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Body WeightNCT04907734

Differences in Skinfold Thickness Depending on the Caliper Used.

An observational study of Body Weight and Body Fat Disorder, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.

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 present study aims to compare the results obtained from the assessment of skinfolds using four anthropometric calipers (Harpenden, Holtain, Slime Guide and Lipowise). The objectives are to check if there are differences depending on the caliper used to assess skinfolds, and to study the variation in skinfold… Read more about this study

Who is it for?
Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Body Weight, Body Fat Disorder
What is being tested?
Caliper
How many people
100 participants
Where
1 siteSpain
Study dates
1 Feb 2021to 30 Apr 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 25 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: The population is conformed by students of different degrees. Finally, 102 students (46 males; 56 females) took part of the study.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Universidad Católica San Antonio

    Murcia

Other trials in Spain

About this study

The present study aims to compare the results obtained from the assessment of skinfolds using four anthropometric calipers (Harpenden, Holtain, Slime Guide and Lipowise). The objectives are to check if there are differences depending on the caliper used to assess skinfolds, and to study the variation in skinfold compressibility as a function of the time elapsed from the application of the caliper to the measurement reading, as well as the validation of the Lipowise caliper. A cross-sectional study will be carried out with a sample of 100 university students aged between 18 and 25 years. Physical activity will be assessed by means of an International Physical Activity Questionnaire (IPAQ) and hydration status by urine samples. Anthropometric assessments, including weight, height, and eight skinfolds, will be performed according to the International Society for the Advancement in Kinanthropometry protocol, using the four previously mentioned calipers. Finally, a data analysis will be carried out to compare the results of the samples taken by the calipersand to draw conclusions.

Read the 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.

Being tested
Caliper
Keywords
Fat mass, Skinfolds, Anthropometry
Medical subject headings
Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CaliperOther

    Description of the sample adipose tissue and skinfolds using different calipers.

What is being measured

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

  1. Differences in anthropometry-estimated fat mass

    Analysis of the differences between the calipers, used in the same sample and with the same formulas

    Measured: Through study completion, an average of 10 months

Secondary outcomes (1)
  1. Differences of the skinfolds sum

    Analysis of the differences between the calipers, used in the same sample and with the same formulas.

    Measured: Through study completion, an average of 10 months

Timeline

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

  1. First posted1 Jun 2021
  2. Study start1 Feb 2021
  3. Primary completion30 Apr 2021
  4. Study completion30 Apr 2021

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
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04907734
Sponsor's protocol ID
CE012109
Status last verified
May 2021
First submitted
24 May 2021
Last updated
1 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Body Weight and Body Fat Disorder, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.

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 6 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 1 Jun 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 Spain. 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?

Differences in anthropometry-estimated fat mass (time frame: Through study completion, an average of 10 months). 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 1 Jun 2021.

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