Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Donaghue Medical Research Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a research study designed to examine the effectiveness of an obesity medication (orlistat) given in addition to behavioral weight loss therapy. Participants will be obese monolingual (Spanish-speaking only) men and women.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Xenical + behavioral intervention |
|
| 2 | Active Comparator | Placebo + behavioral intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenical + behavioral intervention | Drug | 120 mg TID; Behavioral weight loss in Spanish |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant BMI | Body Mass Index (BMI) | 4 months and 6 month follow-up |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carlos M Grilo, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hispanic Clinic of the Connecticut Mental Health Center | New Haven | Connecticut | 06511 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34582624 | Derived | Grilo CM, Kerrigan SG, Lydecker JA, White MA. Physical activity changes during behavioral weight loss treatment by Latinx patients with obesity with and without binge eating disorder. Obesity (Silver Spring). 2021 Dec;29(12):2026-2034. doi: 10.1002/oby.23278. Epub 2021 Sep 28. | |
| 23376451 | Derived | Grilo CM, White MA. Orlistat with behavioral weight loss for obesity with versus without binge eating disorder: randomized placebo-controlled trial at a community mental health center serving educationally and economically disadvantaged Latino/as. Behav Res Ther. 2013 Mar;51(3):167-75. doi: 10.1016/j.brat.2013.01.002. Epub 2013 Jan 18. |
Not provided
Not provided
Not provided
The study enrolled participants from August 2007 through October 2009. Participants were a consecutive series of 79 monolingual (Spanish-speaking-only) obese Latino/as recruited from clinical teams and referrals at a community mental health center serving economically disadvantaged persons with mental health needs.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Xenical + Behavioral Intervention | Drug: Xenical + Behavioral: behavioral intervention Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish |
| FG001 | Placebo + Behavioral Intervention | Drug: Placebo + Behavioral: behavioral intervention Behavioral intervention + placebo : Behavioral weight loss treatment in Spanish Placebo three times a day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Total Enrollment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participant BMI | Body Mass Index (BMI) | Data for all randomized participants were included. In the event of dropout or missing data, baseline values were used. | Posted | Mean | Standard Deviation | kg/m^2 | 4 months and 6 month follow-up |
|
Adverse event data were collected for the duration of the trial (through 4 months of active treatment).
Overall frequency of reported side effects was only slightly higher for Xenical than for placebo, although reports of minor gastrointestinal events known to be due to Xenical's mechanism of action were higher for the Xenical condition. Nearly all events occurred early in treatment, were generally mild, and resolved spontaneously.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Drug: Xenical + Behavioral: Behavioral Intervention | Xenical + behavioral intervention Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carlos Grilo | Yale University School of Medicine | 203-785-2792 | carlos.grilo@yale.edu |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D002032 | Bulimia |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077403 | Orlistat |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Behavioral intervention + placebo | Behavioral | Behavioral weight loss treatment in Spanish Placebo TID |
|
| Yale Department of Psychiatry |
| New Haven |
| Connecticut |
| 06519 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Drug: Placebo + Behaviora: Behavioral Intervention | Placebo + behavioral intervention Behavioral intervention + placebo three times a day: Behavioral weight loss treatment in Spanish Placebo TID | 0 | 39 | 0 | 39 |
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |