NCT04034017

Brief Summary

Background: Gastroesophageal reflux disease (GERD) is a worldwide prevalent gastrointestinal disorder which has negative impacts on quality of life, health and economy. The aims of this study were to assess the prevalence of GERD among college students in southwestern Saudi Arabia and to evaluate its personal, academic and stress correlates Materials and Methods: Through a cross-sectional study design, a self-reported questionnaire was distributed between a representative sample of students in health and non-health care colleges in southwestern Saudi Arabia. The questionnaire included data for personal characteristics, academic study, and Arabic versions of GERD questionnaire (GerdQ) and Cohen's Perceived Stress Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,878

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2019

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

9 months

First QC Date

July 23, 2019

Last Update Submit

July 24, 2019

Conditions

Keywords

College studentsGastroesophageal reflux diseaseGERDPrevalencePerceived stress

Outcome Measures

Primary Outcomes (4)

  • prevalence rate of gastroesophogeal reflux disease (GERD) among college students

    Arabic version of GERD questionnaire (GerdQ) was used to screen for GERD among college students. GERD was considered with a total score value of GerdQ of 8 or more

    1 year

  • assess the association of GERD with students' personal data

    examining the associations of GERD with the personal data such as, age (in years) sex (male Vs. female), marital status (married Vs. single), smoking status (smoker, ex-smoker and non-smoker) and family income (sufficient Vs. insufficient)

    1 year

  • assess the association of GERD with students' academic data

    the academic data include: college(health care Vs. non-health care colleges) academic year (first year through six year) student's Grade point average (GPA) in the previous academic year

    1 year

  • examine the association of GERD with the level of perceived stress

    perceived stress was assessed by using the Arabic version of Cohen's Perceived Stress Scale (PSS). Grading of PSS into low, moderate and high was done as the following: scores ranging from 0-13 was considered low stress; scores ranging from 14-26 was considered moderate stress; scores ranging from 27-40 was considered high perceived stress.

    1 year

Interventions

descriptive study, no intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

A representative sample of Students in Health and non-health care colleges in King Khalid U

You may qualify if:

  • College students
  • Must be cooperative
  • Agree to participate

You may not qualify if:

  • non cooperative students
  • disagree to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Khalid University

Abhā, 'Asir Region, 61421, Saudi Arabia

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 23, 2019

First Posted

July 26, 2019

Study Start

September 1, 2018

Primary Completion

June 1, 2019

Study Completion

July 18, 2019

Last Updated

July 26, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations