ObesityPhase 4NCT00516919
Study of Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons
A Phase 4 study testing Xenical + behavioral intervention in people with Obesity and Binge Eating, run by Yale University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Binge Eating
- What is being tested?
- Xenical + behavioral intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2007to Dec 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Monolingual Spanish Speaking
- Obese (BMI >= 30)
Who cannot join
- Pregnancy
- Current cardiac disease
- Serious neurologic illnesses
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hispanic Clinic of the Connecticut Mental Health Center
New Haven, Connecticut, 06511
Yale Department of Psychiatry
New Haven, Connecticut, 06519
About this study
Official title: Controlled Trial of Orlistat With Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons
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.
- Conditions
- Obesity, Binge Eating
- Being tested
- Xenical + behavioral intervention, Behavioral intervention + placebo
- Keywords
- Obesity, Binge Eating, Monolingual Hispanic Persons, Orlistat, Behavioral Weight Loss Treatment
- Medical subject headings
- Obesity, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenical + behavioral interventionDrug
Also called Xenical
120 mg TID; Behavioral weight loss in Spanish
Behavioral intervention + placeboBehavioural
Behavioral weight loss treatment in Spanish Placebo TID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Xenical + behavioral intervention Receives: Drug: Xenical + behavioral intervention |
| 2 | Active comparator | Placebo + behavioral intervention Receives: Behavioral: Behavioral intervention + placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant BMI
Body Mass Index (BMI)
Measured: 4 months and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Donaghue Medical Research Foundation
- Responsible party
- Sponsor
- Investigators
- Carlos M Grilo, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516919
- Sponsor's protocol ID
- 0608001753
- Status last verified
- Mar 2020
- First submitted
- 15 Aug 2007
- Last updated
- 2 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 34582624Grilo 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.
PubMed 23376451
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Trial of Orlistat With Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons
- ClinicalTrials.gov ID
- NCT00516919
- Acronym / sponsor ID
- 0608001753
- Conditions
- Obesity, Binge Eating
- Keywords
- Obesity, Binge Eating, Monolingual Hispanic Persons, Orlistat, Behavioral Weight Loss Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Donaghue Medical Research Foundation
- Study start
- Aug 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Aug 2007 (estimated)
- Results
- Posted 7 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Xenical + behavioral interventionXenical + behavioral intervention |
| 2 | Active comparator | Behavioral: Behavioral intervention + placeboPlacebo + behavioral intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Monolingual Spanish Speaking
- Obese (BMI >= 30)
Key exclusion criteria (3 listed)
- Pregnancy
- Current cardiac disease
- Serious neurologic illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xenical + behavioral interventionAlso: Xenical120 mg TID; Behavioral weight loss in Spanish | Drug | 1 |
| Behavioral intervention + placeboBehavioral weight loss treatment in Spanish Placebo TID | Behavioural | 2 |
Primary outcome
Participant BMI
Time frame: 4 months and 6 month follow-up
Body Mass Index (BMI)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34582624Grilo 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.
- Derived from this study: PubMed 23376451Grilo 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.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos M Grilo, PhD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xenical + behavioral intervention in people with Obesity and Binge Eating, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant BMI (time frame: 4 months and 6 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00516919, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.