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.
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.
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.
- Conditions
- Body Weight, Body Fat Disorder
- 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.
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)
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.
- First posted1 Jun 2021
- Study start1 Feb 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body WeightStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Esparza Ros, Universidad Católica San Antonio de Murcia
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Skinfold Thickness Depending on the Caliper Used.
- ClinicalTrials.gov ID
- NCT04907734
- Acronym / sponsor ID
- CE012109
- Conditions
- Body Weight, Body Fat Disorder
- Keywords
- Fat mass, Skinfolds, Anthropometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 1 Jun 2021 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The population is conformed by students of different degrees. Finally, 102 students (46 males; 56 females) took part of the study.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| CaliperDescription of the sample adipose tissue and skinfolds using different calipers. | Other | – |
Primary outcome
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
1 secondary outcome
Differences of the skinfolds sum
Time frame: Through study completion, an average of 10 months
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 1 Jun 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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.