NCT05974514

Brief 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. 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

August 10, 2023

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2023

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

29 days

First QC Date

July 26, 2023

Last Update Submit

March 19, 2024

Conditions

Keywords

ObesityBody awarenessPhysical activityBalanceProprioceptionReaction time

Outcome Measures

Primary Outcomes (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.

    Baseline (Only 1 time)

Secondary Outcomes (4)

  • Physical activity level

    Baseline (Only 1 time)

  • Dynamic balance

    Baseline (Only 1 time)

  • Proprioception

    Baseline (Only 1 time)

  • Reaction time

    Baseline (Only 1 time)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Maltepe, Turkey (Türkiye)

Location

Related Publications (8)

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

    BACKGROUND
  • 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.

    PMID: 21058606BACKGROUND
  • 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.

    PMID: 33091242BACKGROUND
  • 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.

    PMID: 2229941BACKGROUND
  • 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.

    PMID: 29252090BACKGROUND
  • 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.

    PMID: 29174222BACKGROUND
  • 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.

    PMID: 24646921BACKGROUND
  • Tamer K. Sporda fizyolojik fiziksel performansın ölçülmesi ve değerlendirilmesi. Ankara: Bağırgan Yayımevi; 2000

    BACKGROUND

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, MSc Physiotherapist (PT)

Study Record Dates

First Submitted

July 26, 2023

First Posted

August 3, 2023

Study Start

August 10, 2023

Primary Completion

September 8, 2023

Study Completion

September 10, 2023

Last Updated

March 20, 2024

Record last verified: 2024-03

Locations