ObesityNCT05538013
Obesity Awareness, Physical Activity Level and Sedentary Behavior in Obese Women
An observational study of Obesity, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
It is known that the incidence of obesity, which is a global health problem, is higher in women. The aim of this study is to examine the relationship of obesity awareness with physical activity level and sedentary behavior in obese women. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Survey evaluation
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2022to 15 Nov 2022
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will consist of 70 obese women volunteers aged between 18-65 years.
Who may be able to join
- The women who are ages between 18-65 years,
- BMI ≥ 30.0 kg/m2 according to WHO classification.
Who cannot join
- BMI < 30.0 kg/m2 according to WHO classification,
- Male participants,
- Inability to cooperate with assessments,
- Those who have had severe trauma or surgery that limit physical activities in the last 6 months,
- Those who have orthopedic, neurological, cardiovascular problems that limit / prevent ambulation,
- Pregnancy or suspected pregnancy,
- Individuals are included in a rehabilitation program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Relationship of Obesity Awareness With Physical Activity Level and Sedentary Behavior in Obese Women
It is known that the incidence of obesity, which is a global health problem, is higher in women. The aim of this study is to examine the relationship of obesity awareness with physical activity level and sedentary behavior in obese women.
Read the detailed description
Obese people are at risk for medical conditions that can lead to greater morbidity and mortality. It is known that the incidence of obesity, which is a global health problem, is higher in women. Lack of physical activity and sedentary behavior are well-known risk factors for obesity and the relationship between them has been supported by many studies. As a matter of fact, some studies have reported that public health programs should focus on increasing individuals' physical activity levels as well as reducing sitting time. While examining the sedentary behavior and physical activity levels of obese women, evaluating their obesity awareness status, can facilitate increasing their awareness of the disease, initiating and complying with treatment. The aim of this study is to examine the relationship of obesity awareness with physical activity level and sedentary behavior in obese women.
- Conditions
- Obesity
- Being tested
- Survey evaluation
- Keywords
- obesity, women, physical activity, sedantary
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey evaluationOther
Obesity awareness, physical activity, and sedentary time questionnaires will be applied to these cases.
| Study group | Role | What they receive |
|---|---|---|
| obese women | The study will consist of 70 obese women volunteers aged between 18-65 years. Receives: Other: Survey evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obesity Awareness
Obesity awareness will be measured by Obesity Awareness Insight Scale and Obesity.
Measured: baseline
Secondary outcomes (4)
Sedentary Behavior Questionnaire
It is a questionnaire developed to evaluate the time spent performing 9 sedentary behaviors on a normal weekday and weekend day. The questionnaire has nine different response options. For the total score, the durations of the behaviors in hours are added separately as weekdays and weekends. To obtain the average sedentary behavior times for weekdays and weekends, the total duration of the week is multiplied by 5, and the total duration of the weekend is multiplied by 2.
Measured: baseline
International Physical Activity Questionnaire Short Form
The questionnaire allows calculation of metabolic equivalent (MET) by measuring frequency, duration and physical activity intensity level in the last seven days and shows weekly physical activity amount. It is calculated as weekly working hours (MET-min/week). Physical activity levels of individuals according to the calculated MET value: (1) <600 MET-min/week not active (sedentary, inactive), (2) 600-3000 MET-min/week minimally active, and (3) >3000 MET-min/week very active (physical activity that increases well-being) classified as.
Measured: baseline
Waist circumference
Waist circumference will be measured with a tape measure in the standing position, by determining the midpoint between the lowest rib and the iliac crest from the exposed waist circumference.
Measured: baseline
Body fat-muscle ratios
These measurements will be determined by bioelectrical impedance.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start20 Sep 2022
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Biruni 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buket AKINCI, Biruni University
- Investigators
- Buket AKINCI, PT, PhD, Study chair, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538013
- Sponsor's protocol ID
- 2022/71-12
- Status last verified
- Nov 2022
- First submitted
- 9 Sep 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If the journal asks for the data, we will share it.
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship of Obesity Awareness With Physical Activity Level and Sedentary Behavior in Obese Women
- ClinicalTrials.gov ID
- NCT05538013
- Acronym / sponsor ID
- 2022/71-12
- Conditions
- Obesity
- Keywords
- obesity, women, physical activity, sedantary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 13 Sep 2022 (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.
It is known that the incidence of obesity, which is a global health problem, is higher in women. The aim of this study is to examine the relationship of obesity awareness with physical activity level and sedentary behavior in obese women.
Detailed description
Obese people are at risk for medical conditions that can lead to greater morbidity and mortality. It is known that the incidence of obesity, which is a global health problem, is higher in women. Lack of physical activity and sedentary behavior are well-known risk factors for obesity and the relationship between them has been supported by many studies. As a matter of fact, some studies have reported that public health programs should focus on increasing individuals' physical activity levels as well as reducing sitting time. While examining the sedentary behavior and physical activity levels of obese women, evaluating their obesity awareness status, can facilitate increasing their awareness of the disease, initiating and complying with treatment. The aim of this study is to examine the relationship of obesity awareness with physical activity level and sedentary behavior in obese women.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obese women | – | Other: Survey evaluationThe study will consist of 70 obese women volunteers aged between 18-65 years. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will consist of 70 obese women volunteers aged between 18-65 years.
Key inclusion criteria (2 listed)
- The women who are ages between 18-65 years,
- BMI ≥ 30.0 kg/m2 according to WHO classification.
Key exclusion criteria (7 listed)
- BMI < 30.0 kg/m2 according to WHO classification,
- Male participants,
- Inability to cooperate with assessments,
- Those who have had severe trauma or surgery that limit physical activities in the last 6 months,
- Those who have orthopedic, neurological, cardiovascular problems that limit / prevent ambulation,
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 |
|---|---|---|
| Survey evaluationObesity awareness, physical activity, and sedentary time questionnaires will be applied to these cases. | Other | obese women |
Primary outcome
Obesity Awareness
Time frame: baseline
Obesity awareness will be measured by Obesity Awareness Insight Scale and Obesity.
4 secondary outcomes
Sedentary Behavior Questionnaire
Time frame: baseline
International Physical Activity Questionnaire Short Form
Time frame: baseline
Waist circumference
Time frame: baseline
Body fat-muscle ratios
Time frame: baseline
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 16 Nov 2022.
- Individual participant dataSharing planned: Undecided. If the journal asks for the data, we will share it.
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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.
Buket AKINCI, PT, PhD study chair
Biruni University
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 Obesity, run by Biruni 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 2 inclusion and 7 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 16 Nov 2022. 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?
Obesity Awareness (time frame: baseline). 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 16 Nov 2022.