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临床试验/NCT07054294
NCT07054294招募中不适用

Study on Total Energy Expenditure and Its Influencing Factors in Chinese Children Aged 7-13 Years (Including Rural Areas) Using the Doubly Labelled Water Method

Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
Anthropometric measurements

研究概览

简要总结

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.

详细描述

The investigators will recruit healthy Chinese children aged 7-13 years to participate in a study investigating growth and energy needs. Each participant will complete basic anthropometric measurements-including height, weight, waist and hip circumference, and mid-upper arm circumference. Questionnaires will be used to assess family socioeconomic status, dietary intake, and pubertal development. The investigators will also measure total energy expenditure, basal metabolic rate, physical activity, body composition, and environmental temperature exposure.

This research will provide accurate data on the energy expenditure of children and adolescents living in China. These data will inform national estimates of food and energy requirements, support public health nutrition strategies, and help fill critical data gaps in the IAEA Doubly Labeled Water (DLW) database.

Study Details Anthropometric Measurements

  1. Height: Height will be measured using a Seca 217 stadiometer. Participants will stand barefoot with feet approximately 60° apart. Heels, sacrum, and shoulder blades will be placed against the stadiometer's vertical rod. The head will be aligned so that the upper margin of the ear canal is level with the lower margin of the eye socket. The horizontal plate will be lowered gently to rest on the crown of the head. Two measurements will be taken and averaged; values will be recorded to the nearest 0.1 cm.
  2. Body Weight: After an overnight fast, body weight will be measured in the morning using a calibrated TANITA MC-780 scale. Participants will wear light clothing and no shoes.
  3. Waist Circumference: Waist circumference will be measured at the midpoint between the iliac crest and the lower edge of the 12th rib. Participants will stand with feet 25-30 cm apart and body weight evenly distributed. A flexible tape will be wrapped snugly (without compression), and two measurements will be averaged to the nearest 0.1 cm.
  4. Hip Circumference: Hip circumference will be measured with the participant standing straight, legs together, arms relaxed. The tape will be placed horizontally at the level of the pubic symphysis and the most prominent part of the buttocks. Two measurements will be taken and averaged.
  5. Mid-Upper Arm Circumference: The participant will stand or sit upright with the arm relaxed. The midpoint between the acromion (shoulder) and olecranon (elbow) will be marked. A measuring tape will be wrapped around this midpoint with light contact. Two measurements will be taken and averaged.

Questionnaires

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
7 Years 至 13 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy participants

排除标准

  • •Malnutrient as defined by the Chinese national standards WS/T 456-2014 and WS/T 586-2018
  • •Nutritional deficiencies
  • •Acute illness within the past 7 days
  • •Chronic diseases
  • •Cardiovascular diseases
  • •Diabetes mellitus or any form of metabolic disorders
  • •Type 1 or Type 2 diabetes
  • •Metabolic syndrome
  • •Hyperlipidemia
  • •Dyslipidemia
  • •Renal diseases
  • •Chronic kidney disease
  • •Nephrotic syndrome
  • •Musculoskeletal injuries
  • •Disabilities

结局指标

主要结局

Anthropometric measurements

时间窗: About 10 minutes.

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

Family socioeconomic status

时间窗: About 5 minutes.

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

Height

时间窗: About 3 minutes.

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

Weight

时间窗: About 5 minutes.

Weight in kilograms will be measured by TANITA.

BMI

时间窗: About 10 minutes (calculated).

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

Fat mass

时间窗: About 3 minutes.

Fat mass in kilograms will be measured by TANITA.

Fat percentage

时间窗: About 3 minutes.

Fat percentage will be measured by TANITA.

Fat-free mass

时间窗: About 3 minutes.

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

Muscle mass

时间窗: About 3 minutes.

Muscle mass in kilograms will be measured by TANITA.

Total body water

时间窗: About 3 minutes.

Total body water in kilograms will be measured by TANITA.

Secondary sexual characteristics

时间窗: About 5 minutes.

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).

Dietary intake

时间窗: About 10 minutes (three times).

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.

Basal metabolic rate

时间窗: About 30 minutes.

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

Total energy expenditure

时间窗: About 14 days.

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.

Environmental temperature

时间窗: About 14 days.

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).

Physical activity

时间窗: About 14 days.

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.

次要结局

未报告次要终点

研究者

发起方
Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xueying Zhang

Associate researcher

Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

研究点 (1)

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