Trial Review

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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
Scientific title
The Relationships between Intuitive Eating, Mindful Eating, Social Physique Anxiety and Obesity in Adolescents
Secondary ID [1] 312641 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 334607 0
social physique anxiety 334827 0
Condition category
Condition code
Diet and Nutrition 331192 331192 0 0
Obesity
Diet and Nutrition 331193 331193 0 0
Other diet and nutrition disorders
Mental Health 331385 331385 0 0
Anxiety

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 329160 0
Not applicable
Comparator / control treatment
Adolescents with normal weight-control group
Control group
Active

Outcomes
Primary outcome [1] 338958 0
Intuitive eating
Timepoint [1] 338958 0
once only over a 2-hour period study visit
Secondary outcome [1] 438028 0
Mindful eating
Timepoint [1] 438028 0
once only over a 2-hour period study visit
Secondary outcome [2] 438029 0
social physique anxiety
Timepoint [2] 438029 0
once only over a 2-hour period study visit

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.
Minimum age
10 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Retrospective
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2020
Date of last participant enrolment
Anticipated
Actual
1/06/2020
Date of last data collection
Anticipated
Actual
1/07/2020
Sample size
Target
306
Accrual to date
Final
410
Recruitment outside Australia
Country [1] 26482 0
Turkey
State/province [1] 26482 0
Ankara

Funding & Sponsors
Funding source category [1] 317074 0
Self funded/Unfunded
Name [1] 317074 0
Country [1] 317074 0
Primary sponsor type
Other
Name
Gülsüm Sahin Bodur, Çankiri Karatekin University
Address
Country
Turkey
Secondary sponsor category [1] 319767 0
None
Name [1] 319767 0
Address [1] 319767 0
Country [1] 319767 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315824 0
Ankara University Clinical Research Ethics Committee
Ethics committee address [1] 315824 0
Ethics committee country [1] 315824 0
Turkey
Date submitted for ethics approval [1] 315824 0
20/04/2019
Approval date [1] 315824 0
20/05/2019
Ethics approval number [1] 315824 0
12/218

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135918 0
Prof Alev Keser
Address 135918 0
Ankara University Department of Health Sciences, Tepebasi, Fatih street. Nu:197/A, PK:06290 Keçiören/Ankara
Country 135918 0
Turkey
Phone 135918 0
+90 05536367348
Fax 135918 0
Email 135918 0
akeser@ankara.edu.tr
Contact person for public queries
Name 135919 0
Gülsüm SAHIN BODUR
Address 135919 0
Çankiri Karatekin University Department of Health Sciences, Uluyazi Campus, B Blok, 18200 Çankiri Centre/Çankiri
Country 135919 0
Turkey
Phone 135919 0
+90 05071481458
Fax 135919 0
Email 135919 0
gulsumsahinbodur@karatekin.edu.tr
Contact person for scientific queries
Name 135920 0
Gülsüm SAHIN BODUR
Address 135920 0
Çankiri Karatekin University Department of Health Sciences, Uluyazi Campus, B Blok, 18200 Çankiri Centre/Çankiri
Country 135920 0
Turkey
Phone 135920 0
+90 05071481458
Fax 135920 0
Email 135920 0
gulsumsahinbodur@karatekin.edu.tr

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.