Clinical trial NCT02495142: Psychosocial Issues and Bariatric Surgery
Official title: Psychosocial Issues and Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Eating Disorders
Bariatric Surgery Candidate
Depressive Disorder
Lead sponsor: Neuropsychiatric Research Institute, Fargo, North Dakota
Sponsor class: OTHER
Collaborators: name: Columbia University
name: University of Pittsburgh
name: Duquesne University
First posted: 2015-07-13
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Change in Psychopathology as measured by the SCID
timeFrame: annually up to 7 years post bariatric surgery
Secondary outcomes:
measure: Change in Quality of life as measured by the IWQOL
timeFrame: annually up to 7 years post bariatric surgery
measure: Change in Quality of life as measured by the SF-36
timeFrame: annually up to 7 years post bariatric surgery
measure: Change in Depression as measured by the BDI
timeFrame: annually up to 7 years post bariatric surgery
measure: Change in Eating behaviors as measured by the EDE
timeFrame: annually up to 7 years post bariatric surgery
measure: Change in Impulse Control as measured by the SCID-ICD module
timeFrame: annually up to 7 years post bariatric surgery
Other outcomes:
measure: Affect regulation as measured by the DERS
timeFrame: 7 year post bariatric surgery
measure: Affect regulation as measured by the AIM
timeFrame: 7 years post bariatric surgery
measure: Impulsivity
timeFrame: 7 years post bariatric surgery
measure: Behavioral inhibition as measured by the SPSRQ
timeFrame: 7 years post bariatric surgery
measure: Temperament as measured by the ATQ
timeFrame: 7 years post bariatric surgery
measure: Cognitive Control as measured by the Go/No-Go Task
timeFrame: 7 years post bariatric surgery
measure: Cognitive Control as measured by the Delay Discounting Task
timeFrame: 7 years post bariatric surgery
Locations:
city: Fargo
country: United States
facility: Neuropsychiatric Research Institute
state: North Dakota
Study officials:
affiliation: Neuropsychiatric Research Institute
name: James E. Mitchell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.