Gastroesophageal RefluxNCT04034017
Gastroesophageal Reflux Disease Among College Students
An observational study of Gastroesophageal Reflux, run by King Khalid University at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux
- How many people
- 2,878 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Sep 2018to 18 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A representative sample of Students in Health and non-health care colleges in King Khalid U
Who may be able to join
- College students
- Must be cooperative
- Agree to participate
Who cannot join
- non cooperative students
- disagree to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personal, Academic and Stress Correlates of Gastroesophageal Reflux Disease Among College Students in Southwestern Saudi Arabia: A Cross-sectional Study
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.
Read the detailed description
Study design and setting A cross-sectional study was carried out in both male and female campuses of King Khalid University (KKU) during the academic year 2018-2019. The University is located in Aseer region in the southwestern part of Saudi Arabia. The area of Aseer region is about 80.000 square kilometers occupied with more than 1.6 million people. The university comprise 5 health colleges and 24 non-health colleges with a total number of 60.312 male and female students in the academic year 2014-2015.
Target population Students in Health and non-health care colleges in KKU were the target population.
Sample size and sampling method Sample size was estimated by using Epi info program version 7.2 with the anticipated prevalence of GERD symptoms among college students 23.8% [6], 95% confidence level and acceptable margin of error of 2.5%. The calculated cluster size was 1113 students. To account for the possibility of non-response, 1200 students were targeted from each of health and non-health care colleges.
All health care colleges were included in the study. They were colleges of medicine, pharmacy, dentistry, nursing and applied medical science. Five non- health care colleges were selected by random method. They were colleges of education, science, humanities, administrative and financial sciences, and languages and translation. Participants were selected through stratified cluster sampling technique. Within each college, students were stratified by academic level. Within each level a cluster (section or study group) was selected. When possible, all registered students within each cluster were included.
Study tool and data collection A self-reported questionnaire was distributed personally by medical students-during their training in community medicine course- between the participants. The questionnaire includes the following sections: a) personal data such as, age sex, marital status, smoking status and family income; b) academic data which include, name of college, academic level and Grade point average (GPA); c) Arabic version of GERD questionnaire (GerdQ)[10]; d) Arabic version of Cohen's Perceived Stress Scale (PSS) [8].
All incomplete questionnaires were excluded. Arabic version of GERD questionnaire (GerdQ) GerdQ is a valid questionnaire used to explore the probaility of GERD. It is consisted of 6 questions as follow: four positive questions to assess GERD symptoms (heartburn, regurgitation, sleep disturbance related to heartburn and regurgitation and use of medications) and two negative questions (epigastric pain and nausea). Each item rated from 0 to 3 depending on the rate of symptoms over the previous week. GERD was detected with a total score value of 8 or more [10]. Score value of 8 or more plus total score value of 3 or more for the impact questions (sleep disturbance and use of medications) indicted GERD with impact on daily life. The Arabic version of GerdQ was developed and validated for use among Arabic speakers [11].
Data analysis The gained data were entered, revised, and analyzed using SPSS, version 22 software package. Grading of PSS into low, moderate and high was according to Cohen's et al [12]. Crude odds ratio (cOR) and adjusted odds ratio (aOR) were calculated using univariate and multivariable logistic regression analysis respectively. Their 95% confidence intervals (95% CIs) were used to identify significant factors associated with GERD among students.
- Conditions
- Gastroesophageal Reflux
- Being tested
- no intervention
- Keywords
- College students, Gastroesophageal reflux disease, GERD, Prevalence, Perceived stress
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
descriptive study, no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 Sep 2018
- Primary completion1 Jun 2019
- Study completion18 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,878 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Khalid University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabil Awadalla, King Khalid University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034017
- Sponsor's protocol ID
- ECM
- Status last verified
- Jul 2019
- First submitted
- 23 Jul 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personal, Academic and Stress Correlates of Gastroesophageal Reflux Disease Among College Students in Southwestern Saudi Arabia: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04034017
- Acronym / sponsor ID
- ECM
- Conditions
- Gastroesophageal Reflux
- Keywords
- College students, Gastroesophageal reflux disease, GERD, Prevalence, Perceived stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,878 participants (actual)
- Lead sponsor
- King Khalid UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design and setting A cross-sectional study was carried out in both male and female campuses of King Khalid University (KKU) during the academic year 2018-2019. The University is located in Aseer region in the southwestern part of Saudi Arabia. The area of Aseer region is about 80.000 square kilometers occupied with more than 1.6 million people. The university comprise 5 health colleges and 24 non-health colleges with a total number of 60.312 male and female students in the academic year 2014-2015.
Target population Students in Health and non-health care colleges in KKU were the target population.
Sample size and sampling method Sample size was estimated by using Epi info program version 7.2 with the anticipated prevalence of GERD symptoms among college students 23.8% [6], 95% confidence level and acceptable margin of error of 2.5%. The calculated cluster size was 1113 students. To account for the possibility of non-response, 1200 students were targeted from each of health and non-health care colleges.
All health care colleges were included in the study. They were colleges of medicine, pharmacy, dentistry, nursing and applied medical science. Five non- health care colleges were selected by random method. They were colleges of education, science, humanities, administrative and financial sciences, and languages and translation. Participants were selected through stratified cluster sampling technique. Within each college, students were stratified by academic level. Within each level a cluster (section or study group) was selected. When possible, all registered students within each cluster were included.
Study tool and data collection A self-reported questionnaire was distributed personally by medical students-during their training in community medicine course- between the participants. The questionnaire includes the following sections: a) personal data such as, age sex, marital status, smoking status and family income; b) academic data which include, name of college, academic level and Grade point average (GPA); c) Arabic version of GERD questionnaire (GerdQ)[10]; d) Arabic version of Cohen's Perceived Stress Scale (PSS) [8].
All incomplete questionnaires were excluded. Arabic version of GERD questionnaire (GerdQ) GerdQ is a valid questionnaire used to explore the probaility of GERD. It is consisted of 6 questions as follow: four positive questions to assess GERD symptoms (heartburn, regurgitation, sleep disturbance related to heartburn and regurgitation and use of medications) and two negative questions (epigastric pain and nausea). Each item rated from 0 to 3 depending on the rate of symptoms over the previous week. GERD was detected with a total score value of 8 or more [10]. Score value of 8 or more plus total score value of 3 or more for the impact questions (sleep disturbance and use of medications) indicted GERD with impact on daily life. The Arabic version of GerdQ was developed and validated for use among Arabic speakers [11].
Data analysis The gained data were entered, revised, and analyzed using SPSS, version 22 software package. Grading of PSS into low, moderate and high was according to Cohen's et al [12]. Crude odds ratio (cOR) and adjusted odds ratio (aOR) were calculated using univariate and multivariable logistic regression analysis respectively. Their 95% confidence intervals (95% CIs) were used to identify significant factors associated with GERD among students.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A representative sample of Students in Health and non-health care colleges in King Khalid U
Key inclusion criteria (3 listed)
- College students
- Must be cooperative
- Agree to participate
Key exclusion criteria (2 listed)
- non cooperative students
- disagree to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventiondescriptive study, no intervention | Other | – |
Primary outcome
prevalence rate of gastroesophogeal reflux disease (GERD) among college students
Time frame: 1 year
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
assess the association of GERD with students' personal data
Time frame: 1 year
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)
assess the association of GERD with students' academic data
Time frame: 1 year
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
examine the association of GERD with the level of perceived stress
Time frame: 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux, run by King Khalid University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence rate of gastroesophogeal reflux disease (GERD) among college students (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.