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ObesityNCT05974514

Body Awareness in Adults With Obesity

An observational study of Obesity, run by Fenerbahce University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this observational study is to examine the level of body awareness in individuals with obesity and investigate the parameters associated with body awareness. In addition, compare these parameters with healthy subjects with normal weight. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Aug 2023to 10 Sep 2023
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: The study will include 30 individuals with obesity and 30 healthy subjects. The individuals with obesity will be selected from internal medicine or dietitian clinics in Istanbul/Turkey. Healthy subjects will be age and sex-matched to serve as the control group.

Who may be able to join

  • Adults with obesity ((BMI) ≥ 30 kg/m2) aged 18-65 years, who did not receive obesity-related treatment 6 months before the study
  • Healthy adults with normal weight (BMI: 18.5-24.9 kg/m2).

Who cannot join

  • Musculoskeletal, neurological, and rheumatological disorders (fractures, sprains or strains, spine surgery, advanced respiratory or orthopaedic problems),
  • Malignancy and pregnancy within the last 12 months, which might interfere with evaluations

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Marmara University

    Maltepe

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of Physical Parameters Influencing Body Awareness in Adults With Obesity: An Observational, Controlled Study

The goal of this observational study is to examine the level of body awareness in individuals with obesity and investigate the parameters associated with body awareness. In addition, compare these parameters with healthy subjects with normal weight. The main questions it aims to answer are:

  • How is body awareness affected compared to healthy individuals?
  • Is physical activity level, dynamic balance, proprioception, and reaction time related to body awareness in individuals with obesity?
  • Is there any difference between obese and normal-weight individuals in terms of physical activity level, dynamic balance, proprioception, and reaction time?
Conditions
Obesity
Keywords
Obesity, Body awareness, Physical activity, Balance, Proprioception, Reaction time
Medical subject headings
Obesity, Motor Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Awareness

    The Body Awareness Questionnaire will be used to assess body awareness. This questionnaire includes physical, emotional, and social aspects of a person's susceptibility to normal or abnormal bodily conditions and processes, questioning susceptibility to physical reactions. There are 18 statements in the questionnaire, each scored between 1 and 7 points (1=Not at all suitable for me, 7=Completely suitable for me). The total score is 126 and higher indicates a better body awareness level.

    Measured: Baseline (Only 1 time)

Secondary outcomes (4)

  1. Physical activity level

    To evaluate self-reported physical activity level, International Physical Activity Questionnaire-Short Form (IPAQ-SF) will be used. The IPAQ-SF (7 questions) provides information about time spent on walking, moderate-intensity, and vigorous-intensity activities, as well as time spent sitting. The energy MET-minute score for these activities is calculated using standard MET values, which are as follows: Sitting: 1.5 MET, walking: 3.3 MET, moderate-intensity physical activity: 4.0 MET, vigorous-intensity physical activity: 8.0 MET.

    The total MET minutes per week are determined by taking the provided MET value and multiplying it by the total minutes spent engaging in the activity each day. Then, the MET minutes for all the days that the particular activity was performed are added up. Finally, the MET minutes from different activities are added up to get the total MET minutes per week. Physical activity level is categorized as low, moderate, and high.

    Measured: Baseline (Only 1 time)

  2. Dynamic balance

    Dynamic balance will be evaluated with the functional reach test. In this test, when standing upright, the distance covered by an extended arm during a complete forward reach, while ensuring a fixed supporting stance is measured.

    Measured: Baseline (Only 1 time)

  3. Proprioception

    The joint position sense assessment will be conducted using a Baseline bubble inclinometer to evaluate proprioception.

    Measured: Baseline (Only 1 time)

  4. Reaction time

    The Nelson Foot Reaction Test will be used to evaluate individuals' reaction speed.

    Measured: Baseline (Only 1 time)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2023
  2. Study start10 Aug 2023
  3. Primary completion8 Sep 2023
  4. Study completion10 Sep 2023

Resources

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05974514
Sponsor's protocol ID
29.12.2022/141
Status last verified
Mar 2024
First submitted
26 Jul 2023
Last updated
20 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Karaca S, Bayar B. Turkish version of body awareness questionnaire: validity and reliability study. Türk Fizyoterapi ve Rehabilitasyon Dergisi. 2021;32(1):44-50.

  • Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.

    PubMed 21058606

  • Healey EL, Allen KD, Bennell K, Bowden JL, Quicke JG, Smith R. Self-Report Measures of Physical Activity. Arthritis Care Res (Hoboken). 2020 Oct;72 Suppl 10(Suppl 10):717-730. doi: 10.1002/acr.24211. No abstract available.

    PubMed 33091242

  • Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990 Nov;45(6):M192-7. doi: 10.1093/geronj/45.6.m192.

    PubMed 2229941

  • Romero-Franco N, Montano-Munuera JA, Fernandez-Dominguez JC, Jimenez-Reyes P. Validity and Reliability of a Digital Inclinometer to Assess Knee Joint Position Sense in an Open Kinetic Chain. J Sport Rehabil. 2019 May 1;28(4):332-338. doi: 10.1123/jsr.2017-0221. Epub 2018 Dec 12.

    PubMed 29252090

  • Baert IAC, Lluch E, Struyf T, Peeters G, Van Oosterwijck S, Tuynman J, Rufai S, Struyf F. Inter- and intrarater reliability of two proprioception tests using clinical applicable measurement tools in subjects with and without knee osteoarthritis. Musculoskelet Sci Pract. 2018 Jun;35:105-109. doi: 10.1016/j.msksp.2017.11.011. Epub 2017 Nov 21.

    PubMed 29174222

  • Jung K, Kim Y, Chung Y, Hwang S. Weight-shift training improves trunk control, proprioception, and balance in patients with chronic hemiparetic stroke. Tohoku J Exp Med. 2014 Mar;232(3):195-9. doi: 10.1620/tjem.232.195.

    PubMed 24646921

  • Tamer K. Sporda fizyolojik fiziksel performansın ölçülmesi ve değerlendirilmesi. Ankara: Bağırgan Yayımevi; 2000

  • Eryildiz E, Delibas E, Kesgin IM, Ozturk IB, Ersoz Huseyinsinoglu B. Investigation of physical parameters influencing body awareness in adults with obesity: An observational, controlled study. J Bodyw Mov Ther. 2024 Oct;40:1342-1348. doi: 10.1016/j.jbmt.2024.07.037. Epub 2024 Jul 21.

    PubMed 39593455

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by Fenerbahce 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 2 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 20 Mar 2024. 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?

Body Awareness (time frame: Baseline (Only 1 time)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05974514, which also lists 9 linked publications.

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 20 Mar 2024.

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