Obesity, Binge Eating
Conditions
Keywords
Experimental, Comparator
Brief summary
This controlled study will test the effectiveness of a stepped-care approach to a standard behavioral weight loss treatment for obese patients with Binge Eating Disorder (BED). The major question is whether the stepped-care approach, which begins with behavioral weight loss and then follows a decision tree for additional interventions based on early treatment response is superior to standard behavioral treatment.
Detailed description
The stepped-care arm of this study included an obesity medication intervention. At the start of the study, the active medication was sibutramine and was compared to a placebo control. On 10/8/2010, Abbott Laboratories withdrew their obesity drug sibutramine (Meridia) from the market in light of clinical trial data pointing to an increased risk for stroke and myocardial infarction. In response to this event, the investigators submitted an IRB amendment to change the active obesity medication from sibutramine to Orlistat. The IRB amendment was approved on 11/4/2010. The PI received approval from NIH/NIDDK Program Officer Robert Kuczmarski to enact this change.
Interventions
BEHAVIORALBehavioral Weight Loss
weekly individual sessions for 6 months
BEHAVIORALBehavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy
weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months
DRUGPlacebo
One pill daily
DRUGSibutramine/Orlistat
Sibutramine 15 mg daily or Orlistat 120mg TID
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Obese (BMI\>=30)
Exclusion criteria
* Medication regimen that represents medical contraindication to sibutramine * Serious unstable or uncontrolled medical conditions that represent contraindication to sibutramine * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Reached Binge Eating Remission | 12 months follow-up | Binge Remission (abstinence from binge eating) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI | 12 months follow-up post-treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Care Standard Care
Behavioral Weight Loss: weekly individual sessions for 6 months | 39 |
| 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 | 152 |
| Total | 191 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 25 |
Baseline characteristics
| Characteristic | Standard Care | Stepped-care | Total |
|---|---|---|---|
| Age, Continuous | 50.0 years STANDARD_DEVIATION 9.2 | 48.0 years STANDARD_DEVIATION 9.6 | 48.4 years STANDARD_DEVIATION 9.5 |
| BMI | 37.5 kg/m^2 STANDARD_DEVIATION 5.7 | 39.4 kg/m^2 STANDARD_DEVIATION 6 | 38.9 kg/m^2 STANDARD_DEVIATION 5.9 |
| Race/Ethnicity, Customized Asian | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Black | 5 participants | 23 participants | 28 participants |
| Race/Ethnicity, Customized Hispanic | 3 participants | 5 participants | 8 participants |
| Race/Ethnicity, Customized Other | 0 participants | 3 participants | 3 participants |
| Race/Ethnicity, Customized White | 30 participants | 120 participants | 150 participants |
| Sex: Female, Male Female | 32 Participants | 104 Participants | 136 Participants |
| Sex: Female, Male Male | 7 Participants | 48 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 39 | 0 / 152 |
| serious Total, serious adverse events | 0 / 39 | 0 / 152 |
Outcome results
Primary
Number of Subjects Who Reached Binge Eating Remission
Binge Remission (abstinence from binge eating)
Time frame: 12 months follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care | Number of Subjects Who Reached Binge Eating Remission | 16 participants |
| Stepped-care | Number of Subjects Who Reached Binge Eating Remission | 65 participants |
Secondary
BMI
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | BMI | 35.9 kg/m^2 | Standard Deviation 6.6 |
| Stepped-care | BMI | 37.1 kg/m^2 | Standard Deviation 6.7 |