Healthy Bodies, Healthy Kids
Condition: Child Mental Disorders; Obesity; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Mental Disorders; Neurodevelopmental Disorders
Study type: Interventional

Summary: 
      The US prevalence of childhood-onset obesity and type 2 diabetes, both predictors of
      cardiovascular risk, have increased to epidemic proportions in recent decades. Children with
      mental illness, especially those treated with antipsychotic medications, are at additional
      risk for obesity (adiposity) and related risk conditions. A variety of noninvasive techniques
      to assess cardiometabolic risk have begun to be applied in children, including body
      composition measured with dual energy x-ray absorptiometry (DEXA), carotid intima media
      thickness (CIMT) measured by ultrasound, and hepatic triglyceride content measured using
      magnetic resonance (MR) imaging-estimated proton density fat fraction (PDFF). These measures
      allow for the early, noninvasive study of adiposity-related metabolic risk. The overall aim
      of this two-study research plan is to characterize the level of measurable risk using these
      sensitive markers in treated and untreated children with mental health disorders, and to
      evaluate the magnitude of change in risk that can be observed using these biomarkers in
      children receiving a well established behavioral weight-loss intervention.
    

Detailed description: 
      This project will utilize sensitive, early biomarkers of disease risk, including whole body
      adiposity with DEXA, PDDF and CIMT, directly relevant to diabetes and cardiovascular disease
      risk. The primary goals of this study are to deliver an evidence-based weight loss
      intervention to the population of youth who are overweight or obese as a result of
      antipsychotic treatment, to characterize metabolic risk associated with weight using
      sensitive biomarkers, and to evaluate the magnitude of change observed in these biomarkers in
      children receiving an established behavioral weight-loss intervention.

      Aim 1: To evaluate the main effect of time of 16 weeks of a Behavioral Weight Loss (BWL)
      intervention on DEXA-measured whole body adiposity in overweight/obese antipsychotic
      (AP)-treated children compared to nonpsychiatric (NP) overweight or obese healthy controls,
      and in AP-treated youth randomized to monthly Usual Care (UC).

      Aim 2: To evaluate the main effect of time of 16 weeks of a BWL intervention on PDFF in
      overweight/obese AP-treated children compared to NP overweight or obese healthy controls, and
      in AP-treated youth randomized monthly UC.

      Aim 3: To evaluate the main effect of time of 16 weeks of a weekly behavioral weight loss
      intervention on CIMT in overweight/obese AP-treated children compared to NP overweight or
      obese healthy controls, and in AP-treated youth randomized monthly UC.
    

Intervention name(s): Behavioral Weight Loss; Diet and Exercise Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This intervention is a family-based, behavioral weight loss program that has been employed in studies with overweight and obese children, as well as with children who have diabetes. For the proposed study, the program has been modified to fit the needs of disruptive and behaviorally disturbed youth and their families. The modified program includes 16 weeks of weekly visits with a study interventionist, and supplemental phone contacts as needed. Phone contacts will only replace in-person visits if absolutely necessary to achieve the visit.; Participants assigned to this arm will receive monthly medically validated, individualized diet and exercise education by a trained research professional.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Child Psychiatry; Obesity; Antipsychotic