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NCT Number: NCT06583421

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

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.

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Key information

Conditions

Physical Inactivity Behavior Body Weight Disease Attributes Disease Susceptibility Genetic Predisposition to Disease Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Childhood Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Obesity Sedentary Behavior Signs and Symptoms

Age range

10 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University

Shenyang, China

About this study

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.

The whole genomic DNA of blood mononuclear cells was performed using a fully automated nucleic acid extractor (QIAGEN, QIAcube, Germany), the DNA extraction reagents were used in a magnetic bead method DNA extraction kit (QIAGEN, 51331, Germany), and the detailed steps were performed according to the reagent and instrument instructions. 14 SNP loci associated with obesity and BMI were reliably validated based on GWAS studies in large Asian populations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • obese children aged 10-12 years

Exclusion criteria

  • obesity due to disease
  • persons with limited physical activity

Treatment and study plan

4-week MVPA intervention

Behavioral

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.

Primary outcomes

  1. Physical activity strength

    Time frame: 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.

  2. Height

    Time frame: At baseline and after 4-week of intervention

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

  3. Body weight

    Time frame: 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)

  4. Fat mass

    Time frame: 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).

  5. Waist circumference

    Time frame: At baseline and after 4-week of intervention

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

  6. Hip circumference

    Time frame: At baseline and after 4-week of intervention

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

  7. Preperitoneal fat

    Time frame: 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.

  8. Abdominal subcutaneous fat thickness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

China Medical University, China

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 4, 2024
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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