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WithdrawnNCT00537160Updated Oct 29, 2012

Diet and Exercise in Overweight Children Postburn

An Early Phase 1 interventional study of Behavior modification, Nutrition Education, Exercise in Obesity and Burns, sponsored by Shriners Hospitals for Children. Withdrawn. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2012-10-29.

Sponsored by Shriners Hospitals for Children · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
10 Years to 18 Years
Sex
All
01

Study summary

Examine clinical results of an interdisciplinary weight management program that includes medical evaluation, nutrition counseling, exercise, and behavioral interventions.

02

Conditions studied

  • Obesity
  • Burns

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Keywords

  • Pediatrics
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 850 are open to participants now.

Browse Overweight studies →

Lead sponsor

Shriners Hospitals for Children is the lead sponsor of 56 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All

Inclusion criteria

  • 10-18 years old
  • BMI > or = 95th percentile
  • > 1 year postburn and out of pressure garments
  • Live within 100 minle radius of SHC
  • Informed consent and HIPPA form signed
  • Parent/guardia willing to make time commitment

Exclusion criteria

Exclusion Criteria:

  • Undergone major surgery in the 4 months prior to start of program or have any major surgery planned in 2 year time frame
  • Physical/health condition that precludes regular exercise
  • Significant mental health diagnosis
  • Advised by MD not to exercise
  • Thyroid disease, routine steroid use,pregnancy
  • Unable to understand the instructions/content of program
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Interventions

  • BehavioralBehavior modification, Nutrition Education, Exercise
06

What researchers measure

Primary outcomes

  1. BMI

    Time frame: 12 and 24 months following intervention

Secondary outcomes

  1. fitness level

    Time frame: 12 and 24 months following intervention

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00537160
Lead sponsor
Shriners Hospitals for Children
Responsible party
Michele Gottschlich (Research Dietitian, Shriners Hospitals for Children) — Principal investigator
First posted
Sep 28, 2007
Start date
Apr 2006
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Oct 29, 2012

Study contacts

Michele M Gottschlich, PhD, RD, CNSD
principal investigator · Shriners Hospital for Children

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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