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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
Enrollment 191
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Care Stepped-care
Hide Arm/Group Description

Standard Care

Behavioral Weight Loss: weekly individual sessions for 6 months

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

Period Title: Overall Study
Started 39 152
Completed 32 127
Not Completed 7 25
Reason Not Completed
Lost to Follow-up             7             25
Arm/Group Title Standard Care Stepped-care Total
Hide Arm/Group Description

Standard Care

Behavioral Weight Loss: weekly individual sessions for 6 months

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 of all reporting groups
Overall Number of Baseline Participants 39 152 191
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 152 participants 191 participants
50.0  (9.2) 48.0  (9.6) 48.4  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 152 participants 191 participants
Female
32
  82.1%
104
  68.4%
136
  71.2%
Male
7
  17.9%
48
  31.6%
55
  28.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants 152 participants 191 participants
White 30 120 150
Black 5 23 28
Hispanic 3 5 8
Asian 1 1 2
Other 0 3 3
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 39 participants 152 participants 191 participants
37.5  (5.7) 39.4  (6.0) 38.9  (5.9)
1.Primary Outcome
Title Number of Subjects Who Reached Binge Eating Remission
Hide Description Binge Remission (abstinence from binge eating)
Time Frame 12 months follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care Stepped-care
Hide Arm/Group Description:

Standard Care

Behavioral Weight Loss: weekly individual sessions for 6 months

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

Overall Number of Participants Analyzed 39 152
Measure Type: Number
Unit of Measure: participants
16 65
2.Secondary Outcome
Title BMI
Hide Description The body mass index is a value derived from the mass and height of an individual. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m^2.
Time Frame 12 months follow-up post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care Stepped-care
Hide Arm/Group Description:

Standard Care

Behavioral Weight Loss: weekly individual sessions for 6 months

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

Overall Number of Participants Analyzed 32 127
Mean (Standard Deviation)
Unit of Measure: kg/m^2
35.9  (6.6) 37.1  (6.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Care Stepped-care
Hide Arm/Group Description

Standard Care

Behavioral Weight Loss: weekly individual sessions for 6 months

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

All-Cause Mortality
Standard Care Stepped-care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Care Stepped-care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/152 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard Care Stepped-care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/152 (0.00%) 
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
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