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Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care

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ClinicalTrials.gov Identifier: NCT00829283
Recruitment Status : Completed
First Posted : January 27, 2009
Results First Posted : February 1, 2016
Last Update Posted : February 1, 2016
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Carlos Grilo, Yale University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Obesity
Binge Eating
Interventions: Behavioral: Behavioral Weight Loss
Behavioral: Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy
Drug: Placebo
Drug: Sibutramine/Orlistat

  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
Standard Care

Standard Care

Behavioral Weight Loss: weekly individual sessions for 6 months

Stepped-care

Stepped-care

Behavioral Weight Loss: weekly individual sessions for 6 months

Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months

Placebo: One pill daily

Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID


Participant Flow:   Overall Study
    Standard Care   Stepped-care
STARTED   39   152 
COMPLETED   32   127 
NOT COMPLETED   7   25 
Lost to Follow-up                7                25 



  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
Standard Care

Standard Care

Behavioral Weight Loss: weekly individual sessions for 6 months

Stepped-care

Stepped-care

Behavioral Weight Loss: weekly individual sessions for 6 months

Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months

Placebo: One pill daily

Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID

Total Total of all reporting groups

Baseline Measures
   Standard Care   Stepped-care   Total 
Overall Participants Analyzed 
[Units: Participants]
 39   152   191 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.0  (9.2)   48.0  (9.6)   48.4  (9.5) 
Gender 
[Units: Participants]
     
Female   32   104   136 
Male   7   48   55 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   30   120   150 
Black   5   23   28 
Hispanic   3   5   8 
Asian   1   1   2 
Other   0   3   3 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 37.5  (5.7)   39.4  (6.0)   38.9  (5.9) 


  Outcome Measures

1.  Primary:   Number of Subjects Who Reached Binge Eating Remission   [ Time Frame: 12 months follow-up ]

2.  Secondary:   BMI   [ Time Frame: 12 months follow-up post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  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

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Carlos Grilo
Organization: Yale School of Medicine
phone: 203-785-2792
e-mail: carlos.grilo@yale.edu



Responsible Party: Carlos Grilo, Yale University
ClinicalTrials.gov Identifier: NCT00829283     History of Changes
Other Study ID Numbers: DK49587
R01DK049587 ( U.S. NIH Grant/Contract )
First Submitted: January 26, 2009
First Posted: January 27, 2009
Results First Submitted: October 27, 2015
Results First Posted: February 1, 2016
Last Update Posted: February 1, 2016