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Trial registered on ANZCTR
Registration number
ACTRN12624001161516
Ethics application status
Approved
Date submitted
29/07/2024
Date registered
24/09/2024
Date last updated
24/09/2024
Date data sharing statement initially provided
24/09/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
The Relationships between Intuitive Eating, Mindful Eating, Social Physique Anxiety and Obesity in Adolescents
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Scientific title
The Relationships between Intuitive Eating, Mindful Eating, Social Physique Anxiety and Obesity in Adolescents
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Secondary ID [1]
312641
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
obesity
334607
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social physique anxiety
334827
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Condition category
Condition code
Diet and Nutrition
331192
331192
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0
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Obesity
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Diet and Nutrition
331193
331193
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0
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Other diet and nutrition disorders
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Mental Health
331385
331385
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0
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Anxiety
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This cross-sectional study's sample included adolescents with normal weight and obesity aged 10-19 who were studying in schools affiliated with the Ministry of National Education. Participants were assessed on their eating behaviour once over a 2-hour study visit using some scales. The questionnaire collected data on sociodemographic characteristics, anthropometric measurements, intuitive eating scale scores, mindful eating questionnaire scores and social physique anxiety scale scores. All data anticipated to take 30 minutes to complete.
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Intervention code [1]
329160
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Not applicable
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Comparator / control treatment
Adolescents with normal weight-control group
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Control group
Active
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Outcomes
Primary outcome [1]
338958
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Intuitive eating
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Assessment method [1]
338958
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Intuitive eating scale-2
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Timepoint [1]
338958
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once only over a 2-hour period study visit
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Secondary outcome [1]
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Mindful eating
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Assessment method [1]
438028
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Mindful eating scale
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Timepoint [1]
438028
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once only over a 2-hour period study visit
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Secondary outcome [2]
438029
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social physique anxiety
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Assessment method [2]
438029
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social physique anxiety scale
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Timepoint [2]
438029
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once only over a 2-hour period study visit
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Eligibility
Key inclusion criteria
Individuals without chronic diseases or who don't underwent any treatment that would affect their food consumption habits, ages between 10 to 19 years old.
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Minimum age
10
Years
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Maximum age
19
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
None
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Random sample
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Timing
Retrospective
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Statistical methods / analysis
When determining the sample size to be included in the study, the effect size was 0.5 (medium effect), the significance level (a) was 0.05, and the power (1-ß) was 0.90. According to these results, the sample size to be included in the study was determined to be 306. The sample in this study was expanded, and the study was conducted with 410 adolescents.
SPSS (SPSS, Chicago, IL, USA) was used for the statistical analysis. It was determined whether continuous variables had a normal distribution by using the Kolmogrov-Smirnov test. When dealing with normally distributed continuous data, the mean±sd was utilized to express the values, and the independent samples t test was employed to evaluate the statistical significance. Furthermore, in cases where the data did not exhibit a normal distribution, the data were presented as medians and the 25th–75th percentiles, and the statistical significance was evaluated using the Mann–Whitney U test. Chi-square analyses were used to compare the differences in categorical variables, which are expressed as percentages and numbers. The association between the scale scores and the state of obesity was ascertained using binary logistic regression analysis, which took age and sex into consideration. For the logistic regression analysis, before fitting the models, the values were converted to natural logarithmic values to ensure a normal distribution. 95% confidence intervals (CIs) and odds ratios (ORs) were used to assess the outcomes. P values less than 0.05 were regarded as statistically significant.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
1/01/2020
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Date of last participant enrolment
Anticipated
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Actual
1/06/2020
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Date of last data collection
Anticipated
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Actual
1/07/2020
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Sample size
Target
306
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Accrual to date
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Final
410
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Recruitment outside Australia
Country [1]
26482
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Turkey
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State/province [1]
26482
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Ankara
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Funding & Sponsors
Funding source category [1]
317074
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Self funded/Unfunded
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Name [1]
317074
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Address [1]
317074
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Country [1]
317074
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Primary sponsor type
Other
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Name
Gülsüm Sahin Bodur, Çankiri Karatekin University
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Address
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Country
Turkey
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Secondary sponsor category [1]
319767
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None
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Name [1]
319767
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Address [1]
319767
0
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Country [1]
319767
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315824
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Ankara University Clinical Research Ethics Committee
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Ethics committee address [1]
315824
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https://etikkurul.ankara.edu.tr/
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Ethics committee country [1]
315824
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Turkey
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Date submitted for ethics approval [1]
315824
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20/04/2019
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Approval date [1]
315824
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20/05/2019
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Ethics approval number [1]
315824
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12/218
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Summary
Brief summary
The researchers hypothesise there is a link between social anxiety, intuitive eating, mindful eating and anthropometric measurements of obese adolescents. Objectives: To assess the connections between social anxiety, intuitive eating, mindful eating, and anthropometric measurements of adolescents who are obese or normal weight. Methods: This study was conducted with 410 adolescents that weigh between normal and obese aged 10-19 years. Both the sociodemographic characteristics and anthropometric data were evaluated. The Intuitive Eating Scale, Mindful Eating Questionnaire and Social Physique Anxiety Scale were used. Age and sex adjustments were made before carrying out binary logistic regression analysis to determine the relationship between the scale scores and obesity status.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
135918
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Prof Alev Keser
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Address
135918
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Ankara University Department of Health Sciences, Tepebasi, Fatih street. Nu:197/A, PK:06290 Keçiören/Ankara
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Country
135918
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Turkey
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Phone
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+90 05536367348
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Fax
135918
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Email
135918
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[email protected]
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Contact person for public queries
Name
135919
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Gülsüm SAHIN BODUR
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Address
135919
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Çankiri Karatekin University Department of Health Sciences, Uluyazi Campus, B Blok, 18200 Çankiri Centre/Çankiri
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Country
135919
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Turkey
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Phone
135919
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+90 05071481458
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Fax
135919
0
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Email
135919
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[email protected]
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Contact person for scientific queries
Name
135920
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Gülsüm SAHIN BODUR
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Address
135920
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Çankiri Karatekin University Department of Health Sciences, Uluyazi Campus, B Blok, 18200 Çankiri Centre/Çankiri
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Country
135920
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Turkey
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Phone
135920
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+90 05071481458
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Fax
135920
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Email
135920
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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