NCT06491069

Brief Summary

the goal of this observational study is to Investigate and determine rate of occurrence and associated risk factors of depression , anxiety , eating disorder after bariatric surgery. participants will undergo psychometric tests.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 8, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

11 months

First QC Date

June 14, 2024

Last Update Submit

July 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • risk factors of depression , anxiety and rating disorder after bariatric surgery

    identification of risk factors that lead to occurrence of depression and anxiety and eating disorders in patients who had bariatric surgeris

    baseline

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

the group being investigated is patients who had obesity and underwent Bariatric surgery

You may qualify if:

  • study sample of humans who had bariatric surgery.
  • Subjects with postoperative time of ≥ 3 months
  • Male or female aged between 18:60 years.

You may not qualify if:

  • Illiterate patients.
  • Patients have dementia or psychosis.
  • Age below 18 or above 60 years.
  • Patients refused to give written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Sarwer DB, Allison KC, Wadden TA, Ashare R, Spitzer JC, McCuen-Wurst C, LaGrotte C, Williams NN, Edwards M, Tewksbury C, Wu J. Psychopathology, disordered eating, and impulsivity as predictors of outcomes of bariatric surgery. Surg Obes Relat Dis. 2019 Apr;15(4):650-655. doi: 10.1016/j.soard.2019.01.029. Epub 2019 Feb 23.

    PMID: 30858009BACKGROUND
  • Brown RM, Guerrero-Hreins E, Brown WA, le Roux CW, Sumithran P. Potential gut-brain mechanisms behind adverse mental health outcomes of bariatric surgery. Nat Rev Endocrinol. 2021 Sep;17(9):549-559. doi: 10.1038/s41574-021-00520-2. Epub 2021 Jul 14.

    PMID: 34262156BACKGROUND
  • Ivezaj V, Kessler EE, Lydecker JA, Barnes RD, White MA, Grilo CM. Loss-of-control eating following sleeve gastrectomy surgery. Surg Obes Relat Dis. 2017 Mar;13(3):392-398. doi: 10.1016/j.soard.2016.09.028. Epub 2016 Oct 1.

    PMID: 27913121BACKGROUND
  • undefined

    BACKGROUND
  • Flegal KM, Carroll MD, Kit BK, Ogden CL. Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010. JAMA. 2012 Feb 1;307(5):491-7. doi: 10.1001/jama.2012.39. Epub 2012 Jan 17.

    PMID: 22253363BACKGROUND

MeSH Terms

Conditions

DepressionAnxiety DisordersFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Taher Abdel Raheem Sayed, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 14, 2024

First Posted

July 8, 2024

Study Start

July 15, 2024

Primary Completion

June 15, 2025

Study Completion

July 15, 2025

Last Updated

July 8, 2024

Record last verified: 2024-07