Physical InactivityNCT06583421
Children With High Genetic Susceptibility Benefit More From Short-term Physical Activity Interventions
A study testing 4-week MVPA intervention in people with Physical Inactivity and Obesity, Childhood, run by China Medical University, China at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Obesity, Childhood
- What is being tested?
- 4-week MVPA intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- obese children aged 10-12 years
Who cannot join
- obesity due to disease
- persons with limited physical activity
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Physical Inactivity, Obesity, Childhood
- Being tested
- 4-week MVPA intervention
- Keywords
- Obesity, Physical activity, Genetic susceptibility, Interaction
- Medical subject headings
- Sedentary Behavior, Pediatric Obesity, Obesity, Motor Activity, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-week MVPA interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the 4-week intervention
Height
eight was measured to the nearest 0.1cm using Height Measuring Ruler (Selcom, Germany).
Measured: 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)
Measured: 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).
Measured: At baseline and after 4-week of intervention
Waist circumference
Waist circumference was measured to the nearest 0.1cm with measuring tape.
Measured: At baseline and after 4-week of intervention
Hip circumference
Hip circumference was measured to the nearest 0.1cm with measuring tape.
Measured: 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.
Measured: 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.
Measured: At baseline and after 4-week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start1 Apr 2022
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haonan Zhou, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583421
- Sponsor's protocol ID
- Ethics Approval No. [2020] 075
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children With High Genetic Susceptibility Benefit More From Short-term Physical Activity Interventions
- ClinicalTrials.gov ID
- NCT06583421
- Acronym / sponsor ID
- Ethics Approval No. [2020] 075
- Conditions
- Physical Inactivity, Obesity, Childhood
- Keywords
- Obesity, Physical activity, Genetic susceptibility, Interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 4 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-week MVPA intervention group | Experimental | Behavioral: 4-week MVPA interventionThe 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. |
| 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. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- obese children aged 10-12 years
Key exclusion criteria (2 listed)
- obesity due to disease
- persons with limited physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4-week MVPA interventionThe 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. | Behavioural | 4-week MVPA intervention group |
Primary outcome
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.
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).
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)
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).
Waist circumference
Time frame: At baseline and after 4-week of intervention
Waist circumference was measured to the nearest 0.1cm with measuring tape.
Hip circumference
Time frame: At baseline and after 4-week of intervention
Hip circumference was measured to the nearest 0.1cm with measuring tape.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4-week MVPA intervention in people with Physical Inactivity and Obesity, Childhood, run by China Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity strength (time frame: During the 4-week intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.