NCT06583421

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 4, 2024

Completed
Last Updated

September 4, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

August 22, 2024

Last Update Submit

August 31, 2024

Conditions

Keywords

ObesityPhysical activityGenetic susceptibilityInteraction

Outcome Measures

Primary Outcomes (8)

  • Physical activity strength

    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

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

    At baseline and after 4-week of intervention

  • Body weight

    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

    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

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

    At baseline and after 4-week of intervention

  • Hip circumference

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

    At baseline and after 4-week of intervention

  • Preperitoneal fat

    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

    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

Study Arms (2)

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.

Behavioral: 4-week MVPA intervention

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.

Interventions

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.

4-week MVPA intervention group

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • obese children aged 10-12 years

You may not qualify if:

  • obesity due to disease
  • persons with limited physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University

Shenyang, China

Location

MeSH Terms

Conditions

Sedentary BehaviorPediatric ObesityObesityMotor ActivityGenetic Predisposition to Disease

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDisease SusceptibilityDisease AttributesPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master student

Study Record Dates

First Submitted

August 22, 2024

First Posted

September 4, 2024

Study Start

April 1, 2022

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

September 4, 2024

Record last verified: 2024-08

Locations