Randomized Trial of a Healthy Weight Intervention for Youth With Serious Emotional Disturbance
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss; Affective Symptoms
Study type: Interventional

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.
    


Intervention name(s): intervention
Intervention type(s): Behavioral
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment