Psychopathology, Disordered Eating, and Impulsivity as Predictors of Outcomes of Bariatric Surgery

NCT02775071 | Completed Results DMC

• 1 other identifier: 823735
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the relationship between psychopathology, disordered eating, and impulsivity (measured by clinical interview, self-report measures, and objective testing) on changes in weight and psychosocial status in the first two years after bariatric surgery. Participants will be 300 adults who plan to undergo bariatric surgery. Participants will complete four assessments over a two-year period, one at baseline (before surgery) and 6, 12, and 24 months after surgery. Each assessment will include computer tasks, surveys, clinical interview, urine test, waist circumference and height/weight measurement. The investigators will track how psychopathology, disordered eating, and impulsivity are related to changes in weight and psychosocial status following bariatric surgery.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Percent Weight Change

  percent weight change from baseline

  6, 12, 24 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the Bariatric Surgery Programs at the Hospital of the University of Pennsylvania and Presbyterian Medical Center, all part of Penn Medicine. The investigators will enroll participants until a total of 300 adults have completed baseline visits. Based on the investigator's previous studies of bariatric surgery patients, the investigators expect that approximately 80% of participants will be women and 20% of participants will be ethnic minorities.

You may qualify if:

• Adults aged 18-65 years old 18 years of age or above
• BMI of 35-60 kg/m2 (35 kg/m2 in the presence of significant weight-related comorbidities, including established coronary artery disease, established peripheral arterial disease, symptomatic carotid artery disease, sleep apnea, metabolic syndrome, cardiomyopathy, hypertension, and debilitating joint pain).

You may not qualify if:

• Uncontrolled hypertension (systolic blood pressure 160 or diastolic blood pressure 100mmHg)
• HbA1c 11%
• Recent history of cardiovascular disease (myocardial infarction or stroke within the past 6 months)
• Clinically significant hepatic or renal disease Long-term treatment with oral steroids
• Current use of weight loss medication (OTC or prescription)
• Psychiatric hospitalization in the past 6 months
• Psychiatric diagnosis that would contraindicate surgery (e.g., schizophrenia)
• History of bariatric surgery
• Non-ambulatory individuals, defined as those who are unable to walk without a cane or walker
• Lack of capacity to provide informed consent
• Plans to relocate from the area within 2 years
• Principal Investigator discretion
• For the cognitive, computer-based testing:
• Any impairment (physical and/or neurological) including visual or other impairment preventing cognitive task performance
• Hearing impairment, significant hearing loss (more than 20% in either ear), cochlear implants, or bi-lateral hearing aids (will be assessed on a case-by-case basis to determine whether participants are eligible to complete the Stop Signal Task)

Sponsors & Collaborators

• University of Pennsylvania: lead
• Temple University: collaborator

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: David Sarwer
• Organization: Temple University

dsarwer@temple.edu

215-707-8632

Study Officials

• Kelly C Allison, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 17, 2016
• Study Start: March 3, 2016
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 16, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share