NCT00537160

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2006

Longer than P75 for early_phase_1 obesity

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2007

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 29, 2012

Status Verified

October 1, 2012

Enrollment Period

6.5 years

First QC Date

September 27, 2007

Last Update Submit

October 25, 2012

Conditions

ObesityBurns

Keywords

Pediatrics

Outcome Measures

Primary Outcomes (1)

  • BMI

    12 and 24 months following intervention

Secondary Outcomes (1)

  • fitness level

    12 and 24 months following intervention

Interventions

Behavior modification, Nutrition Education, ExerciseBEHAVIORAL

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityBurns

Interventions

Behavior TherapyNutrition AssessmentExercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Michele M Gottschlich, PhD, RD, CNSD

    Shriners Hospital for Children

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Dietitian

Study Record Dates

First Submitted

September 27, 2007

First Posted

September 28, 2007

Study Start

April 1, 2006

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

October 29, 2012

Record last verified: 2012-10