Loss of Control EatingNCT02259322
Loss of Control Eating Following Weight Loss Surgery
A study testing Standard-of-Care, Behavioral Weight Loss Treatment and Cognitive Behavioral Therapy in people with Loss of Control Eating, run by Yale University at 1 site in United States.
Trial summary
This study will test the effectiveness of two distinct behavioral treatments for loss of control eating following bariatric surgery: 1. Behavioral Weight Loss Treatment 2. Cognitive Behavioral Therapy These treatments will be compared to Standard-of-Care. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Loss of Control Eating
- What is being tested?
- Standard-of-Care, Behavioral Weight Loss Treatment and Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gastric bypass surgery or sleeve gastrectomy patients from Yale Bariatric/Gastrointestinal Surgery Program
- 5-8 months post-bariatric surgery
- Regular loss of control eating (once weekly during past month)
- Read English proficiently enough to read patient self-care materials and study assessments
- Available for duration of treatment plus follow-up period
- Agree to study procedures
Who cannot join
- Current enrollment in a formal exercise program
- Medical status judged by the surgeon as contraindication (rare instances of need for additional surgery or medical instability)
- Unable to ambulate
- Current medications that influence eating/weight
- Current substance dependence or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Department of Psychiatry
New Haven, Connecticut, 06510
About this study
Official title: Treatment of Loss of Control Eating Following Bariatric Surgery
This study will test the effectiveness of two distinct behavioral treatments for loss of control eating following bariatric surgery:
- Behavioral Weight Loss Treatment
- Cognitive Behavioral Therapy
These treatments will be compared to Standard-of-Care.
- Conditions
- Loss of Control Eating
- Being tested
- Standard-of-Care, Behavioral Weight Loss Treatment, Cognitive Behavioral Therapy
- Keywords
- Bariatric surgery, Weight loss surgery, Behavioral weight loss treatment, Cognitive behavioral therapy, Behavioral treatment, Obesity, Morbid obesity, Binge eating, Binge eating disorder, Loss of control eating, Overeating
- Medical subject headings
- Obesity, Obesity, Morbid, Bulimia, Binge-Eating Disorder, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard-of-CareBehavioural
Standard-of-Care with bariatric team. Participants will be encouraged to continue their care with their bariatric team.
Behavioral Weight Loss TreatmentBehavioural
Biweekly individual guided self-help sessions for 3 months
Cognitive Behavioral TherapyBehavioural
Biweekly individual guided self-help sessions for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-Care | Active comparator | Standard-of-care is the continuation of any treatment or recommendations participants receive from his/her bariatric surgeon/team. Receives: Behavioral: Standard-of-Care |
| Behavioral Weight Loss Treatment | Experimental | Guided self-help Behavioral Weight Loss Treatment Receives: Behavioral: Behavioral Weight Loss Treatment |
| Cognitive Behavioral Therapy | Experimental | Guided self-help Cognitive Behavioral Therapy Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of Control Eating Frequency (Categorical)
Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency is defined categorically (presence or absence of loss of control eating).
Measured: Post-treatment (at 3 months)
Loss of Control Eating Frequency (Categorical)
Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency is defined categorically (presence or absence of loss of control eating).
Measured: 24 month follow-up (an average of 24 months following treatment)
Loss of Control Eating Frequency (Continuous)
Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).
Measured: Post-treatment (at 3 months)
Loss of Control Eating Frequency (Continuous)
Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).
Measured: 24 month follow-up (an average of 24 months following treatment)
Body Mass Index (BMI)
BMI is calculated using measured height and weight.
Measured: Post-treatment (at 3 months)
Body Mass Index (BMI)
BMI is calculated using measured height and weight.
Measured: 24 month follow-up (an average of 24 months following treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Loss of Control EatingStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos M Grilo, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259322
- Sponsor's protocol ID
- 1205010224
- Other IDs
- R01DK098492-01A1
- Status last verified
- Aug 2022
- First submitted
- 29 Sep 2014
- Last updated
- 15 Aug 2022
- Results posted
- No
Publications
Lawson JL, Wiedemann AA, Carr MM, Ivezaj V, Duffy AJ, Grilo CM. Examining Sleep Quality Following Sleeve Gastrectomy Among Patients with Loss-of-Control Eating. Obes Surg. 2019 Oct;29(10):3264-3270. doi: 10.1007/s11695-019-03981-7.
PubMed 31197602
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Loss of Control Eating Following Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02259322
- Acronym / sponsor ID
- 1205010224
- Conditions
- Loss of Control Eating
- Keywords
- Bariatric surgery, Weight loss surgery, Behavioral weight loss treatment, Cognitive behavioral therapy, Behavioral treatment, Obesity, Morbid obesity, Binge eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2014
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the effectiveness of two distinct behavioral treatments for loss of control eating following bariatric surgery:
- Behavioral Weight Loss Treatment
- Cognitive Behavioral Therapy
These treatments will be compared to Standard-of-Care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard-of-Care | Active comparator | Behavioral: Standard-of-CareStandard-of-care is the continuation of any treatment or recommendations participants receive from his/her bariatric surgeon/team. |
| Behavioral Weight Loss Treatment | Experimental | Behavioral: Behavioral Weight Loss TreatmentGuided self-help Behavioral Weight Loss Treatment |
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyGuided self-help Cognitive Behavioral Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Gastric bypass surgery or sleeve gastrectomy patients from Yale Bariatric/Gastrointestinal Surgery Program
- 5-8 months post-bariatric surgery
- Regular loss of control eating (once weekly during past month)
- Read English proficiently enough to read patient self-care materials and study assessments
- Available for duration of treatment plus follow-up period
Key exclusion criteria (5 listed)
- Current enrollment in a formal exercise program
- Medical status judged by the surgeon as contraindication (rare instances of need for additional surgery or medical instability)
- Unable to ambulate
- Current medications that influence eating/weight
- Current substance dependence or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment
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 |
|---|---|---|
| Standard-of-CareStandard-of-Care with bariatric team. Participants will be encouraged to continue their care with their bariatric team. | Behavioural | Standard-of-Care |
| Behavioral Weight Loss TreatmentBiweekly individual guided self-help sessions for 3 months | Behavioural | Behavioral Weight Loss Treatment |
| Cognitive Behavioral TherapyBiweekly individual guided self-help sessions for 3 months | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
Loss of Control Eating Frequency (Categorical)
Time frame: Post-treatment (at 3 months)
Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency is defined categorically (presence or absence of loss of control eating).
Loss of Control Eating Frequency (Categorical)
Time frame: 24 month follow-up (an average of 24 months following treatment)
Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency is defined categorically (presence or absence of loss of control eating).
Loss of Control Eating Frequency (Continuous)
Time frame: Post-treatment (at 3 months)
Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).
Loss of Control Eating Frequency (Continuous)
Time frame: 24 month follow-up (an average of 24 months following treatment)
Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).
Body Mass Index (BMI)
Time frame: Post-treatment (at 3 months)
BMI is calculated using measured height and weight.
Body Mass Index (BMI)
Time frame: 24 month follow-up (an average of 24 months following treatment)
BMI is calculated using measured height and weight.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Derived from this study: PubMed 31197602Lawson JL, Wiedemann AA, Carr MM, Ivezaj V, Duffy AJ, Grilo CM. Examining Sleep Quality Following Sleeve Gastrectomy Among Patients with Loss-of-Control Eating. Obes Surg. 2019 Oct;29(10):3264-3270. doi: 10.1007/s11695-019-03981-7.
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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, Ph.D. 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 Standard-of-Care, Behavioral Weight Loss Treatment and Cognitive Behavioral Therapy in people with Loss of Control 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 6 inclusion and 5 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 15 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Loss of Control Eating Frequency (Categorical) (time frame: Post-treatment (at 3 months)). The study lists 6 primary outcomes in all. 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 NCT02259322, which also lists 1 linked publication.
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 15 Aug 2022.