NCT05952479

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 11, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

July 11, 2023

Last Update Submit

November 20, 2023

Conditions

Keywords

Handgrip strenghtUndernutritionNutritional status

Outcome Measures

Primary Outcomes (4)

  • 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

    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.

    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)

    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

    1 year

Study Arms (2)

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

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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)

You may not qualify if:

  • Had autoimmune disease, congenital disorders, or other chronical disease
  • Retire during the observational periods
  • Consumed steroids, antibiotics or hormone therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SDN Airlangga III

Surabaya, East Java, 60286, Indonesia

RECRUITING

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Central Study Contacts

Nur Aisiyah Widjaja, Doctor

CONTACT

Soebagijo Adi Soelistijo, Internal specialist

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator and Medical Staf in Pediatric Nutrition and Metabolic Disease

Study Record Dates

First Submitted

July 11, 2023

First Posted

July 19, 2023

Study Start

October 1, 2023

Primary Completion

July 30, 2024

Study Completion

August 31, 2024

Last Updated

November 21, 2023

Record last verified: 2023-11

Locations