Eating Disorders, Overweight
Conditions
Keywords
Binge Eating, Orlistat, Alli, Guided Self-Help
Brief summary
This study will evaluate the effectiveness of adding guided self-help group therapy to a weight loss program in achieving weight loss and reducing binge eating in overweight binge eaters.
Detailed description
Binge eating disorder is one of the most common eating disorders, with more than 4 million Americans affected. Following a binge eating episode, in which a person eats an excessive amount of food in a short period of time, the person often experiences feelings of guilt, depression, embarrassment, and disgust. Beyond the emotional distress caused by binge eating, people who binge eat are at a higher risk for more serious health problems associated with weight gain. These health problems may include high blood pressure, diabetes, heart disease, high cholesterol, and certain types of cancer. Thus, seeking effective treatment for binge eating disorder is vital to an affected person's overall physical and mental well-being. Managed weight loss programs, combined with certain forms of psychotherapy, have shown success in providing the direction and proper motivation to eat healthily and to prevent future binge eating episodes. This study will evaluate the effectiveness of adding guided self-help group therapy to the alli weight loss program in achieving weight loss and reducing binge eating in overweight binge eaters. Participation in this single-blind study will last 36 weeks. Initial assessments will be divided over two 1- to 2-hour sessions. These assessments will include a history of any medical illness, height and weight measurements, and an eating disorder evaluation. Participants will also answer several questionnaires about self-esteem, feelings of depression, and emotion and eating. Participants will then be randomly assigned to one of two treatment groups: the alli program with the use of the weight loss drug orlistat or the alli program with the use of orlistat plus guided self-help group psychotherapy. All participants will take the over-the-counter weight loss medication orlistat three times a day for 12 weeks in conjunction with the alli program, a comprehensive weight loss program with online access. Participants assigned to the psychotherapy group will also attend 12 weekly guided self-help group psychotherapy sessions. These sessions will include behavioral support for adapting to the lifestyle changes promoted by the alli weight loss program. All participants will undergo 12 weeks of active participation, 18 weeks of maintenance, and 18 weeks of follow-up. At various intervals during the first 6 months of the study, participants will answer a short group of questions concerning current binge eating habits; adherence to prescribed food, activity, and medication plan; and emotional state. The initial assessments will be repeated at Weeks 12, 30, and 42.
Interventions
BEHAVIORALEmotion regulation group therapy
Emotion regulation guided self-help group therapy involves twelve 2-hour sessions of guided self-help group psychotherapy.
DRUGOrlistat/alli program
The orlistat/alli program involves taking 60 mg orlistat three times a day and participating in the alli program, a comprehensive behavioral weight loss program with online access.
Sponsors
National Institute of Mental Health (NIMH)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Body mass index greater than 27 * Binge eating at least two times per week during the 6 months prior to study entry
Exclusion criteria
* Current psychosis * Current suicidal ideations * Pregnant * Receiving concurrent psychotherapy * Unstable on psychotropic medications for 3 months prior to study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss | 3 months: Measured from pre to post treatment | Change in weight in lbs from per to post treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binge Frequency | 3 months: Measured from pre to post treatment | frequency of objective binge days over prior 28 days |
Other
| Measure | Time frame |
|---|---|
| Weeks of Adherence to Orlistat | Number of adherent weeks over 1 year study |
Countries
United States
Participant flow
Recruitment details
Participants were recruited through newspaper advertisements and flyers. The study took place at an outpatient psychiatry department of a large university medical center.
Pre-assignment details
There was no wash out, run-in, or transition following participant enrollment.Exclusion criteria are described previously. Main exclusion was weight less than 27 kg/m2.
Participants by arm
| Arm | Count |
|---|---|
| OTC Orlistat + Guided Self-help Affect Regulation Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy | 8 |
| OTC Orlistat /Medication Management Alone Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone | 9 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 5 |
Baseline characteristics
| Characteristic | OTC Orlistat /Medication Management Alone | OTC Orlistat + Guided Self-help Affect Regulation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 8 Participants | 17 Participants |
| Age Continuous | 50.1 years STANDARD_DEVIATION 4.1 | 48.6 years STANDARD_DEVIATION 11.2 | 49.4 years STANDARD_DEVIATION 11.4 |
| Region of Enrollment United States | 9 participants | 8 participants | 17 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 9 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 |
Outcome results
Primary
Weight Loss
Change in weight in lbs from per to post treatment
Time frame: 3 months: Measured from pre to post treatment
Population: Used intent-to-treat analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OTC Orlistat + Guided Self-help Affect Regulation | Weight Loss | 6.15 lbs | Standard Deviation 14.36 |
| OTC Orlistat /Medication Management Alone | Weight Loss | 3.61 lbs | Standard Deviation 8.11 |
Secondary
Binge Frequency
frequency of objective binge days over prior 28 days
Time frame: 3 months: Measured from pre to post treatment
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OTC Orlistat + Guided Self-help Affect Regulation | Binge Frequency | 9.0 % change objective binge days | Standard Deviation 2.13 |
| OTC Orlistat /Medication Management Alone | Binge Frequency | 12.11 % change objective binge days | Standard Deviation 5.44 |
Other Pre-specified
Weeks of Adherence to Orlistat
Time frame: Number of adherent weeks over 1 year study
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OTC Orlistat + Guided Self-help Affect Regulation | Weeks of Adherence to Orlistat | 13.8 week of adherence to orlistat | Standard Deviation 17.3 |
| OTC Orlistat /Medication Management Alone | Weeks of Adherence to Orlistat | 20.6 week of adherence to orlistat | Standard Deviation 19.1 |