N/A N=300

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

Obesity

Bottom Line

View on ClinicalTrials.gov: NCT02775071 ↗

Enrolled (actual)

300

Serious AEs

0.0%

Results posted

May 2024

Primary outcome: Primary: Percent Weight Change — 23.0; 26.2; 23.3 percent weight change

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: Dec 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Weight Change	23.0; 26.2; 23.3	—

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.

Eligibility Criteria

Inclusion Criteria

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).

Exclusion Criteria

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)
Color Blindness (will be assessed on a case-by-case basis to determine whether participants are eligible to complete the Stroop Task)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02775071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.