Trial · NCT00601354
Adding Guided Self-Help Group Therapy to the Alli Weight Loss Program in Treating Binge Eating Disorder
NCT00601354, Not applicable, Completed, Stanford University; results first posted 2013-09-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Adding Guided Self-Help Group Therapy to the Alli Weight Loss Program in Treating Binge Eating Disorder. Trials, record NCT00601354. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00601354
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adding Guided Self-Help Group Therapy to the Alli Weight Loss Program in Treating Binge Eating Disorder
- NCT number
- NCT00601354
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 17 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Overweight, Eating Disorders
- Interventions
- Emotion regulation group therapy, Orlistat/alli program
- First posted
- 2008-01-28
- Last updated
- 2013-09-09
- Results first posted
- 2013-09-09
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Weight Loss | 3 months: Measured from pre to post treatment | Change in weight in lbs from per to post treatment |
| Secondary | Binge Frequency | 3 months: Measured from pre to post treatment | frequency of objective binge days over prior 28 days |
| Other | Weeks of Adherence to Orlistat | Number of adherent weeks over 1 year study |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Weight Loss | 3 months: Measured from pre to post treatment | Used intent-to-treat analysis | lbs | MEAN |
| SECONDARY | Binge Frequency | 3 months: Measured from pre to post treatment | Intent to treat | % change objective binge days | MEAN |
| OTHER_PRE_SPECIFIED | Weeks of Adherence to Orlistat | Number of adherent weeks over 1 year study | Intent to treat | week of adherence to orlistat | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Weight Loss | OTC Orlistat + Guided Self-help Affect Regulation | 6.15 | Standard Deviation 14.36 | lbs | |
| Weight Loss | OTC Orlistat /Medication Management Alone | 3.61 | Standard Deviation 8.11 | lbs | |
| Binge Frequency | OTC Orlistat + Guided Self-help Affect Regulation | 9.0 | Standard Deviation 2.13 | % change objective binge days | |
| Binge Frequency | OTC Orlistat /Medication Management Alone | 12.11 | Standard Deviation 5.44 | % change objective binge days | |
| Weeks of Adherence to Orlistat | OTC Orlistat + Guided Self-help Affect Regulation | 13.8 | Standard Deviation 17.3 | week of adherence to orlistat | |
| Weeks of Adherence to Orlistat | OTC Orlistat /Medication Management Alone | 20.6 | Standard Deviation 19.1 | week of adherence to orlistat |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OTC Orlistat + Guided Self-help Affect Regulation | 8 | |
| Overall Study | STARTED | OTC Orlistat /Medication Management Alone | 9 | |
| Overall Study | COMPLETED | OTC Orlistat + Guided Self-help Affect Regulation | 4 | |
| Overall Study | COMPLETED | OTC Orlistat /Medication Management Alone | 4 | |
| Overall Study | NOT COMPLETED | OTC Orlistat + Guided Self-help Affect Regulation | 4 | |
| Overall Study | NOT COMPLETED | OTC Orlistat /Medication Management Alone | 5 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OTC Orlistat + Guided Self-help Affect Regulation | ||
| Total, all-cause mortality | OTC Orlistat /Medication Management Alone | ||
| Total, other adverse events | OTC Orlistat + Guided Self-help Affect Regulation | 0 | 8 |
| Total, other adverse events | OTC Orlistat /Medication Management Alone | 0 | 9 |
| Total, serious adverse events | OTC Orlistat + Guided Self-help Affect Regulation | 0 | 8 |
| Total, serious adverse events | OTC Orlistat /Medication Management Alone | 0 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| K23MH066330 | Dialectical Behavior Therapy and Supportive Therapy for Binge Eating Disorder | SAFER, DEBRA L | STANFORD UNIVERSITY | NATIONAL INSTITUTE OF MENTAL HEALTH | 2003 to 2007 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| OTC Orlistat + Guided Self-help Affect Regulation vs OTC Orlistat /Medication Management Alone: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00601354
GET https://conductscience.org/api/trials/v1/NCT00601354/registered