Overweight and ObesityNCT04955769
Body Image, Self-stigma, Intuitive Eating and Exercise Behavior in Overweight and Obese
An observational study of Overweight and Obesity, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study, it was aimed to investigate the relationship between body image, self-stigma, intuitive eating and exercise attitude levels, which are thought to be effective on the mental well-being of overweight and obese individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight and Obesity
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2021to 1 Oct 2021
- 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 65 years
- All sexes
- Adult, Older adult
Study population: Overweight and obese individuals between the ages of 18-65 will be included in the study.
Who may be able to join
- Individuals aged between 18-65
- BMI ≥30 kg/m2,
- No surgical operation in the last 6 months
Who cannot join
- Musculoskeletal disorders or systemic diseases that may prevent exercise
- The presence of psychiatric or neurological disease affecting cooperation and cognitive functions
- Presence of acute pain
- Heart pain
- Presence of previous myocardial infarction, subjective heart failure, uncontrolled diabetes and hypertension
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
DiyeTat-Beslenme ve Danışmanlık
Istanbul, Kadıköy, 34714
About this study
Official title: Investigation of Body Image, Self-stigma, Intuitive Eating and Exercise Behavior in Overweight and Obese
This study, it was aimed to investigate the relationship between body image, self-stigma, intuitive eating and exercise attitude levels, which are thought to be effective on the mental well-being of overweight and obese individuals. For this purpose, the Body Image Scale, Intuitive Eating Scale-2, Exercise Stages of Change Scale-Short Form and Decisional Balance Scale in Exercise will be used to assess overweight and obese individuals. 100 people will be included in the study.
- Conditions
- Overweight and Obesity
- Keywords
- Intuitive Eating, Body Image, Self-Stigma, Exercise Behavior, Overweight and Obesity
- Medical subject headings
- Overweight, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Image Scale
It was developed by Secord and Jourand in 1953, and was adapted to Turkish society after being validated and reliable by Hovardaoğlu in 1989. The scale includes 40 items and each item is related to an organ or a part of the body (such as arm, leg, face) or a function (such as sexual activity level).
Measured: Baseline
Intuitive Eating Scale-2
The Intuitive Eating Scale-2 was developed by Tylka and Kroon Van Diest (2013) to measure intuitive eating behaviors. The scale consists of 21 questions and four sub-titles.
Measured: Baseline
Secondary outcomes (2)
Exercise Stages of Change Scale-Short Form
This 5-optioned scale evaluates the changes of exercise behavior of participants in five stages of pre contemplation, contemplation, preparation, action, and consistency. Participants have to select one of the 5 options that evaluate the intention to participate in physical activity and sports now and in the future.
Measured: Baseline
Decisional Balance Scale in Exercise
The scale is used to measure the individual decision to exercise with 10 questions designed to evaluate exercise beliefs (positive beliefs and obstacles). Participants are asked to choose on a 5-point Likert scale, in what way important every statement was with respect to their intentions to exercise, or not.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion15 Sep 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Elcin Boyacıoglu, Istanbul University - Cerrahpasa
- Investigators
- Nur Elçin Boyacıoğlu, Assist Prof, Principal investigator, Istanbul Universitesi-Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955769
- Sponsor's protocol ID
- IstanbulUC9325
- Status last verified
- Jun 2021
- First submitted
- 30 Jun 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Body Image, Self-stigma, Intuitive Eating and Exercise Behavior in Overweight and Obese
- ClinicalTrials.gov ID
- NCT04955769
- Acronym / sponsor ID
- IstanbulUC9325
- Conditions
- Overweight and Obesity
- Keywords
- Intuitive Eating, Body Image, Self-Stigma, Exercise Behavior, Overweight and Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 9 Jul 2021 (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.
This study, it was aimed to investigate the relationship between body image, self-stigma, intuitive eating and exercise attitude levels, which are thought to be effective on the mental well-being of overweight and obese individuals. For this purpose, the Body Image Scale, Intuitive Eating Scale-2, Exercise Stages of Change Scale-Short Form and Decisional Balance Scale in Exercise will be used to assess overweight and obese individuals. 100 people will be included in the study.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Overweight and obese individuals between the ages of 18-65 will be included in the study.
Key inclusion criteria (3 listed)
- Individuals aged between 18-65
- BMI ≥30 kg/m2,
- No surgical operation in the last 6 months
Key exclusion criteria (5 listed)
- Musculoskeletal disorders or systemic diseases that may prevent exercise
- The presence of psychiatric or neurological disease affecting cooperation and cognitive functions
- Presence of acute pain
- Heart pain
- Presence of previous myocardial infarction, subjective heart failure, uncontrolled diabetes and hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body Image Scale
Time frame: Baseline
It was developed by Secord and Jourand in 1953, and was adapted to Turkish society after being validated and reliable by Hovardaoğlu in 1989. The scale includes 40 items and each item is related to an organ or a part of the body (such as arm, leg, face) or a function (such as sexual activity level).
Intuitive Eating Scale-2
Time frame: Baseline
The Intuitive Eating Scale-2 was developed by Tylka and Kroon Van Diest (2013) to measure intuitive eating behaviors. The scale consists of 21 questions and four sub-titles.
2 secondary outcomes
Exercise Stages of Change Scale-Short Form
Time frame: Baseline
Decisional Balance Scale in Exercise
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
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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.
Nur Elçin Boyacıoğlu, Assist Prof principal investigator
Istanbul Universitesi-Cerrahpasa
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 Overweight and Obesity, run by Istanbul University - Cerrahpasa 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 5 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: status not confirmed, as of the sponsor's last update on 9 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nur Elçin Boyacıoğlu, Assist Prof (+905054949960, nur.boyacioglu@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Image Scale (time frame: Baseline). The study lists 2 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 9 Jul 2021.