Randomized Trial of a Healthy Weight Intervention for Youth With Serious Emotional Disturbance (CHAMPION)

December 8, 2025 updated by: Johns Hopkins University
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 management, a healthy diet and increased physical activity incorporating techniques to engage both the youth and parents. The intervention's first 6 months will include frequent contacts, followed by a 6-month maintenance phase. The primary outcome will be decreased BMI z-score compared to control at 12 months; secondary outcomes include waist circumference, blood pressure, glucose, lipid levels, quality of life, and psychiatric symptoms at 6 and 12 mo. Antecedents of CVD begin early in youth, and those with SED are at particularly high risk. Breaking this cascade of risk factors leading to premature CVD will require capitalizing on the window of opportunity to intervene on overweight and obesity in youth with SED. The CHAMPION Trial will test an innovative, yet practical approach that could be readily incorporated into overall care of youth with SED.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Children's Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ages 8 through 18 years

    • Measured BMI ≥ 85th percentile for age and sex
    • Currently receiving specialty mental health outpatient treatment
    • Consent by parent and assent by child
    • Completion of baseline data collection
    • Willing to accept randomization, and to participate in the intervention

Exclusion Criteria:

  • Does not speak or understand English
  • Developmental delay precluding integrity or completion of study procedures
  • Primary 1 °substance-related disorders unless co-occur with another DSM mental or emotional disorder
  • Serious health condition or medical disability likely to hinder accurate measurement of weight, for which weight loss is contraindicated (e.g. bulimia nervosa) or which would likely cause weight loss
  • Prader-Willi Syndrome or other similar genetic disorder of obesity
  • Weight greater than 400 pounds
  • Chronic or repetitive use of non-psychiatric medications likely to cause weight gain or prevent weight loss (e.g., corticosteroids)
  • Weight loss (>=5% of body weight) within last 6 months
  • Pregnant or nursing.
  • Planning to leave clinic within 6 mo. or move out of area within 12 mo.
  • Investigator discretion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: usual care
usual care and materials on healthy weight
Experimental: intervention
the 12-month CHAMPION intervention with a health coach who provides healthy lifestyle counseling and support for weight management, a healthy diet and increased physical activity incorporating techniques to engage both the youth and parents
Behavioral: intervention
the 12-month CHAMPION intervention with a health coach who provides healthy lifestyle counseling and support for weight management, a healthy diet and increased physical activity incorporating techniques to engage both the youth and parents

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
BMI Z score
Time Frame: 12 months
body mass index Z score
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gaul Daumit, MD, MHS, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 19, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 19, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00130511
  • MH110968 (Other Identifier: National Institute of Mental Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

via NIMH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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