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

August 31, 2024 updated by: Haonan Zhou, China Medical University, China

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.

Study Overview

Status

Completed

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Shenyang, China
        • China Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • obese children aged 10-12 years

Exclusion Criteria:

  • obesity due to disease
  • persons with limited physical activity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4-week MVPA intervention group
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.
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.
No Intervention: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the 4-week intervention
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).
At baseline and after 4-week of intervention
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)
At baseline and after 4-week of intervention
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).
At baseline and after 4-week of intervention
Waist circumference
Time Frame: At baseline and after 4-week of intervention
Waist circumference was measured to the nearest 0.1cm with measuring tape.
At baseline and after 4-week of intervention
Hip circumference
Time Frame: At baseline and after 4-week of intervention
Hip circumference was measured to the nearest 0.1cm with measuring tape.
At baseline and after 4-week of intervention
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.
At baseline and after 4-week of intervention
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.
At baseline and after 4-week of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

August 22, 2024

First Submitted That Met QC Criteria

August 31, 2024

First Posted (Actual)

September 4, 2024

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

August 31, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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