to prevent their premature CVD. In 2015 the American Heart Association called attention to mental illnesses in youth as important risk conditions for early CVD and declared the need for transformational change in screening and management of overweight and obesity. Despite this, studies of healthy weight interventions in youth with SED are noticeably absent, and interventions will likely need to be tailored for this population who frequently have impulsivity, oppositional behavior and/or mood symptoms. In the general population, successful interventions targeting youth obesity often include active parental participation. Community mental health programs serving youth typically engage parents as part of routine treatment and therefore provide an unappreciated but potentially important opportunity to address overweight and obesity. The objective of this study is to design and rigorously test an innovative, scalable healthy weight intervention in youth with SED that incorporates parental engagement and provider support. The CHAMPION Trial is a two-arm trial partnering with community mental health organizations in Maryland. We will perform population-based screening to identify youth with overweight and obesity, and recruit and enroll 120 ages 8-18 years with SED with a BMI at or above the 85th%tile. The study will stratify by sex and site and randomly assign participants to receive a) usual care plus educational materials on healthy weight, or b) the 12-month CHAMPION intervention with a health coach who provides healthy lifestyle counseling and support for weight manage
Interventions
- BEHAVIORAL intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2018-02-02 |
| Est. Completion | 2021-02-19 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03075306
The ClinicalTrials.gov registry entry for NCT03075306 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which intervention is the first listed.
NCT03075306 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03075306 about?
NCT03075306 is a clinical study titled "Randomized Trial of a Healthy Weight Intervention for Youth With Serious Emotional Disturbance". The prevalence of overweight and obesity in youth with serious emotional disturbance (SED) exceeds the epidemic levels of overweight and obesity for children in the general population. Associated cardiovascular (CVD) risk factors such as glucose intolerance, hypertension and lipid abnormalities freq...
What is the current status of trial NCT03075306?
This trial is currently completed. It is a NA study. The enrollment target is 112 participants. The study started on 2018-02-02. Estimated completion is 2021-02-19.
What interventions are being tested in trial NCT03075306?
The interventions under investigation include: intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03075306?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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