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临床试验/NCT06583421
NCT06583421已完成不适用

Children With High Genetic Susceptibility Benefit More From Short-term Physical Activity Interventions

China Medical University, China1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2022年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
1
主要终点
Fat mass

研究概览

简要总结

Sharp increase in childhood obesity has been regarded as one of the most serious but preventable global public health challenges. Engaging children in moderate-to-vigorous physical activity (MVPA) is important to address the obesity problem as it is associated with a host of obesity outcomes including body weight, BMI, body fat percentage, waist circumference, lean body mass, systolic blood pressure, insulin sensitivity, cardiovascular health, and cognitive development. In China, only about one-third of children meet the recommended guidelines of at least 60 minutes of MVPA per day, and obesity rates are rising.

Children with different generic characteristics may benefit differently from MVPA, which should not be neglected when conducting interventions among children. However, most of the evidence about how genes interact with MVPA on obesity among children were addressed from cross-sectional design or synthetic lifestyle interventions. Change-on-change analysis was used in our study based on a randomized controlled trial of MVPA intervention to discusses the effect of genetics and physical activity on obesity indicators. In addition, investigators used Generic risk scores (GRSs) based on 14 BMI-associated SNPs to assess generic variation of Chinese children.

详细描述

This study is based on a randomized controlled trial of a 4-week MVPA intervention. PASS 11.0 software was used to calculate the sample size of the randomized controlled trial study (quantitative variable). Investigators recruited obese children aged 10-12 years according to the criteria for overweight and obesity in Chinese children and adolescents proposed by the Working Group on Obesity in China (WGOC). Children with physical activity-limiting diseases and obesity due to diseases were excluded.

The 4-week MVPA intervention engaged in supervised aerobic exercise, resistance training and interesting sport for 60 minutes, 3 days/week (Monday, Wednesday and Friday). No physical activity interventions were conducted in the control group. In order to safeguard the rights of the control groups, the same physical activity intervention was given to the control group at the end of the research.

Physical activity strength was measured by Tri-axial body motion recorder (ActiGraph, Wgt3x-BT, USA) to maintain relative intensity. At baseline, Physical Activity Questionnaire for Children (PAQ-C) was answered by each participant.

Height was measured to the nearest 0.1cm using Height Measuring Ruler (Selcom, Germany). Body weight and fat mass was measured to the nearest 0.1kg using Body Composition Analyzer (DC-13, Parade, Japan).Waist circumference and hip circumferencewas measured to the nearest 0.1cm with measuring tape.

Preperitoneal fat and abdominal subcutaneous fat thickness were measured by ultrasonography. The thickness and area of preperitoneal fat and abdominal subcutaneous fat were measured with a linear array probe L12-5 (38 mm, 5-12 HZ) according to the method of Suzuki.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
10 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •obese children aged 10-12 years

排除标准

  • •obesity due to disease
  • •persons with limited physical activity

研究组 & 干预措施

4-week MVPA intervention group

Experimental

The 4-week MVPA intervention engaged in supervised aerobic exercise, resistance training and interesting sport for 60 minutes, 3 days/week (Monday, Wednesday and Friday). As shown in Table S1, participants completed four sessions including preparation module (15 min), training module (30 min), and relaxation module (15 min). Another aerobic module (15 min) was added in each Friday. Children in intervention group were also encouraged to take exercise for 10 minutes together with their parents at home two hours later after dinner including ten minutes' walking (at least 1000 meters) or at least 200 times rope skipping.

干预措施: 4-week MVPA intervention (Behavioral)

Control group

No Intervention

No physical activity interventions were conducted in the control group. In order to safeguard the rights of the control groups, the same physical activity intervention was given to the control group at the end of the research.

结局指标

主要结局

Fat mass

时间窗: At baseline and after 4-week of intervention

Fat mass was measured to the nearest 0.1kg using Body Composition Analyzer (DC-13, Parade, Japan).

Physical activity strength

时间窗: During the 4-week intervention

Strength was measured by Tri-axial body motion recorder (ActiGraph, Wgt3x-BT, USA) to maintain relative intensity. Children were required to wear ActiGraph by a professional investigator on the left wrist, loosely tightened, and required to wear it at all times except for the shower during the intervention for 7 days.

Body weight

时间窗: At baseline and after 4-week of intervention

Body weight was measured to the nearest 0.1kg using Body Composition Analyzer (DC-13, Parade, Japan)

Waist circumference

时间窗: At baseline and after 4-week of intervention

Waist circumference was measured to the nearest 0.1cm with measuring tape.

Height

时间窗: At baseline and after 4-week of intervention

eight was measured to the nearest 0.1cm using Height Measuring Ruler (Selcom, Germany).

Hip circumference

时间窗: At baseline and after 4-week of intervention

Hip circumference was measured to the nearest 0.1cm with measuring tape.

Preperitoneal fat

时间窗: At baseline and after 4-week of intervention

Preperitoneal fat was measured by ultrasonography. The thickness and area of preperitoneal fat was measured with a linear array probe L12-5 (38 mm, 5-12 HZ) according to the method of Suzuki.

Abdominal subcutaneous fat thickness

时间窗: At baseline and after 4-week of intervention

Abdominal subcutaneous fat thickness was measured by ultrasonography. The thickness and area of abdominal subcutaneous fat was measured with a linear array probe L12-5 (38 mm, 5-12 HZ) according to the method of Suzuki.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Haonan Zhou

Master student

China Medical University, China

研究点 (1)

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