Overweight Clinical Trial
Official title:
Comparing Orlistat/Alli to Orlistat/Alli Plus Guided Self-help Group Therapy in Overweight Binge Eaters
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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