Trial Outcomes & Findings for Adding Guided Self-Help Group Therapy to the Alli Weight Loss Program in Treating Binge Eating Disorder (NCT NCT00601354)

NCT ID: NCT00601354

Last Updated: 2013-09-09

Results Overview

Change in weight in lbs from per to post treatment

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 17 participants
• Primary outcome timeframe: 3 months: Measured from pre to post treatment
• Results posted on: 2013-09-09

Participant Flow

Participants were recruited through newspaper advertisements and flyers. The study took place at an outpatient psychiatry department of a large university medical center.

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.

Participant milestones

Measure	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	OTC Orlistat /Medication Management Alone Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
Overall Study STARTED	8	9
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Measure	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	OTC Orlistat /Medication Management Alone Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
Overall Study Lost to Follow-up	4	5

Baseline Characteristics

Adding Guided Self-Help Group Therapy to the Alli Weight Loss Program in Treating Binge Eating Disorder

Baseline characteristics by cohort

Measure	OTC Orlistat + Guided Self-help Affect Regulation n=8 Participants 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	OTC Orlistat /Medication Management Alone n=9 Participants Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	48.6 years STANDARD_DEVIATION 11.2 • n=5 Participants	50.1 years STANDARD_DEVIATION 4.1 • n=7 Participants	49.4 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	9 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months: Measured from pre to post treatment

Population: Used intent-to-treat analysis

Change in weight in lbs from per to post treatment

Outcome measures

Measure	OTC Orlistat + Guided Self-help Affect Regulation n=8 Participants 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	OTC Orlistat /Medication Management Alone n=9 Participants Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
Weight Loss	6.15 lbs Standard Deviation 14.36	3.61 lbs Standard Deviation 8.11

SECONDARY outcome

Timeframe: 3 months: Measured from pre to post treatment

Population: Intent to treat

frequency of objective binge days over prior 28 days

Outcome measures

Measure	OTC Orlistat + Guided Self-help Affect Regulation n=8 Participants 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	OTC Orlistat /Medication Management Alone n=9 Participants Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
Binge Frequency	9.0 % change objective binge days Standard Deviation 2.13	12.11 % change objective binge days Standard Deviation 5.44

OTHER_PRE_SPECIFIED outcome

Timeframe: Number of adherent weeks over 1 year study

Population: Intent to treat

Outcome measures

Measure	OTC Orlistat + Guided Self-help Affect Regulation n=8 Participants 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	OTC Orlistat /Medication Management Alone n=9 Participants Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
Weeks of Adherence to Orlistat	13.8 week of adherence to orlistat Standard Deviation 17.3	20.6 week of adherence to orlistat Standard Deviation 19.1

Adverse Events

OTC Orlistat + Guided Self-help Affect Regulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

OTC Orlistat /Medication Management Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Debra L Safer

Stanford University

Phone: 650-723-7928

Email: dlsafer@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place