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 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 1) a health coach, a trained mental health program employee, 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;
and 2) support from health providers who will provide basic weight management messages and
encouragement for behavior change. 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.