Psychosocial Issues and Bariatric Surgery (LABS3)

Tracking Information
First Submitted Date	July 6, 2015
First Posted Date	July 13, 2015
Last Update Posted Date	March 29, 2018
Study Start Date	July 2010
Estimated Primary Completion Date	July 2019 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: July 8, 2015)	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.
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT02495142 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: July 8, 2015)	Change in Quality of life as measured by the IWQOL [ Time Frame: annually up to 7 years post bariatric surgery ]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.; Change in Quality of life as measured by the SF-36 [ Time Frame: annually up to 7 years post bariatric surgery ]ShortForm-36: The SF-36 is a 36-item questionnaire that assesses functioning and quality of life as it relates to health status.; Change in Depression as measured by the BDI [ Time Frame: annually up to 7 years post bariatric surgery ]Beck Depression Inventory: The BDI is a 21-item instrument that is widely used to assess depressive symptoms.; Change in Eating behaviors as measured by the EDE [ Time Frame: annually up to 7 years post bariatric surgery ]Eating Disorder Examination: The diagnostic version of the EDE will be used as the primary measure of eating behavior and pathology.; Change in Impulse Control as measured by the SCID-ICD module [ Time Frame: annually up to 7 years post bariatric surgery ]The impulse control module of the SCID will be administered to assess impulsive/compulsive disorders for participants.
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures; (submitted: September 21, 2016)	Affect regulation as measured by the DERS [ Time Frame: 7 year post bariatric surgery ]Difficulties in Emotion Regulation Scale: The DERS is a 36-item self-report questionnaire that assesses six domains of emotion dysregulation and has been found to have acceptable internal consistency as well as adequate test-retest reliability and construct validity.; Affect regulation as measured by the AIM [ Time Frame: 7 years post bariatric surgery ]Affect Intensity Measure:The AIM is a 40-item self-report measure of positive and negative emotional intensity and reactivity.; Impulsivity [ Time Frame: 7 years post bariatric surgery ]UPPS-P Impulsive Behavior Scale: This is a 59-item self-report measure assessing five dimensions of impulsivity. Only the negative urgency and positive urgency subscales will be administered.; Behavioral inhibition as measured by the SPSRQ [ Time Frame: 7 years post bariatric surgery ]Sensitivity to Punishment and Sensitivity to Reward Questionnaire: This is a 44-item self-report measure that is based on Gray's behavioral inhibition and activation motivational systems conceptualization, and assesses sensitivity to punishment and reward.; Temperament as measured by the ATQ [ Time Frame: 7 years post bariatric surgery ]Effortful Control Scale of the Adult Temperament Questionnaire: This 19-item self-report measure assesses several components of dispositional effortful control, including attentional control (i.e., ability to voluntarily focus or shift attention), inhibitory control (i.e., ability to inhibit behavior), and activation control (i.e., ability to activate behavior as needed).; Cognitive Control as measured by the Go/No-Go Task [ Time Frame: 7 years post bariatric surgery ]Go/No-Go Task: This computerized task assesses the capacity for suppressing previously reinforced responses.; Cognitive Control as measured by the Delay Discounting Task [ Time Frame: 7 years post bariatric surgery ]Delay Discounting Task: Delay discounting tasks require participants to choose between receiving a larger amount of money after a delay versus receiving a smaller amount immediately.
Original Other Outcome Measures; (submitted: July 8, 2015)	Affect regulation as measured by the DERS [ Time Frame: 7 year post bariatric surgery ]Difficulties in Emotion Regulation Scale: The DERS is a 36-item self-report questionnaire that assesses six domains of emotion dysregulation and has been found to have acceptable internal consistency as well as adequate test-retest reliability and construct validity.; Affect regulation as measured by the AIM [ Time Frame: 7 years post bariatric surgery ]Affect Intensity Measure:The AIM is a 40-item self-report measure of positive and negative emotional intensity and reactivity.; Impulsivity [ Time Frame: 7 years post bariatric surgery ]UPPS-P Impulsive Behavior Scale: This is a 59-item self-report measure assessing five dimensions of impulsivity. Only the negative urgency and positive urgency subscales will be administered.; Behavioral inhibition as measured by the SPSRQ [ Time Frame: 7 years post bariatric surgery ]Sensitivity to Punishment and Sensitivity to Reward Questionnaire: This is a 44-item self-report measure that is based on Gray's behavioral inhibition and activation motivational systems conceptualization, and assesses sensitivity to punishment and reward.; Temperment as measured by the ATQ [ Time Frame: 7 years post bariatric surgery ]Effortful Control Scale of the Adult Temperament Questionnaire: This 19-item self-report measure assesses several components of dispositional effortful control, including attentional control (i.e., ability to voluntarily focus or shift attention), inhibitory control (i.e., ability to inhibit behavior), and activation control (i.e., ability to activate behavior as needed).; Cognitive Control as measured by the Go/No-Go Task [ Time Frame: 7 years post bariatric surgery ]Go/No-Go Task: This computerized task assesses the capacity for suppressing previously reinforced responses.; Cognitive Control as measured by the Delay Discounting Task [ Time Frame: 7 years post bariatric surgery ]Delay Discounting Task: Delay discounting tasks require participants to choose between receiving a larger amount of money after a delay versus receiving a smaller amount immediately.
Descriptive Information
Brief Title	Psychosocial Issues and Bariatric Surgery
Official Title	Psychosocial Issues and Bariatric Surgery
Brief 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. 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 Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
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.
Condition	Obesity; Eating Disorders; Bariatric Surgery Candidate; Depressive Disorder
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Active, not recruiting
Actual Enrollment; (submitted: July 8, 2015)	202
Original Actual Enrollment	Same as current
Estimated Study Completion Date	July 2019
Estimated Primary Completion Date	July 2019 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: 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. Exclusion Criteria: 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT02495142
Other Study ID Numbers	5R01DK084979-06( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Neuropsychiatric Research Institute, Fargo, North Dakota
Study Sponsor	Neuropsychiatric Research Institute, Fargo, North Dakota
Collaborators	Columbia University; University of Pittsburgh; Duquesne University
Investigators	Principal Investigator: James E. Mitchell, MD Neuropsychiatric Research Institute
PRS Account	Neuropsychiatric Research Institute, Fargo, North Dakota
Verification Date	March 2018