Parent-Based Treatment for Pediatric Overweight (PO)

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00807560
First received: December 11, 2008
Last updated: December 2, 2015
Last verified: December 2015
Results First Received: March 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Overweight
Obesity
Interventions: Behavioral: FBT-PO
Behavioral: NEC

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide Baseline Characteristics

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.
No text entered.

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  
Number of Participants  
[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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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 ( US NIH Grant/Contract Award Number )
Study First Received: December 11, 2008
Results First Received: March 4, 2014
Last Updated: December 2, 2015
Health Authority: United States: Institutional Review Board