ObesityNCT00829283
Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care
A study testing Behavioral Weight Loss, Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy and Sibutramine/Orlistat in people with Obesity and Binge Eating, run by Yale University at 1 site in United States.
Trial summary
This controlled study will test the effectiveness of a stepped-care approach to a standard behavioral weight loss treatment for obese patients with Binge Eating Disorder (BED). The major question is whether the stepped-care approach, which begins with behavioral weight loss and then follows a decision tree for… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Binge Eating
- What is being tested?
- Behavioral Weight Loss, Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy and Sibutramine/Orlistat
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 191 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Nov 2013
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obese (BMI>=30)
Who cannot join
- Medication regimen that represents medical contraindication to sibutramine
- Serious unstable or uncontrolled medical conditions that represent contraindication to sibutramine
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06520
About this study
This controlled study will test the effectiveness of a stepped-care approach to a standard behavioral weight loss treatment for obese patients with Binge Eating Disorder (BED). The major question is whether the stepped-care approach, which begins with behavioral weight loss and then follows a decision tree for additional interventions based on early treatment response is superior to standard behavioral treatment.
Read the detailed description
The stepped-care arm of this study included an obesity medication intervention. At the start of the study, the active medication was sibutramine and was compared to a placebo control. On 10/8/2010, Abbott Laboratories withdrew their obesity drug sibutramine (Meridia) from the market in light of clinical trial data pointing to an increased risk for stroke and myocardial infarction. In response to this event, the investigators submitted an IRB amendment to change the active obesity medication from sibutramine to Orlistat. The IRB amendment was approved on 11/4/2010. The PI received approval from NIH/NIDDK Program Officer Robert Kuczmarski to enact this change.
- Conditions
- Obesity, Binge Eating
- Being tested
- Behavioral Weight Loss, Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy, Placebo, Sibutramine/Orlistat
- Keywords
- Experimental, Comparator
- Medical subject headings
- Obesity, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Weight LossBehavioural
weekly individual sessions for 6 months
Behavioral Weight Loss + Guided self-help Cognitive-behavioral TherapyBehavioural
weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months
PlaceboDrug
One pill daily
Sibutramine/OrlistatDrug
Sibutramine 15 mg daily or Orlistat 120mg TID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Standard Care Receives: Behavioral: Behavioral Weight Loss |
| 2 | Experimental | Stepped-care Receives: Behavioral: Behavioral Weight Loss; Behavioral: Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy; Drug: Placebo; Drug: Sibutramine/Orlistat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Reached Binge Eating Remission
Binge Remission (abstinence from binge eating)
Measured: 12 months follow-up
Secondary outcomes (1)
BMI
The body mass index is a value derived from the mass and height of an individual. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m^2.
Measured: 12 months follow-up post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startNov 2008
- Primary completionNov 2013
- Study completionNov 2013
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos M Grilo, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829283
- Sponsor's protocol ID
- 0610001922
- Other IDs
- R01DK049587
- Status last verified
- Apr 2020
- First submitted
- 26 Jan 2009
- Last updated
- 3 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Grilo CM, Ivezaj V, Gueorguieva R. Overvaluation of shape/weight at posttreatment predicts relapse at 12-month follow-up after successful behaviorally-based treatment of binge-eating disorder. Int J Eat Disord. 2024 May;57(5):1268-1273. doi: 10.1002/eat.24141. Epub 2024 Feb 6.
PubMed 38321617Grilo CM, White MA, Ivezaj V, Gueorguieva R. Randomized Controlled Trial of Behavioral Weight Loss and Stepped Care for Binge-Eating Disorder: 12-Month Follow-up. Obesity (Silver Spring). 2020 Nov;28(11):2116-2124. doi: 10.1002/oby.22975. Epub 2020 Sep 27.
PubMed 32985114
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care
- ClinicalTrials.gov ID
- NCT00829283
- Acronym / sponsor ID
- 0610001922
- Conditions
- Obesity, Binge Eating
- Keywords
- Experimental, Comparator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Nov 2008
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 27 Jan 2009 (estimated)
- Results
- Posted 1 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This controlled study will test the effectiveness of a stepped-care approach to a standard behavioral weight loss treatment for obese patients with Binge Eating Disorder (BED). The major question is whether the stepped-care approach, which begins with behavioral weight loss and then follows a decision tree for additional interventions based on early treatment response is superior to standard behavioral treatment.
Detailed description
The stepped-care arm of this study included an obesity medication intervention. At the start of the study, the active medication was sibutramine and was compared to a placebo control. On 10/8/2010, Abbott Laboratories withdrew their obesity drug sibutramine (Meridia) from the market in light of clinical trial data pointing to an increased risk for stroke and myocardial infarction. In response to this event, the investigators submitted an IRB amendment to change the active obesity medication from sibutramine to Orlistat. The IRB amendment was approved on 11/4/2010. The PI received approval from NIH/NIDDK Program Officer Robert Kuczmarski to enact this change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Behavioral Weight LossStandard Care |
| 2 | Experimental | Behavioral: Behavioral Weight Loss, Behavioral: Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy, Drug: Placebo, Drug: Sibutramine/OrlistatStepped-care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obese (BMI>=30)
Key exclusion criteria (3 listed)
- Medication regimen that represents medical contraindication to sibutramine
- Serious unstable or uncontrolled medical conditions that represent contraindication to sibutramine
- Pregnancy
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 |
|---|---|---|
| Behavioral Weight Lossweekly individual sessions for 6 months | Behavioural | 1, 2 |
| Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapyweekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months | Behavioural | 2 |
| PlaceboOne pill daily | Drug | 2 |
| Sibutramine/OrlistatSibutramine 15 mg daily or Orlistat 120mg TID | Drug | 2 |
Primary outcome
Number of Subjects Who Reached Binge Eating Remission
Time frame: 12 months follow-up
Binge Remission (abstinence from binge eating)
1 secondary outcome
BMI
Time frame: 12 months follow-up post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38321617Grilo CM, Ivezaj V, Gueorguieva R. Overvaluation of shape/weight at posttreatment predicts relapse at 12-month follow-up after successful behaviorally-based treatment of binge-eating disorder. Int J Eat Disord. 2024 May;57(5):1268-1273. doi: 10.1002/eat.24141. Epub 2024 Feb 6.
- Derived from this study: PubMed 32985114Grilo CM, White MA, Ivezaj V, Gueorguieva R. Randomized Controlled Trial of Behavioral Weight Loss and Stepped Care for Binge-Eating Disorder: 12-Month Follow-up. Obesity (Silver Spring). 2020 Nov;28(11):2116-2124. doi: 10.1002/oby.22975. Epub 2020 Sep 27.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Weight Loss, Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy and Sibutramine/Orlistat in people with Obesity and Binge Eating, run by Yale University at 1 site 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 1 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 3 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 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2016). 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?
Number of Subjects Who Reached Binge Eating Remission (time frame: 12 months 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 NCT00829283, 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 3 Apr 2020.