UndernutritionNCT05952479
The Comparison of Handgrip Strength, Lean Mass, and Blood Pressure in Primary School Children Aged 8-10 Years Old With Undernutrition and Normal Nutritional Status
An observational study of Undernutrition, run by Universitas Airlangga at 1 site in Indonesia.
Trial summary
Undernutrition occurs in 900 million individuals globally, so it is a very important health problem because it contributes to high mortality rates, especially in children. In addition, undernutrition has consequences for children's growth and development, including increased susceptibility to 1) Experiencing fat… Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Undernutrition
- How many people
- 75 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2023to 31 Aug 2024
- How long will I take part?
- 1 Year
- 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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Subjects are elementary school children aged 8-10 years with undernutrition and overnutrition. Undernutrition was determined after measuring body weight and height, then weight/age, height/age and weight/height z-scores were determined using the WHO anthroplus software. If < -2 SD, then grouped into undernutrition, but if 0 to -2 SD then grouped into normal.
Who may be able to join
- Children aged 8 years until 10 years
- Study in Primary School in Surabaya
- Healthy
- Volunteer to participate in this study (the parents sign the informed consent we sent)
Who cannot join
- Had autoimmune disease, congenital disorders, or other chronical disease
- Retire during the observational periods
- Consumed steroids, antibiotics or hormone therapy
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
SDN Airlangga III
Surabaya, East Java, 60286
About this study
Official title: Handgrip Strength, Lean Mass, and Blood Pressure in Primary School Children Aged 8-10 Years Old With Undernutrition
Undernutrition occurs in 900 million individuals globally, so it is a very important health problem because it contributes to high mortality rates, especially in children. In addition, undernutrition has consequences for children's growth and development, including increased susceptibility to 1) Experiencing fat accumulation, especially in the central part of the body; 2) Experiencing changes in body metabolism, especially fat, decreased oxidation; 3) Experiencing a decrease in resting energy expenditure and postprandial energy expenditure; 4) Insulin resistance in adulthood which results in hypertension and dyslipidemia, 5) Decreased capacity to do manual work that requires physical strength. 6) Changes occur in the function of the autonomic nervous system (Matrins et al., 2011). Loss of muscle mass and function causes muscle weakness. Handgrip strength has been used as a tool to measure muscle strength and functionality and can measure low individual mobility because handgrip strength is positively correlated with daily activity (Whiting et al., 2016). Hand grip strength or handgrip strength is used as a predictor of undernutrition in adult patients with cancer who are hospitalized (Bauer et al., 2015), and is stated as a predictor of nutritional status and changes in nutritional status (Flood et al., 2014). Other research also shows that there is a positive correlation between BMI percentile and hand grip strength (Kotecha and Desai, 2022). In studies on elderly populations, handgrip strength is positively correlated with nutritional status (Akbar and Setiati, 2018), while in populations of children at risk of malnutrition (using the Paediatric Yorkhill Malnutrition Score-PYM), it shows handgrip strength based on age (HGS z-score). and based on height is lower than children who have a lower risk of malnutrition. The HGS z-score can also be used as a predictor of fat free mass (FFM) for sick children compared to healthy children and is also related to plasma CRP (Mckirdy et al., 2021).
Based on the explanation above, this research was conducted to know the differences in hand grip strength, muscle mass, and blood pressure in undernourished children aged 8-10 years compared to normal children.
Read the detailed description
An experimental study with an analytic cross-sectional design examines muscle mass, hand grip strength, and blood pressure in children with undernutrition compared to normal. The subjects are elementary school children aged 8-10 years with undernutrition and overnutrition. Undernutrition was determined after measuring body weight and height, then weight/age, height/age, and weight/height z-scores were determined using the WHO Anthroplus software. If < -2 SD, then grouped into undernutrition, but if 0 to -2 SD then grouped into normal. Homogeneity and normality tests were carried out on the variables age, weight, height, anthropometry, arm and waist circumference, hand grip strength, muscle mass, and blood pressure. Data is presented in descriptive form (x + SD). A paired sample t-test (or Mann-Whitney test) was performed on these variables, dividing the subjects into 2: undernutrition vs. normal, with significance >0.05. Relationships between variables were analyzed using Pearson's or Spearman's correlation.
- After obtaining permission and approval from the school, the researcher conducted an initial screening by measuring height and weight, as well as the age of the prospective subject/
- Determination of nutritional status using WHO Anthroplus to determine undernourished and normal nutritional subjects
- Furthermore, the researchers reported the findings to the school for socialization and the signing of informed consent by parents
- Researchers re-measurement of weight, height, waist circumference, blood pressure and handgrip strength in subjects who are willing to take part in the study.
- Conditions
- Undernutrition
- Keywords
- Handgrip strenght, Undernutrition, Nutritional status
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Undernutrition | Undernutrition is defined as weight-for-age z-score (WAZ), height-for-age z-score (HAZ), and weight-for-height z-score (WHZ) of WHO growth chart standards < -2.00 SD | |
| Normal nutrition | Normal nutrition is defined as weight-for-age z-score (WAZ), height-for-age z-score (HAZ), and weight-for-height z-score (WHZ) of WHO growth chart standards in the range of +2 and -2.00 SD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight will be measured using Tanita RD 953-BK digital scale (presenting in mean +/- SD, in kg). The subjects were asked to step at the scale in an upright state. The body weight appears on the screen and is then noted in the data collection sheet. The subject must use light clothes without accessories or footwear
Measured: 1 year
Body height
Body height will be measured using a stadiometer Seca 213 (presenting in mean +/- SD, in cm). The subjects were asked to stand upright on the stadiometer base, with the heel, buttock, and shoulder blades touching the scale pool, their chin up, look straight ahead. The head slider was lowered until it touched the cranium. The body height was noted on the data collection sheet.
Measured: 1 year
Blood pressure
Blood pressure will be measured using Omron Automatic Blood Pressure Monitor (Omron Health Care Co., Ltd, Japan) (in mmHg), by placing the cuff on the right arm, then pulling and tightening it according to the size of the arm. After it was installed correctly (fasten and did not move), the power button on the digital tension tool was pressed, and then the microprocessor started to drive air pressure into the cuff, and then the value of blood pressure will appear in the manometer tube column. Blood pressure measurement was performed in a sitting position after the subject had rested for 10 minutes. The data will be presented as mean +/- standard deviation (SD)
Measured: 1 year
Handgrip strength
Handgrip strength will be measured using handgrip dynamometry (Camry) Patients sat comfortably on a chair and, after adjusting the handle of the dynamometer, patients were advised to hold the instrument away from the body and table. Patients were then advised to hold and compress the handle of the dynamometer with as much strength as possible with the dominant hand. Three readings were noted with a gap of more than 30 seconds. The mean of the 3 recordings was taken into consideration. Data presented as mean +/- SD, in kg
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start1 Oct 2023
- Primary completion30 Jul 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UndernutritionStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Universitas Airlangga
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Indonesia, Gadjah Mada University, Lembaga Pengelola Dana Pendidikan (Indonesia Endowment Fund for Education)
- Responsible party
- Principal investigator, Nur Aisiyah Widjaja, Universitas Airlangga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952479
- Sponsor's protocol ID
- Third ID
- Status last verified
- Nov 2023
- First submitted
- 11 Jul 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will be shared in Airlangga Repository
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Handgrip Strength, Lean Mass, and Blood Pressure in Primary School Children Aged 8-10 Years Old With Undernutrition
- ClinicalTrials.gov ID
- NCT05952479
- Acronym / sponsor ID
- Third ID
- Conditions
- Undernutrition
- Keywords
- Handgrip strenght, Undernutrition, Nutritional status
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Universitas AirlanggaUniversity, hospital or other
- Collaborators
- Universitas Indonesia, Gadjah Mada University, Lembaga Pengelola Dana Pendidikan (Indonesia Endowment Fund for Education)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 19 Jul 2023 (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.
Undernutrition occurs in 900 million individuals globally, so it is a very important health problem because it contributes to high mortality rates, especially in children. In addition, undernutrition has consequences for children's growth and development, including increased susceptibility to 1) Experiencing fat accumulation, especially in the central part of the body; 2) Experiencing changes in body metabolism, especially fat, decreased oxidation; 3) Experiencing a decrease in resting energy expenditure and postprandial energy expenditure; 4) Insulin resistance in adulthood which results in hypertension and dyslipidemia, 5) Decreased capacity to do manual work that requires physical strength. 6) Changes occur in the function of the autonomic nervous system (Matrins et al., 2011). Loss of muscle mass and function causes muscle weakness. Handgrip strength has been used as a tool to measure muscle strength and functionality and can measure low individual mobility because handgrip strength is positively correlated with daily activity (Whiting et al., 2016). Hand grip strength or handgrip strength is used as a predictor of undernutrition in adult patients with cancer who are hospitalized (Bauer et al., 2015), and is stated as a predictor of nutritional status and changes in nutritional status (Flood et al., 2014). Other research also shows that there is a positive correlation between BMI percentile and hand grip strength (Kotecha and Desai, 2022). In studies on elderly populations, handgrip strength is positively correlated with nutritional status (Akbar and Setiati, 2018), while in populations of children at risk of malnutrition (using the Paediatric Yorkhill Malnutrition Score-PYM), it shows handgrip strength based on age (HGS z-score). and based on height is lower than children who have a lower risk of malnutrition. The HGS z-score can also be used as a predictor of fat free mass (FFM) for sick children compared to healthy children and is also related to plasma CRP (Mckirdy et al., 2021).
Based on the explanation above, this research was conducted to know the differences in hand grip strength, muscle mass, and blood pressure in undernourished children aged 8-10 years compared to normal children.
Detailed description
An experimental study with an analytic cross-sectional design examines muscle mass, hand grip strength, and blood pressure in children with undernutrition compared to normal. The subjects are elementary school children aged 8-10 years with undernutrition and overnutrition. Undernutrition was determined after measuring body weight and height, then weight/age, height/age, and weight/height z-scores were determined using the WHO Anthroplus software. If < -2 SD, then grouped into undernutrition, but if 0 to -2 SD then grouped into normal. Homogeneity and normality tests were carried out on the variables age, weight, height, anthropometry, arm and waist circumference, hand grip strength, muscle mass, and blood pressure. Data is presented in descriptive form (x + SD). A paired sample t-test (or Mann-Whitney test) was performed on these variables, dividing the subjects into 2: undernutrition vs. normal, with significance >0.05. Relationships between variables were analyzed using Pearson's or Spearman's correlation.
- After obtaining permission and approval from the school, the researcher conducted an initial screening by measuring height and weight, as well as the age of the prospective subject/
- Determination of nutritional status using WHO Anthroplus to determine undernourished and normal nutritional subjects
- Furthermore, the researchers reported the findings to the school for socialization and the signing of informed consent by parents
- Researchers re-measurement of weight, height, waist circumference, blood pressure and handgrip strength in subjects who are willing to take part in the study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Undernutrition | – | –Undernutrition is defined as weight-for-age z-score (WAZ), height-for-age z-score (HAZ), and weight-for-height z-score (WHZ) of WHO growth chart standards < -2.00 SD |
| Normal nutrition | – | –Normal nutrition is defined as weight-for-age z-score (WAZ), height-for-age z-score (HAZ), and weight-for-height z-score (WHZ) of WHO growth chart standards in the range of +2 and -2.00 SD |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Subjects are elementary school children aged 8-10 years with undernutrition and overnutrition. Undernutrition was determined after measuring body weight and height, then weight/age, height/age and weight/height z-scores were determined using the WHO anthroplus software. If < -2 SD, then grouped into undernutrition, but if 0 to -2 SD then grouped into normal.
Key inclusion criteria (4 listed)
- Children aged 8 years until 10 years
- Study in Primary School in Surabaya
- Healthy
- Volunteer to participate in this study (the parents sign the informed consent we sent)
Key exclusion criteria (3 listed)
- Had autoimmune disease, congenital disorders, or other chronical disease
- Retire during the observational periods
- Consumed steroids, antibiotics or hormone therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body weight
Time frame: 1 year
Body weight will be measured using Tanita RD 953-BK digital scale (presenting in mean +/- SD, in kg). The subjects were asked to step at the scale in an upright state. The body weight appears on the screen and is then noted in the data collection sheet. The subject must use light clothes without accessories or footwear
Body height
Time frame: 1 year
Body height will be measured using a stadiometer Seca 213 (presenting in mean +/- SD, in cm). The subjects were asked to stand upright on the stadiometer base, with the heel, buttock, and shoulder blades touching the scale pool, their chin up, look straight ahead. The head slider was lowered until it touched the cranium. The body height was noted on the data collection sheet.
Blood pressure
Time frame: 1 year
Blood pressure will be measured using Omron Automatic Blood Pressure Monitor (Omron Health Care Co., Ltd, Japan) (in mmHg), by placing the cuff on the right arm, then pulling and tightening it according to the size of the arm. After it was installed correctly (fasten and did not move), the power button on the digital tension tool was pressed, and then the microprocessor started to drive air pressure into the cuff, and then the value of blood pressure will appear in the manometer tube column. Blood pressure measurement was performed in a sitting position after the subject had rested for 10 minutes. The data will be presented as mean +/- standard deviation (SD)
Handgrip strength
Time frame: 1 year
Handgrip strength will be measured using handgrip dynamometry (Camry) Patients sat comfortably on a chair and, after adjusting the handle of the dynamometer, patients were advised to hold the instrument away from the body and table. Patients were then advised to hold and compress the handle of the dynamometer with as much strength as possible with the dominant hand. Three readings were noted with a gap of more than 30 seconds. The mean of the 3 recordings was taken into consideration. Data presented as mean +/- SD, in kg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: Undecided. The data will be shared in Airlangga Repository
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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.
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 Undernutrition, run by Universitas Airlangga at 1 site in Indonesia.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Nov 2023. 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 Indonesia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nur Aisiyah Widjaja, Doctor (+628123073379, nuril08@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 1 year). The study lists 4 primary outcomes in all. 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 21 Nov 2023.