- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06134336
The Effect of Eating Disorder on Occupational Balance in University Students
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Altındağ
-
Ankara, Altındağ, Turkey, 06050
- Ankara Medipol University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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:
- Having any disability,
- Presence of a chronic disease.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
No interventional or behavioral intervention will be applied.
Only interviews will be conducted through a questionnaire.
|
|
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.
|
No interventional or behavioral intervention will be applied.
Only interviews will be conducted through a questionnaire.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
5 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occupational Balance Questionnaire
Time Frame: 8 minute
|
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.
|
8 minute
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/142
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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