Psychosocial Issues and Bariatric Surgery

NCT02495142 | Completed DMC

• 1 other identifier: 5R01DK084979-06
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Eating Disorders; Bariatric Surgery Candidate; Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Quality of life as measured by the IWQOL

  annually up to 7 years post bariatric surgery

• Change in Quality of life as measured by the SF-36

  annually up to 7 years post bariatric surgery

• Change in Depression as measured by the BDI

  annually up to 7 years post bariatric surgery

• Change in Eating behaviors as measured by the EDE

  annually up to 7 years post bariatric surgery

• Change in Impulse Control as measured by the SCID-ICD module

  annually up to 7 years post bariatric surgery

Other Outcomes (7)

• Affect regulation as measured by the DERS

  7 year post bariatric surgery

• Affect regulation as measured by the AIM

  7 years post bariatric surgery

• Impulsivity

  7 years post bariatric surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuropsychiatric Research Institute, Fargo, North Dakota: lead
• Columbia University: collaborator
• University of Pittsburgh: collaborator
• Duquesne University: collaborator

Study Sites (1)

Neuropsychiatric Research Institute

Fargo, North Dakota, 58103, United States

Location

Related Publications (1)

• 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.

  PMID: 32418771 DERIVED

MeSH Terms

Conditions

Obesity; Feeding and Eating Disorders; Depressive Disorder

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Mental Disorders; Mood Disorders

Study Officials

• James E. Mitchell, MD

  Neuropsychiatric Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: July 13, 2015
• Study Start: July 1, 2010
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: August 20, 2019

Record last verified: 2019-08

Locations

US (1)