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Parent-Based Treatment for Pediatric Overweight (PO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00807560
First Posted: December 12, 2008
Last Update Posted: January 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
Results First Submitted: March 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Overweight
Obesity
Interventions: Behavioral: FBT-PO
Behavioral: NEC

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
FBT-PO

Family Based Therapy for Pediatric Overweight.

FBT-PO : The goal of FBT-PO is to resolve the eating disorder and return the patient to healthy psychosocial and physiological developmental trajectories through active family involvement across three treatment phases.

NEC- Control

Nutritional Educational Control Condition (NEC).

NEC : Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks.


Participant Flow:   Overall Study
    FBT-PO   NEC- Control
STARTED   38   39 
COMPLETED   38   39 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
FBT-PO Family Based Therapy for Pediatric Overweight
NEC-control Nutritional Educational Control Condition
Total Total of all reporting groups

Baseline Measures
   FBT-PO   NEC-control   Total 
Overall Participants Analyzed 
[Units: Participants]
 38   39   77 
Age 
[Units: Years]
Mean (Standard Deviation)
 15.0  (1.52)   15.2  (1.6)   15.1  (1.56) 
Gender 
[Units: Participants]
     
Female   25   27   52 
Male   13   12   25 
Region of Enrollment 
[Units: Participants]
     
United States   38   39   77 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   BMI Z Score   [ Time Frame: baseline ]

2.  Primary:   BMI Z Score   [ Time Frame: up to 44 weeks ]

3.  Secondary:   Percent Completion   [ Time Frame: at 44 weeks ]

4.  Secondary:   Waist Measurement   [ Time Frame: baseline ]

5.  Secondary:   Waist Measurement   [ Time Frame: up to 44 weeks ]

6.  Secondary:   Hip Measurement   [ Time Frame: baseline ]

7.  Secondary:   Hip Measurement   [ Time Frame: up to 44 weeks ]

8.  Secondary:   Height   [ Time Frame: Baseline ]

9.  Secondary:   Height   [ Time Frame: up to 44 weeks ]

10.  Secondary:   Weight   [ Time Frame: baseline ]

11.  Secondary:   Weight   [ Time Frame: up to 44 weeks ]

12.  Secondary:   BMI   [ Time Frame: baseline ]

13.  Secondary:   BMI   [ Time Frame: up to 44 weeks ]

14.  Secondary:   BMI Percentile   [ Time Frame: baseline ]

15.  Secondary:   BMI Percentile   [ Time Frame: up to 44 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Katharine Loeb, PhD
Organization: Icahn School of Medicine at Mount Sinai
phone: 212-659-8724
e-mail: Katharine.Loeb@mssm.edu



Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00807560     History of Changes
Other Study ID Numbers: GCO 07-0216
1R21HD057394-01 ( U.S. NIH Grant/Contract )
First Submitted: December 11, 2008
First Posted: December 12, 2008
Results First Submitted: March 4, 2014
Results First Posted: January 8, 2016
Last Update Posted: January 8, 2016



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