Psychosocial Issues and Bariatric Surgery

Obesity Clinical Trial

— LABS3  

Official title:

Psychosocial Issues and Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02495142
• Other study ID #: 5R01DK084979-06
• Status: Completed
• Start date: July 2010
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2019
• Source: Neuropsychiatric Research Institute, Fargo, North Dakota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Other known NCT identifiers

• NCT00582595

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Depressive Disorder
• Disease
• Eating Disorders
• Feeding and Eating Disorders
• Obesity

Locations

Country	Name	City	State
United States	Neuropsychiatric Research Institute	Fargo	North Dakota

Sponsors (4)

Lead Sponsor	Collaborator
Neuropsychiatric Research Institute, Fargo, North Dakota	Columbia University, Duquesne University, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Affect regulation as measured by the DERS	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.	7 year post bariatric surgery
Other	Affect regulation as measured by the AIM	Affect Intensity Measure:The AIM is a 40-item self-report measure of positive and negative emotional intensity and reactivity.	7 years post bariatric surgery
Other	Impulsivity	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.	7 years post bariatric surgery
Other	Behavioral inhibition as measured by the SPSRQ	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.	7 years post bariatric surgery
Other	Temperament as measured by the ATQ	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).	7 years post bariatric surgery
Other	Cognitive Control as measured by the Go/No-Go Task	Go/No-Go Task: This computerized task assesses the capacity for suppressing previously reinforced responses.	7 years post bariatric surgery
Other	Cognitive Control as measured by the Delay Discounting Task	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.	7 years post bariatric surgery
Primary	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.	annually up to 7 years post bariatric surgery
Secondary	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.	annually up to 7 years post bariatric surgery
Secondary	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.	annually up to 7 years post bariatric surgery
Secondary	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.	annually up to 7 years post bariatric surgery
Secondary	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.	annually up to 7 years post bariatric surgery
Secondary	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.	annually up to 7 years post bariatric surgery