NCT02775071

Completed

Psychopathology, Disordered Eating, and Impulsivity as Predi...

University of Pennsylvania Source

University of Pennsylvania

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

823735

Study Type

observational

Actual enrollment (reported)

300

Locations

0 countries

Sites

N/A

Timeline

Study Start

March 3, 2016

Actual (reported)

Primary Completion

December 31, 2021

Actual (reported)

Study Completion

December 31, 2021

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 300 participants
Study completion date: December 31, 2021
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 3, 2016
Actual (reported)
First Submitted
May 10, 2016
Actual (reported)
First Posted
May 17, 2016
Actual (reported)
Primary Completion
December 31, 2021
Actual (reported)
Study Completion
December 31, 2021
Actual (reported)
Results Posted
May 16, 2024
Actual (reported)

Last Updated: May 16, 2024
Status Verified: May 2024
Results QC Date: May 7, 2024
Last Update Submitted: May 7, 2024

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

Percent Weight Change
percent weight change from baseline
6, 12, 24 months

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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:

Sponsors & Collaborators

Temple University
Othercollaborator
University of Pennsylvania
Otherlead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title: David Sarwer
Organization: Temple University

Study Officials

Kelly C Allison, PhD
University of Pennsylvania
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

300 participants (actual enrollment reported by the registry).

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

Actual (reported)

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NCT02777177

Ecological Momentary Assessment of Behavioral and Psychosocial Predictors of Weight Loss Following Bariatric Surgery

Completed

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)
+1 more criteria

Contact the study team to confirm eligibility.

Primary Completion

December 31, 2021

Actual (reported)

Study Completion

December 31, 2021

Actual (reported)

Last Updated

May 16, 2024

Results First Posted

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02775071
Data provider: ClinicalTrials.gov
Source updated: 2024-05-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:28 UTC

Documents

Study Protocol and Statistical Analysis Plan
ProtocolSAP2018-10-08
Informed Consent Form
ICF2018-10-25

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents