ObesityLABS3NCT02495142
Psychosocial Issues and Bariatric Surgery
An observational study of Obesity and Eating Disorders, run by Neuropsychiatric Research Institute, Fargo, North Dakota at 1 site in United States.
Trial summary
Bariatric surgery is associated with long-term weight loss, as well as short-term improvements in obesity-related medical comorbidities. However, a significant proportion of patients fail to lose sufficient weight, or experience significant weight regain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Eating Disorders, Bariatric Surgery Candidate
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to 30 Jun 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be approached for inclusion into LABS1 and LABS2 at the Sanford Surgery Department, Fargo ND, at the University of Pittsburgh Medical Center and at Cornell/Columbia Medical Center in New York. LABS3 Psychosocial participants will be selected from those individuals participating in LABS1 and LABS2.
Who may be able to join
- Male and female patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon.
- Previous enrollment in LABS-1 and LABS-2.
- BMI at baseline of greater than or equal to 35.
Who cannot join
- Informed consent not obtained
- Type 1 Diabetes Mellitus
- Unlikely to comply with follow-up protocol (ie: geographically inaccessible for study visits)
- Unable to communicate with local study staff
Trial locations and contacts
1 site in 1 country.
United States1 site
Neuropsychiatric Research Institute
Fargo, North Dakota, 58103
About this study
Bariatric surgery is associated with long-term weight loss, as well as short-term improvements in obesity-related medical comorbidities. However, a significant proportion of patients fail to lose sufficient weight, or experience significant weight regain. Although no robust predictors of response have been identified, pilot data that will be presented and reviewed suggest that surgery has profound effects on eating behaviors and psychosocial functioning, and that these factors may affect postoperative weight control.
The present investigation capitalizes on the Longitudinal Assessment of Bariatric Surgery (LABS) consortium to conduct an in-depth examination of the psychosocial aspects of surgery among a geographically, ethnically, and racially diverse sample of men and women undergoing bariatric surgery. This project unites experts in the areas of psychopathology, eating behaviors and quality of life to conduct a naturalistic study using state-of-the-art assessment tools; to document the relationships among psychosocial factors; and to examine psychosocial predictors of surgical outcomes.
Read the detailed description
Primary Objective. Despite the obvious impact of bariatric surgery procedures on intake, no study to date has included a careful assessment of psychological factors, feeding patterns, energy intake and eating problems in this group of patients longitudinally. The Investigators believe that a careful examination of the structure of eating behavior and eating problems (e.g. vomiting) would be very helpful in guiding bariatric surgeons and dieticians who work with this group of patients in terms of dietary advice and recommendations, and with the prediction of eating problems and poor nutrient intake in the subgroup that develops such problems. This study involves prospective assessment of psychosocial outcomes of surgery by adding a supplemental battery to the LABS-2 assessment schedule. Conducting assessments at three of the LABS clinical sites assures the geographic, ethnic, and racial diversity of the sample, and hence enhances the potential to identify a subgroup or subgroups of patients susceptible to poor outcomes after surgery and the generalizability of study results.
This study would also include an evaluation of psychopathological and behavioral variables that might impact on weight loss and weight regain, and psychosocial complications post-operatively, as well as quality of life.
The overall goal of this study is to obtain detailed information that will allow a careful assessment of psychopathology, quality of life and eating behavior pre-surgically and at regular intervals for up to 7 years after the surgical intervention.
The Investigators believe that the instruments and procedures selected will allow a detailed examination of psychopathology, eating pathology and quality of life in detail.
The Investigators believe that the measures and tasks added at year 7 will allow the examination of theories of affect regulation, cognitive control, and reward processing in understanding postsurgical outcomes regarding pathological eating behavior and alcohol/substance use and their shared similarities as well as underlying neurobiological systems.
- Medical subject headings
- Obesity, Feeding and Eating Disorders, Depressive Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psychopathology as measured by the SCID
Structured Clinical Interview for DSM-IV, Patients Edition (SCID) will be administered to assess comorbid Axis I psychopathology.
Measured: annually up to 7 years post bariatric surgery
Secondary outcomes (5)
Change in Quality of life as measured by the IWQOL
Impact of Weight on Quality of Life Questionnaire: This is a 31-item, self-report, obesity-specific quality of life measure that will be utilized to assess quality of life.
Measured: annually up to 7 years post bariatric surgery
Change in Quality of life as measured by the SF-36
ShortForm-36: The SF-36 is a 36-item questionnaire that assesses functioning and quality of life as it relates to health status.
Measured: annually up to 7 years post bariatric surgery
Change in Depression as measured by the BDI
Beck Depression Inventory: The BDI is a 21-item instrument that is widely used to assess depressive symptoms.
Measured: annually up to 7 years post bariatric surgery
Change in Eating behaviors as measured by the EDE
Eating Disorder Examination: The diagnostic version of the EDE will be used as the primary measure of eating behavior and pathology.
Measured: annually up to 7 years post bariatric surgery
Change in Impulse Control as measured by the SCID-ICD module
The impulse control module of the SCID will be administered to assess impulsive/compulsive disorders for participants.
Measured: annually up to 7 years post bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startJul 2010
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
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 ObesityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuropsychiatric Research Institute, Fargo, North Dakota
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, University of Pittsburgh, Duquesne University
- Responsible party
- Sponsor
- Investigators
- James E. Mitchell, MD, Principal investigator, Neuropsychiatric Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495142
- Sponsor's protocol ID
- 5R01DK084979-06
- Acronym
- LABS3
- Status last verified
- Aug 2019
- First submitted
- 6 Jul 2015
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Raatz SK, Johnson LK, Caliquary A, King WC, Kalarchian MA, Devlin MJ, Marcus MD, Mitchell JE. Reported nutrient intake over 7 years after Roux-en-Y gastric bypass in the Longitudinal Assessment of Bariatric Surgery-3 (LABS-3) psychosocial study. Surg Obes Relat Dis. 2020 Aug;16(8):1022-1029. doi: 10.1016/j.soard.2020.04.007. Epub 2020 Apr 22.
PubMed 32418771
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Issues and Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02495142
- Acronym / sponsor ID
- LABS3 / 5R01DK084979-06
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Neuropsychiatric Research Institute, Fargo, North DakotaUniversity, hospital or other
- Collaborators
- Columbia University, University of Pittsburgh, Duquesne University
- Study start
- Jul 2010 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 13 Jul 2015 (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.
Bariatric surgery is associated with long-term weight loss, as well as short-term improvements in obesity-related medical comorbidities. However, a significant proportion of patients fail to lose sufficient weight, or experience significant weight regain. Although no robust predictors of response have been identified, pilot data that will be presented and reviewed suggest that surgery has profound effects on eating behaviors and psychosocial functioning, and that these factors may affect postoperative weight control.
The present investigation capitalizes on the Longitudinal Assessment of Bariatric Surgery (LABS) consortium to conduct an in-depth examination of the psychosocial aspects of surgery among a geographically, ethnically, and racially diverse sample of men and women undergoing bariatric surgery. This project unites experts in the areas of psychopathology, eating behaviors and quality of life to conduct a naturalistic study using state-of-the-art assessment tools; to document the relationships among psychosocial factors; and to examine psychosocial predictors of surgical outcomes.
Detailed description
Primary Objective. Despite the obvious impact of bariatric surgery procedures on intake, no study to date has included a careful assessment of psychological factors, feeding patterns, energy intake and eating problems in this group of patients longitudinally. The Investigators believe that a careful examination of the structure of eating behavior and eating problems (e.g. vomiting) would be very helpful in guiding bariatric surgeons and dieticians who work with this group of patients in terms of dietary advice and recommendations, and with the prediction of eating problems and poor nutrient intake in the subgroup that develops such problems. This study involves prospective assessment of psychosocial outcomes of surgery by adding a supplemental battery to the LABS-2 assessment schedule. Conducting assessments at three of the LABS clinical sites assures the geographic, ethnic, and racial diversity of the sample, and hence enhances the potential to identify a subgroup or subgroups of patients susceptible to poor outcomes after surgery and the generalizability of study results.
This study would also include an evaluation of psychopathological and behavioral variables that might impact on weight loss and weight regain, and psychosocial complications post-operatively, as well as quality of life.
The overall goal of this study is to obtain detailed information that will allow a careful assessment of psychopathology, quality of life and eating behavior pre-surgically and at regular intervals for up to 7 years after the surgical intervention.
The Investigators believe that the instruments and procedures selected will allow a detailed examination of psychopathology, eating pathology and quality of life in detail.
The Investigators believe that the measures and tasks added at year 7 will allow the examination of theories of affect regulation, cognitive control, and reward processing in understanding postsurgical outcomes regarding pathological eating behavior and alcohol/substance use and their shared similarities as well as underlying neurobiological systems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be approached for inclusion into LABS1 and LABS2 at the Sanford Surgery Department, Fargo ND, at the University of Pittsburgh Medical Center and at Cornell/Columbia Medical Center in New York. LABS3 Psychosocial participants will be selected from those individuals participating in LABS1 and LABS2.
Key inclusion criteria (3 listed)
- Male and female patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon.
- Previous enrollment in LABS-1 and LABS-2.
- BMI at baseline of greater than or equal to 35.
Key exclusion criteria (4 listed)
- Informed consent not obtained
- Type 1 Diabetes Mellitus
- Unlikely to comply with follow-up protocol (ie: geographically inaccessible for study visits)
- Unable to communicate with local study staff
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Psychopathology as measured by the SCID
Time frame: annually up to 7 years post bariatric surgery
Structured Clinical Interview for DSM-IV, Patients Edition (SCID) will be administered to assess comorbid Axis I psychopathology.
5 secondary outcomes
Change in Quality of life as measured by the IWQOL
Time frame: annually up to 7 years post bariatric surgery
Change in Quality of life as measured by the SF-36
Time frame: annually up to 7 years post bariatric surgery
Change in Depression as measured by the BDI
Time frame: annually up to 7 years post bariatric surgery
Change in Eating behaviors as measured by the EDE
Time frame: annually up to 7 years post bariatric surgery
Change in Impulse Control as measured by the SCID-ICD module
Time frame: annually up to 7 years post bariatric surgery
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 20 Aug 2019.
- Derived from this study: PubMed 32418771Raatz SK, Johnson LK, Caliquary A, King WC, Kalarchian MA, Devlin MJ, Marcus MD, Mitchell JE. Reported nutrient intake over 7 years after Roux-en-Y gastric bypass in the Longitudinal Assessment of Bariatric Surgery-3 (LABS-3) psychosocial study. Surg Obes Relat Dis. 2020 Aug;16(8):1022-1029. doi: 10.1016/j.soard.2020.04.007. Epub 2020 Apr 22.
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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.
James E. Mitchell, MD principal investigator
Neuropsychiatric Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Eating Disorders, run by Neuropsychiatric Research Institute, Fargo, North Dakota 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 3 inclusion and 4 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 20 Aug 2019. 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?
Change in Psychopathology as measured by the SCID (time frame: annually up to 7 years post bariatric surgery). 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 NCT02495142, 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 20 Aug 2019.