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NCT01222494 · ClinicalTrials.gov registry record · NA

Healthy Bodies, Healthy Kids

A NA study, sponsored by Washington University School of Medicine.

Completed
Registry status
NA
Development phase
47
Enrollment target

NCT01222494: Completed NA study, sponsored by Washington University School of Medicine.

NCT01222494 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 47 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01222494, a NA study, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
NA
Development phase
47 participants
Enrollment target

Study 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.

Primary Outcome

Dual-Energy X-Ray Absorptiometry (DEXA) will be used to assess body fat at baseline and following 16 weeks of participation in a behavioral weight loss intervention.

Interventions

  • BEHAVIORAL Behavioral Weight Loss
  • BEHAVIORAL Diet and Exercise Education

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2011-07
Est. Completion 2017-03
Phase NA

What the finished NCT01222494 record still lists

NCT01222494 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Behavioral Weight Loss is the first listed.

NCT01222494 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01222494 about?

NCT01222494 is a clinical study titled "Healthy Bodies, Healthy Kids". 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) an...

What is the current status of trial NCT01222494?

This trial is currently completed. It is a NA study. The enrollment target is 47 participants. The study started on 2011-07. Estimated completion is 2017-03.

What interventions are being tested in trial NCT01222494?

The interventions under investigation include: Behavioral Weight Loss (BEHAVIORAL), Diet and Exercise Education (BEHAVIORAL).

Who is sponsoring clinical trial NCT01222494?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01222494's enrollment target sits among peer trials

47 1400th of 2000 higher than 599 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01222494, the US trial registry maintained by the National Library of Medicine. NCT01222494 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.