Randomized Trial of a Healthy Weight Intervention for Youth With Serious Emotional Disturbance (CHAMPION)
Primary Purpose
Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
intervention
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins Children's Mental Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
usual care
intervention
Arm Description
usual care and materials on healthy weight
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
Outcomes
Primary Outcome Measures
BMI Z score
body mass index Z score
Secondary Outcome Measures
Full Information
NCT ID
NCT03075306
First Posted
March 4, 2017
Last Updated
August 12, 2021
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT03075306
Brief Title
Randomized Trial of a Healthy Weight Intervention for Youth With Serious Emotional Disturbance
Acronym
CHAMPION
Official Title
Randomized Trial of a Healthy Weight Intervention for Youth With Serious Emotional Disturbance
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 2, 2018 (Actual)
Primary Completion Date
February 19, 2021 (Actual)
Study Completion Date
February 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
usual care
Arm Type
No Intervention
Arm Description
usual care and materials on healthy weight
Arm Title
intervention
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
BMI Z score
Description
body mass index Z score
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaul Daumit, MD, MHS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Children's Mental Health Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
via NIMH
Learn more about this trial
Randomized Trial of a Healthy Weight Intervention for Youth With Serious Emotional Disturbance
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