NCT07054294

Brief Summary

By 2050, there will be 9 billion people on earth. It will be necessary to feed them to avoid the population catastrophe predicted by Malthus 150 years ago. Yet a major issue facing governments is that the current method by which food demands are estimated is widely acknowledged as completely inaccurate. An accurate method is available. It is based on measurements of isotope elimination, called the doubly labelled water (DLW) method. In 2018, the International Atomic Energy Agency (IAEA) hosted and compiled a database of measurements using this technique. It showed that the use of the DLW method has been mostly restricted to the USA and Western Europe. It has rarely been applied across Africa and Asia. The database also focused on adults, leaving much unknown about the energy balance in children and adolescents. There is a clear need to fill this gap in knowledge, providing information that governments across Low- and Middle-Income countries can use to forecast future food demands. In China, the prevalence of overweight and obesity among children and adolescents is increasing. In 2009, 22.1% of Chinese youth aged 7-17 years were either overweight or obese, according to the China Health and Nutrition Survey. The obesity rate has increased fourfold since 1995. One of the most concerning problems is the persistence of childhood obesity into adulthood. The causes of this obesity epidemic are strongly disputed, with some suggesting it is due to increasingly sedentary lifestyles (computers, cars, phones, etc.), while others suggest it is mostly due to changing food patterns (junk food and sugar-sweetened beverages). Measuring energy expenditure in children and adolescents in China will address whether declining expenditure due to reduced physical activity is a key cause of the epidemic. Most measurements come from urban populations, leaving rural populations greatly underrepresented.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
20mo left

Started Sep 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress28%
Sep 2025Dec 2027

First Submitted

Initial submission to the registry

June 17, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

July 8, 2025

Status Verified

June 1, 2025

Enrollment Period

2.3 years

First QC Date

June 17, 2025

Last Update Submit

July 7, 2025

Conditions

Outcome Measures

Primary Outcomes (18)

  • Height

    Height in centimetres will be measured by Leicester stadiometer(Seca 217, Germany).

    About 3 minutes.

  • Weight

    Weight in kilograms will be measured by TANITA.

    About 5 minutes.

  • BMI

    BMI values in kg/m2 were calculated from weight measured by TANITA and height measured by Leicester stadiometer (Seca 217, Germany).

    About 10 minutes (calculated).

  • Fat mass

    Fat mass in kilograms will be measured by TANITA.

    About 3 minutes.

  • Fat percentage

    Fat percentage will be measured by TANITA.

    About 3 minutes.

  • Fat-free mass

    Fat-free mass in kilograms will be measured by TANITA.

    About 3 minutes.

  • Muscle mass

    Muscle mass in kilograms will be measured by TANITA.

    About 3 minutes.

  • Total body water

    Total body water in kilograms will be measured by TANITA.

    About 3 minutes.

  • Anthropometric measurements

    Anthropometric measurements, including waist circumference (measured in centimeters), will be obtained using a flexible tape measure following standardized protocols.

    About 10 minutes.

  • Anthropometric measurements

    Anthropometric measurements, including hip circumference (measured in centimeters), will be obtained using a flexible tape measure following standardized protocols.

    About 10 minutes.

  • Anthropometric measurements

    Anthropometric measurements, including mid-upper arm circumference (measured in centimeters), will be obtained using a flexible tape measure following standardized protocols.

    About 10 minutes.

  • Family socioeconomic status

    Family socioeconomic status will be assessed by the Family Socioeconomic Status Questionnaire (SES).

    About 5 minutes.

  • Secondary sexual characteristics

    The Tanner stages are used to assess the development of secondary sexual characteristics and are divided into five stages. For boys, the evaluation includes pubic hair development and genital development (including testicular and penile growth). For girls, the evaluation includes pubic hair development and breast development (thelarche).

    About 5 minutes.

  • Dietary intake

    The 24-hour dietary recall questionnaire is used to investigate the dietray intake level of the subjects. Three daily meals will be collected to calculate the dietary intake in kcal or MJ.

    About 10 minutes (three times).

  • Basal metabolic rate

    The basal metabolic rate in kcal or MJ will be measured by respiratory indirect calorimetry (Cosmed).

    About 30 minutes.

  • Total energy expenditure

    Total energy expenditure in kcal or MJ will be measured using the DLW method. TEE will then be calculated using mean CO2 production using the Weir equation.

    About 14 days.

  • Environmental temperature

    The iButton (DS1921G) monitors will be provided for the assessment of both indoor and outdoor temperature of their living environment, measured in degrees Celsius (°C).

    About 14 days.

  • Physical activity

    Physical activity of the participants will be recorded using a GT3X accelerometer worn at the waist for a consecutive period of 14 days. Outcomes measured by the GT3X included physical activity energy expenditure in kcal or MJ, Total MVPA in minutes per day , and Vector Magnitude Counts expressed as counts per minute.

    About 14 days.

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of healthy children aged 7 to 13 years who exhibit normal growth and development. Participants will neither be overweight nor obese, nor will they have any nutritional deficiencies. They will be capable of cooperating to complete all required measurements. None of the children will have been diagnosed with chronic diseases or musculoskeletal injuries or disabilities. Additionally, all participants will be free from acute clinical illnesses for at least seven days prior to the study.

You may qualify if:

  • Healthy participants

You may not qualify if:

  • Malnutrient as defined by the Chinese national standards WS/T 456-2014 and WS/T 586-2018
  • Nutritional deficiencies
  • Overweight
  • Obesity
  • Acute illness within the past 7 days
  • Fever
  • Diarrhea
  • Vomiting
  • Chronic diseases
  • Cardiovascular diseases
  • Diabetes mellitus or any form of metabolic disorders
  • Type 1 or Type 2 diabetes
  • Metabolic syndrome
  • Hyperlipidemia
  • Dyslipidemia
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Institutes of Advanced Technology,Chinese Academy of Sciences

Shenzhen, Guangdonng, 518055, China

RECRUITING

Related Publications (2)

  • Speakman JR, Yamada Y, Sagayama H, Berman ESF, Ainslie PN, Andersen LF, Anderson LJ, Arab L, Baddou I, Bedu-Addo K, Blaak EE, Blanc S, Bonomi AG, Bouten CVC, Bovet P, Buchowski MS, Butte NF, Camps SGJA, Close GL, Cooper JA, Creasy SA, Das SK, Cooper R, Dugas LR, Ebbeling CB, Ekelund U, Entringer S, Forrester T, Fudge BW, Goris AH, Gurven M, Hambly C, El Hamdouchi A, Hoos MB, Hu S, Joonas N, Joosen AM, Katzmarzyk P, Kempen KP, Kimura M, Kraus WE, Kushner RF, Lambert EV, Leonard WR, Lessan N, Ludwig DS, Martin CK, Medin AC, Meijer EP, Morehen JC, Morton JP, Neuhouser ML, Nicklas TA, Ojiambo RM, Pietilainen KH, Pitsiladis YP, Plange-Rhule J, Plasqui G, Prentice RL, Rabinovich RA, Racette SB, Raichlen DA, Ravussin E, Reynolds RM, Roberts SB, Schuit AJ, Sjodin AM, Stice E, Urlacher SS, Valenti G, Van Etten LM, Van Mil EA, Wells JCK, Wilson G, Wood BM, Yanovski J, Yoshida T, Zhang X, Murphy-Alford AJ, Loechl CU, Melanson EL, Luke AH, Pontzer H, Rood J, Schoeller DA, Westerterp KR, Wong WW; IAEA DLW database group. A standard calculation methodology for human doubly labeled water studies. Cell Rep Med. 2021 Feb 16;2(2):100203. doi: 10.1016/j.xcrm.2021.100203. eCollection 2021 Feb 16.

    PMID: 33665639BACKGROUND
  • WEIR JB. New methods for calculating metabolic rate with special reference to protein metabolism. J Physiol. 1949 Aug;109(1-2):1-9. doi: 10.1113/jphysiol.1949.sp004363. No abstract available.

    PMID: 15394301BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples will be collected from children over a 14-day period following the administration of doubly labeled water (DLW). The analysis of oxygen-18 and deuterium in these urine samples will be used to calculate the total energy expenditure of the children.

Central Study Contacts

Xueying Zhang, Doctor

CONTACT

Xinyue Ma, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate researcher

Study Record Dates

First Submitted

June 17, 2025

First Posted

July 8, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

July 8, 2025

Record last verified: 2025-06

Locations