- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04907734
Differences in Skinfold Thickness Depending on the Caliper Used.
Study Overview
Detailed Description
The objectives adressed in this study are: 1- To verify whether the model of adipometer used to measure skinfolds influences the results obtained. 2- To study the variation in skinfold compressibility as a function of the time elapsed between the application of the adipometer and the measurement reading.
To achieve the above objectives, it is proposed to carry out a ten-month cross-sectional study.
Sample:
The sample will consist of 80 university students (40 males and 40 females), caucasian, aged between 18 and 25 years. This is a convenience sample recruited in Spain.
The sample size was calculated based on previous criteria defined for validation studies, i.e. the number of subjects should be 7 times the number of items to be analysed and greater than or equal to 100. Taking into account that we will assess the 8 skinfolds defined by the International Society for the Advancement in Kinanthropometry (ISAK), and taking into account possible sample losses, should be recruited 50 participants of each sex.
Informed Consent All participants will be required to complete and sign the informed consent form, prior to the day of data collection, which we will designate as day 1, in a location that ensures their privacy, but in the presence of the investigator for clarification of any doubts that may arise. Participants will be reminded that: 1) their participation is voluntary and that they may leave the study if they wish; and 2) that all data collected are confidential.
Collection procedures
All assessments will be conducted on the same day, between 8:00 am and 2:00 pm, in a laboratory with a temperature of 24ºC and ambient humidity between 65-70%, and where participant privacy is guaranteed. Data collection from each participant will last an estimated 1 hour. On the day of data collection, participants must respect the following conditions:
- No physical exercise in the 12 hours prior to the evaluation, in the case of moderate exercise, or in the last 24 hours, in the case of vigorous exercise;
- Not to have consumed products with diuretic properties in the 24 hours prior to the assessment;
- Not having used a sauna in the 24 hours prior to the assessment;
- Not having a large meal the day before or on the day of the assessment;
- In the case of female participants, be between days 8 and 21 of the menstrual cycle.
Measurements Demographic data The following demographic data: date of birth, place/country of birth, sex, ethnicity, sporting practice (modality, level, years of practice, duration and weekly frequency of training) and day of the half cycle, will be obtained through a questionnaire. This questionnaire will be completed on the day the participant signs the informed consent form (day 1).
Physical Activity The assessment of physical activity will be carried out indirectly through the application of the IPAQ questionnaire - reduced version. This questionnaire shall be completed on day 1.
Hydration status Hydration status shall be assessed indirectly, using a urine colour scale. Immediately prior to the anthropometric assessment, the participant collects a portion of urine in a suitable container provided by the research team. In the presence of the participant, the urine will be graded according to its colour, after which it is discarded by the participant.
Anthropometric measurements All anthropometric measurements will be obtained by anthropometrists with current ISAK certification, respecting the procedures described by ISAK, always using the same measuring instruments. The assessments will begin with the measurement of height and body mass, using a Seca 217 portable stadiometer and a Seca 878 scale, respectively.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Murcia, Spain
- Universidad Católica San Antonio
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- To have signed the informed consent form
- To be a student of the San Antonio Catholic University of Murcia
- To be between 18 and 25 years old
- To have a BMI between 18.5 and 24.9
- Not have any metabolic or other disease that may affect body fat
- not have received hormonal or steroid treatment in the three months prior to the evaluation, with the exception of contraceptives.
Exclusion Criteria:
- To have indicators of changes in hydration status (signs of dehydration or oedema)
- To suffer an injury that compromises compliance with the ISAK assessment protocol.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in anthropometry-estimated fat mass
Time Frame: Through study completion, an average of 10 months
|
Analysis of the differences between the calipers, used in the same sample and with the same formulas
|
Through study completion, an average of 10 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences of the skinfolds sum
Time Frame: Through study completion, an average of 10 months
|
Analysis of the differences between the calipers, used in the same sample and with the same formulas.
|
Through study completion, an average of 10 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE012109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Body Weight
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)RecruitingWeight Loss | Weight, BodyUnited States
-
Oslo University HospitalMayo Clinic; Sorlandet Hospital HF; The Hospital of Vestfold; University of TwenteActive, not recruiting
-
Fred Hutchinson Cancer CenterCompletedWeight Loss | Weight, BodyUnited States
-
Pusan National University HospitalCompletedWeight Change, Body
-
Xinhua Hospital, Shanghai Jiao Tong University...Not yet recruiting
-
Erik Ramirez LopezCompletedWeight Loss | Body CompositionMexico
-
University of TennesseeMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases...CompletedSmoking Cessation | Weight Change, BodyUnited States
-
University of LeedsDietary Assessment LtdRecruitingWeight Loss | Colorectal Surgery | Weight Change, Body | Gastroenterology SurgeryUnited Kingdom
-
Virta HealthCompleted
-
University of CopenhagenCompleted
Clinical Trials on Caliper
-
Johns Hopkins All Children's HospitalCompletedPectus ExcavatumUnited States
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityNot yet recruitingCataract ExtractionChina
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityNot yet recruiting
-
Berkeley Eye CenterCompleted
-
Cairo UniversityCompletedGeneral Anesthesia | Full Mouth Rehabilitation | Canine Overlap RelationEgypt
-
Cairo UniversityCompletedGeneral AnesthesiaEgypt
-
Christopher BellCaliper FoodsActive, not recruiting
-
Hospices Civils de LyonCompletedPediatric Intensive Care UnitFrance, Belgium, Lebanon, Switzerland