University StudentNCT06134336
The Effect of Eating Disorder on Occupational Balance in University Students
An observational study of University Student and Eating Disorders, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effect of eating disorders on occupational balance in university students. Occupational balance levels will be compared in university students with and without eating disorders. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- University Student, Eating Disorders, Occupational Balance
- What is being tested?
- Interview
- How many people
- 217 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2023to 30 Aug 2024
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The population of the study will consist of volunteer students between the ages of 18-25 who continue their university education.
Who may be able to join
- Volunteering to participate in the study,
- To be able to read and write Turkish,
- To be between the ages of 18-25 and studying at undergraduate level.
Who cannot join
- Having any disability,
- Presence of a chronic disease.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Medipol University
Ankara, Altındağ, 06050
About this study
The aim of this study is to examine the effect of eating disorders on occupational balance in university students. Occupational balance levels will be compared in university students with and without eating disorders. The study will be finalized with the voluntary participation of 105 university students for both groups and 210 university students in total. The relationship between eating disorder tendencies and occupational balance in university students will be examined.
Read the detailed description
The population of the study will consist of voluntary students between the ages of 18-25 who continue their university education. In the power analysis performed to determine the sample size, it was determined in the G*Power program, with 95% power (alpha = .05, two-way), the effect size was taken as Cohen's d = 0.5 by the guidelines provided by J. Cohen, and it was determined that at least 105 people in each group and 210 people in total were needed for the independent sample t-test.
Inclusion criteria:
- Volunteering to participate in the study,
- To be able to read and write Turkish,
- To be between the ages of 18-25 and studying at undergraduate level
Exclusion criteria:
- Any disability,
- Presence of a chronic disease
Individuals who volunteered to participate in the study will be evaluated with data collection forms filled in through questionnaires. Demographic information about the individuals (such as class, department, age, and gender) will be obtained with the sociodemographic information form. Data collection tools will be used by the researchers in face-to-face interviews with the participants and the data will be recorded anonymously.
It will be determined whether the participants have an eating disorder according to the results of the SCOFF Eating Disorders Scale. Participants with eating disorders will constitute the research group and participants without eating disorders will constitute the control group. Both groups will complete the Occupational Balance Questionnaire and their occupational balances will be compared. The study was planned to be terminated when there were at least 105 participants in each of the research and control groups for the endpoint.
- Conditions
- University Student, Eating Disorders, Occupational Balance
- Being tested
- Interview
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
No interventional or behavioral intervention will be applied. Only interviews will be conducted through a questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Research Group | Participants with eating disorders according to the SCOFF Eating Disorders Scale will constitute the research group. Both groups will complete the Occupational Balance Questionnaire and their occupational balances will be compared. The study will be terminated when there are at least 105 participants in the research and control groups and 210 participants in total. Receives: Other: Interview | |
| Control Group | Participants without eating disorders according to the SCOFF Eating Disorders Scale will constitute the control group. Both groups will complete the Occupational Balance Questionnaire and their occupational balances will be compared. The study will be terminated when there are at least 105 participants in the research and control groups and 210 participants in total. Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCOFF Eating Disorders Scale
The SCOFF Eating Disorders Scale will be used to measure whether the participants have an eating disorder. The Turkish validity and reliability of this scale in university students was conducted by Aydemir et al. in 2015. There are five questions in the scale and the questions are answered as yes/no. One point is given for each question answered as yes, and scores of 2 and above are considered as eating disorders. This scale will be decisive in the inclusion of the participants in the research and control groups.
Measured: 5 minute
Secondary outcomes (1)
Occupational Balance Questionnaire
The Occupational Balance Questionnaire will be used to measure the occupational balance of individuals. This scale defines the concept of occupational balance by measuring the individual's satisfaction with the number and type of activities of daily living. Each item in the scale is a four-point Likert scale ranging from "strongly agree (0)", "disagree (1)", "agree (2)" and "strongly agree (3)". The scores of all items are summed and written as a total score. Scores that can be obtained in the scale vary between 0-33. A high score is characterized as good occupational balance.
Measured: 8 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start10 Nov 2023
- Primary completion30 Jun 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for University StudentStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Kaplan Kilic, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134336
- Sponsor's protocol ID
- 2023/142
- Status last verified
- Mar 2025
- First submitted
- 6 Nov 2023
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Phillips L, Kemppainen JK, Mechling BM, MacKain S, Kim-Godwin Y, Leopard L. Eating disorders and spirituality in college students. J Psychosoc Nurs Ment Health Serv. 2015 Jan;53(1):30-7. doi: 10.3928/02793695-20141201-01. Epub 2014 Dec 10.
PubMed 25490775
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Eating Disorder on Occupational Balance in University Students
- ClinicalTrials.gov ID
- NCT06134336
- Acronym / sponsor ID
- 2023/142
- Conditions
- University Student, Eating Disorders, Occupational Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 18 Nov 2023 (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.
The aim of this study is to examine the effect of eating disorders on occupational balance in university students. Occupational balance levels will be compared in university students with and without eating disorders. The study will be finalized with the voluntary participation of 105 university students for both groups and 210 university students in total. The relationship between eating disorder tendencies and occupational balance in university students will be examined.
Detailed description
The population of the study will consist of voluntary students between the ages of 18-25 who continue their university education. In the power analysis performed to determine the sample size, it was determined in the G*Power program, with 95% power (alpha = .05, two-way), the effect size was taken as Cohen's d = 0.5 by the guidelines provided by J. Cohen, and it was determined that at least 105 people in each group and 210 people in total were needed for the independent sample t-test.
Inclusion criteria:
- Volunteering to participate in the study,
- To be able to read and write Turkish,
- To be between the ages of 18-25 and studying at undergraduate level
Exclusion criteria:
- Any disability,
- Presence of a chronic disease
Individuals who volunteered to participate in the study will be evaluated with data collection forms filled in through questionnaires. Demographic information about the individuals (such as class, department, age, and gender) will be obtained with the sociodemographic information form. Data collection tools will be used by the researchers in face-to-face interviews with the participants and the data will be recorded anonymously.
It will be determined whether the participants have an eating disorder according to the results of the SCOFF Eating Disorders Scale. Participants with eating disorders will constitute the research group and participants without eating disorders will constitute the control group. Both groups will complete the Occupational Balance Questionnaire and their occupational balances will be compared. The study was planned to be terminated when there were at least 105 participants in each of the research and control groups for the endpoint.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Research Group | – | Other: InterviewParticipants with eating disorders according to the SCOFF Eating Disorders Scale will constitute the research group. Both groups will complete the Occupational Balance Questionnaire and their occupational balances will be compared. The study will be terminated when there are at least 105 participants in the research and control groups and 210 participants in total. |
| Control Group | – | Other: InterviewParticipants without eating disorders according to the SCOFF Eating Disorders Scale will constitute the control group. Both groups will complete the Occupational Balance Questionnaire and their occupational balances will be compared. The study will be terminated when there are at least 105 participants in the research and control groups and 210 participants in total. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The population of the study will consist of volunteer students between the ages of 18-25 who continue their university education.
Key inclusion criteria (3 listed)
- Volunteering to participate in the study,
- To be able to read and write Turkish,
- To be between the ages of 18-25 and studying at undergraduate level.
Key exclusion criteria (2 listed)
- Having any disability,
- Presence of a chronic disease.
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 |
|---|---|---|
| InterviewNo interventional or behavioral intervention will be applied. Only interviews will be conducted through a questionnaire. | Other | Control Group, Research Group |
Primary outcome
SCOFF Eating Disorders Scale
Time frame: 5 minute
The SCOFF Eating Disorders Scale will be used to measure whether the participants have an eating disorder. The Turkish validity and reliability of this scale in university students was conducted by Aydemir et al. in 2015. There are five questions in the scale and the questions are answered as yes/no. One point is given for each question answered as yes, and scores of 2 and above are considered as eating disorders. This scale will be decisive in the inclusion of the participants in the research and control groups.
1 secondary outcome
Occupational Balance Questionnaire
Time frame: 8 minute
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 12 Mar 2025.
- Results publication: PubMed 25490775Phillips L, Kemppainen JK, Mechling BM, MacKain S, Kim-Godwin Y, Leopard L. Eating disorders and spirituality in college students. J Psychosoc Nurs Ment Health Serv. 2015 Jan;53(1):30-7. doi: 10.3928/02793695-20141201-01. Epub 2014 Dec 10.
- Related InfoLink provided by the sponsor.
- 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 University Student and Eating Disorders, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 12 Mar 2025. 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 Turkey (Türkiye). 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?
SCOFF Eating Disorders Scale (time frame: 5 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06134336, which also lists 1 linked publication.
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 12 Mar 2025.