Moderate Physical Activity (MPA)NCT07112469
The Effectiveness of Intervention to Increase Physical Activity and Sleep Time of Junior High School Students
A study testing Health promotion communication and Guidance and practice in developing physical activity plans in people with Moderate Physical Activity (MPA) and Vigorous Physical Activity (VPA), run by Pham Ngoc Thach University of Medicine at 1 site in Vietnam.
Trial summary
The study comprises 2 phases. Phase 1: Cross-sectional study investigated the duration of moderate to vigorous physical activity (MVPA) time and the total of sleep time (TST), describing and identifying factors related to duration of MVPA time and TST. Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate Physical Activity (MPA), Vigorous Physical Activity (VPA), Moderate to Vigorous Physical Activity (MVPA)
- What is being tested?
- Health promotion communication and Guidance and practice in developing physical activity plans
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 948 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Aug 2022to 30 May 2024
- 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 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For school: All public secondary schools located in the district of Ho Chi Minh city.
- For student: Students (aged 10 - 16) attending grades 6, 7, 8, and 9 in public secondary schools located in the districts of Ho Chi Minh City.
Who cannot join
- For school: All public secondary schools located in the district of Ho Chi Minh city. do not cooperate in the research.
- For student: Students or parents of students do not agreement to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity and Sleep Time Per Day of Junior High School Students in Ho Chi Minh City and the Effectiveness of Interventions to Increase Physical Activity and Sleep Time
The study comprises 2 phases. Phase 1: Cross-sectional study investigated the duration of moderate to vigorous physical activity (MVPA) time and the total of sleep time (TST), describing and identifying factors related to duration of MVPA time and TST. Phase 2: Conduct an intervention to evaluate the effectiveness and factors related to physical activity and sleep time average day of secondary school students in Ho Chi Minh City.
Read the detailed description
Detailed of 2 phases in this study below:
Phase 1: Cross - sectional study
A cross-sectional study was conducted in 12 schools, with 2 classes selected from each school (one from grades 6-7 and one from grades 8-9). The study included a total of 948 participants with complete data for analysis (achieving the minimum sample size of 942 students). At this phase, objectives were: 1) To determine the average daily duration of MVPA and TST. 2) To investigate the association between MVPA and TST and various factors (student, family, and environmental). The sequence of activities was as follows:
- Research team contacted the school administration to send research questionnaires and informed consent forms to students and parents of the selected classes.
- On the survey day, researchers collected consent forms and instructed students to complete a self-management questionnaire about personal characteristics, family background, physical activity environment, and sleep habits. Afterwards, researchers guided consenting students in wearing Actigraph GT9X accelerometers, providing them with log sheets to record daily wear times.
- After 7 consecutive days of accelerometer wear, the research team returns to the schools to collect the devices from the school health offices. Data from the accelerometers were included in the analysis only if students have worn the device for at least four days, including at least one weekend day.
- Student physical activity and sleep data extracted using ActiLife software. The extracted parameters included: time spent in moderate-intensity physical activity (MPA), vigorous-intensity physical activity (VPA), moderate-to-vigorous physical activity (MVPA), total sleep time (TST), sleep efficiency (SE), wake after sleep onset (WASO), time in bed (TIB), and number of days with accelerometer wear.
- Following data extraction and accelerometer recalibration, the research team continues to conduct surveys at the remaining schools as planned until the target sample size is reached.
- Upon completion of data collection, data from all 12 schools is consolidated into a unified dataset. Response rates are calculated, and data cleaning is conducted. Subsequently, data analysis is performed to meet the objectives of Phase 1.
Phase 2: Interventional study
Students from classes of 8 schools in all 12 participating schools were selected from Phase 1. They were divided into intervention and control groups, each comprising 4 schools. The research team implemented intervention activities in the intervention group and evaluated the intervention's effectiveness after 1 and 6 months in both groups to compare changes. The objectives of Phase 2 included: 1) To compare changes in MVPA duration between the intervention and control groups before and after the intervention; 2) To compare changes in sleep quality between the intervention and control groups before and after the intervention. For the intervention group activities, the research team focused on counseling, health education, and guidance on developing plans to improve physical activity in students. The investigators implemented interventions in the following groups:
- Students: all students from the 4 schools and students who participated in Phase 1
- Parents
- School administrators Besides that, 4 remaining schools in the control group continued their regular academic activities without any additional interventions related to physical activity or sleep.
The researcher assessed the changes in MVPA and sleep quality between the intervention and control groups after 1 and 6 month Actigraph using.
- Conditions
- Moderate Physical Activity (MPA), Vigorous Physical Activity (VPA), Moderate to Vigorous Physical Activity (MVPA), Total of Sleep Time (TST)
- Being tested
- Health promotion communication, Guidance and practice in developing physical activity plans
- Keywords
- physical activity, sleep time, junior school students, Ho Chi Minh city, intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health promotion communicationBehavioural
- Students (Research subjects):
- All students: Students perform plays during flag-raising ceremonies for all grades. These plays emphasize the importance of increasing physical activity for better health.
- Selected students from Phase 1: Students selected in Phase 1 are guided to play games that help them identify healthy behaviors. They also receive flyers with messages about the benefits of physical activity.
- Parents: Parents receive flyers with messages about the benefits of physical activity.
- Schools:
Research team advises school principals and discusses ways to adjust factors that affect students' physical activity time. These factors are assessed based on cross-sectional study results, literature reviews, and the evaluation of the current situation at each school.
Guidance and practice in developing physical activity plansBehavioural
The intervention is exclusively implemented for students who participated in the Phase 1 survey. These students are being guided to create weekly physical activity plans by keeping a journal. They are also encouraged to self-monitor their progress. A Facebook page has been created to launch the "Active Moments with Family" challenge and provide regular health-related updates. Teachers are sharing this page with parents to promote participation in the challenge and enhance their health knowledge.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group students were selected as follows: from the 12 participating schools in Phase 1, 8 clusters (where each cluster was a school) were randomly selected. From these 8 schools, 4 were randomly assigned to the intervention group and 4 to the control group. The students selected for intervention were those who had participated in the Phase 1 survey. Receives: Behavioral: Health promotion communication; Behavioral: Guidance and practice in developing physical activity plans |
| No intervention group | No intervention | After randomly selecting a similar cluster of schools as described in the intervention group, students who had participated in the Phase 1 survey were re-surveyed one and six months after the completion of the intervention activities in the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daily MVPA and TST
Student MVPA calculations:
- Accelerometer data was collected to measure students's physical activity. This data was processed using ActiLife software to classify different intensity levels of activity. Subsequently, the time spent in MVPA was analysised. Variables extracted alongside included MPA, VPA.
- Average daily MVPA was calculated by average of weekdays (5 days) and weekend days (2 days). Unit of MVPA was minutes per day per student. The calculated results were analyzed using cluster analysis, considering the weight of each student in different clusters.
Student TST calculations:
Just as MVPA was calculated, sleep data was obtained from accelerometer readings and processed using ActiLife. TST was calculated and adjusted to reflect the full week distribution. Other variables such as TIB, WASO, and SE were also extracted from the dataset. TST is measured in hours per day per student. The calculated results are analyzed using cluster analysis, taking into account the weight.
Measured: From enrollment to the end of intervention at 6 months
Changes in MVPA and TST at 1 month and 6 months follow-ups between intervention and control groups
- After 1 month and 6 month of intervention, the study reassessed students' MVPA and TST using accelerometers and extracted similar information as described in Outcome 1. Paired t-tests were used to compare the intervention and cross-sectional phases to examine the pre-post intervention differences in the intervention group (similarly for the control group).
- The differences in MVPA and TST between the two groups were compared at 1-month and 6-month follow-ups. It was hypothesized that after 1 month, the intervention group would show an increase in MVPA and TST compared to the cross-sectional phase, while the control group would show no change compared to the baseline. After 6 months of intervention, the intervention group would still show an increase in MVPA and TST compared to the cross-sectional phase, but the increase would be less significant than the 1-month assessment, while the control group would show no change compared to the baseline.
Measured: From enrollment to the end of intervention at 6 months
Secondary outcomes (1)
Associations of MVPA and TST with factor groups derived from questionnaire responses
The variables investigated in Phase 1 through a questionnaire included:
- Individual factors: age, gender, grade level, body mass index (BMI), and self-reported physical activity participation.
- Family factors: parental occupation, parental physical activity, parental bedtime, family reminder for children's bedtime, and family encouragement for physical activity.
- Environmental factors: availability of physical activity facilities in the neighborhood and school environment, and sleep environment characteristics.
Frequency and proportion for categorical variables: school, class, subgroup, BMI subgroup, qualitative characteristics of family, qualitative characteristics of physical and sleep environments. Mean and standard deviation for normally distributed quantitative variables, and median and interquartile range for non-normally distributed quantitative variables: age, BMI, parental bedtime. Linear regression analysis within cluster analysis will be used to assess the relationshi
Measured: From enrollment to the end of intervention at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start15 Aug 2022
- Primary completion20 Mar 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Physical Activity (MPA)Studies 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
- Model description
- Cross-sectional survey study among 948 students in grades 6 to 9, from 12 secondary schools in Ho Chi Minh City to describe personal characteristics and family factors of students; exercise and sleep environment, identify factors related to MVPA time and TST. In the intervention phase, the investigators selected 8 schools from 12 schools, including 4 schools as the intervention group and 4 schools as the control group. Then, the investigators evaluated the effectiveness of the intervention by increasing MVPA time and TST after 1 month and 6 months between the two groups.
- Masking
- None (open label)
- Enrolment
- 948 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pham Ngoc Thach University of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Tang, Pham Ngoc Thach University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112469
- Sponsor's protocol ID
- 4682/QĐ-ĐHYD
- Status last verified
- Aug 2025
- First submitted
- 16 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Sleep Time Per Day of Junior High School Students in Ho Chi Minh City and the Effectiveness of Interventions to Increase Physical Activity and Sleep Time
- ClinicalTrials.gov ID
- NCT07112469
- Acronym / sponsor ID
- 4682/QĐ-ĐHYD
- Conditions
- Moderate Physical Activity (MPA), Vigorous Physical Activity (VPA), Moderate to Vigorous Physical Activity (MVPA), Total of Sleep Time (TST)
- Keywords
- physical activity, sleep time, junior school students, Ho Chi Minh city, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 948 participants (actual)
- Lead sponsor
- Pham Ngoc Thach University of MedicineUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 8 Aug 2025 (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.
The study comprises 2 phases. Phase 1: Cross-sectional study investigated the duration of moderate to vigorous physical activity (MVPA) time and the total of sleep time (TST), describing and identifying factors related to duration of MVPA time and TST. Phase 2: Conduct an intervention to evaluate the effectiveness and factors related to physical activity and sleep time average day of secondary school students in Ho Chi Minh City.
Detailed description
Detailed of 2 phases in this study below:
Phase 1: Cross - sectional study
A cross-sectional study was conducted in 12 schools, with 2 classes selected from each school (one from grades 6-7 and one from grades 8-9). The study included a total of 948 participants with complete data for analysis (achieving the minimum sample size of 942 students). At this phase, objectives were: 1) To determine the average daily duration of MVPA and TST. 2) To investigate the association between MVPA and TST and various factors (student, family, and environmental). The sequence of activities was as follows:
- Research team contacted the school administration to send research questionnaires and informed consent forms to students and parents of the selected classes.
- On the survey day, researchers collected consent forms and instructed students to complete a self-management questionnaire about personal characteristics, family background, physical activity environment, and sleep habits. Afterwards, researchers guided consenting students in wearing Actigraph GT9X accelerometers, providing them with log sheets to record daily wear times.
- After 7 consecutive days of accelerometer wear, the research team returns to the schools to collect the devices from the school health offices. Data from the accelerometers were included in the analysis only if students have worn the device for at least four days, including at least one weekend day.
- Student physical activity and sleep data extracted using ActiLife software. The extracted parameters included: time spent in moderate-intensity physical activity (MPA), vigorous-intensity physical activity (VPA), moderate-to-vigorous physical activity (MVPA), total sleep time (TST), sleep efficiency (SE), wake after sleep onset (WASO), time in bed (TIB), and number of days with accelerometer wear.
- Following data extraction and accelerometer recalibration, the research team continues to conduct surveys at the remaining schools as planned until the target sample size is reached.
- Upon completion of data collection, data from all 12 schools is consolidated into a unified dataset. Response rates are calculated, and data cleaning is conducted. Subsequently, data analysis is performed to meet the objectives of Phase 1.
Phase 2: Interventional study
Students from classes of 8 schools in all 12 participating schools were selected from Phase 1. They were divided into intervention and control groups, each comprising 4 schools. The research team implemented intervention activities in the intervention group and evaluated the intervention's effectiveness after 1 and 6 months in both groups to compare changes. The objectives of Phase 2 included: 1) To compare changes in MVPA duration between the intervention and control groups before and after the intervention; 2) To compare changes in sleep quality between the intervention and control groups before and after the intervention. For the intervention group activities, the research team focused on counseling, health education, and guidance on developing plans to improve physical activity in students. The investigators implemented interventions in the following groups:
- Students: all students from the 4 schools and students who participated in Phase 1
- Parents
- School administrators Besides that, 4 remaining schools in the control group continued their regular academic activities without any additional interventions related to physical activity or sleep.
The researcher assessed the changes in MVPA and sleep quality between the intervention and control groups after 1 and 6 month Actigraph using.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross-sectional survey study among 948 students in grades 6 to 9, from 12 secondary schools in Ho Chi Minh City to describe personal characteristics and family factors of students; exercise and sleep environment, identify factors related to MVPA time and TST. In the intervention phase, the investigators selected 8 schools from 12 schools, including 4 schools as the intervention group and 4 schools as the control group. Then, the investigators evaluated the effectiveness of the intervention by increasing MVPA time and TST after 1 month and 6 months between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Health promotion communication, Behavioral: Guidance and practice in developing physical activity plansThe intervention group students were selected as follows: from the 12 participating schools in Phase 1, 8 clusters (where each cluster was a school) were randomly selected. From these 8 schools, 4 were randomly assigned to the intervention group and 4 to the control group. The students selected for intervention were those who had participated in the Phase 1 survey. |
| No intervention group | No intervention | –After randomly selecting a similar cluster of schools as described in the intervention group, students who had participated in the Phase 1 survey were re-surveyed one and six months after the completion of the intervention activities in the intervention group. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- For school: All public secondary schools located in the district of Ho Chi Minh city.
- For student: Students (aged 10 - 16) attending grades 6, 7, 8, and 9 in public secondary schools located in the districts of Ho Chi Minh City.
Key exclusion criteria (2 listed)
- For school: All public secondary schools located in the district of Ho Chi Minh city. do not cooperate in the research.
- For student: Students or parents of students do not agreement to participate in the study.
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 |
|---|---|---|
| Health promotion communication1. Students (Research subjects): * All students: Students perform plays during flag-raising ceremonies for all grades. These plays emphasize the importance of increasing physical activity for better health. * Selected students from Phase 1: Students selected in Phase 1 are guided to play games that help them identify healthy behaviors. They also receive flyers with messages about the benefits of physical activity. 2. Parents: Parents receive flyers with messages about the benefits of physical activity. 3. Schools: Research team advises school principals and discusses ways to adjust factors that affect students' physical activity time. These factors are assessed based on cross-sectional study results, literature reviews, and the evaluation of the current situation at each school. | Behavioural | Intervention group |
| Guidance and practice in developing physical activity plansThe intervention is exclusively implemented for students who participated in the Phase 1 survey. These students are being guided to create weekly physical activity plans by keeping a journal. They are also encouraged to self-monitor their progress. A Facebook page has been created to launch the "Active Moments with Family" challenge and provide regular health-related updates. Teachers are sharing this page with parents to promote participation in the challenge and enhance their health knowledge. | Behavioural | Intervention group |
Primary outcome
Average Daily MVPA and TST
Time frame: From enrollment to the end of intervention at 6 months
Student MVPA calculations: * Accelerometer data was collected to measure students's physical activity. This data was processed using ActiLife software to classify different intensity levels of activity. Subsequently, the time spent in MVPA was analysised. Variables extracted alongside included MPA, VPA. * Average daily MVPA was calculated by average of weekdays (5 days) and weekend days (2 days). Unit of MVPA was minutes per day per student. The calculated results were analyzed using cluster analysis, considering the weight of each student in different clusters. Student TST calculations: Just as MVPA was calculated, sleep data was obtained from accelerometer readings and processed using ActiLife. TST was calculated and adjusted to reflect the full week distribution. Other variables such as TIB, WASO, and SE were also extracted from the dataset. TST is measured in hours per day per student. The calculated results are analyzed using cluster analysis, taking into account the weight.
Changes in MVPA and TST at 1 month and 6 months follow-ups between intervention and control groups
Time frame: From enrollment to the end of intervention at 6 months
* After 1 month and 6 month of intervention, the study reassessed students' MVPA and TST using accelerometers and extracted similar information as described in Outcome 1. Paired t-tests were used to compare the intervention and cross-sectional phases to examine the pre-post intervention differences in the intervention group (similarly for the control group). * The differences in MVPA and TST between the two groups were compared at 1-month and 6-month follow-ups. It was hypothesized that after 1 month, the intervention group would show an increase in MVPA and TST compared to the cross-sectional phase, while the control group would show no change compared to the baseline. After 6 months of intervention, the intervention group would still show an increase in MVPA and TST compared to the cross-sectional phase, but the increase would be less significant than the 1-month assessment, while the control group would show no change compared to the baseline.
1 secondary outcome
Associations of MVPA and TST with factor groups derived from questionnaire responses
Time frame: From enrollment to the end of intervention at 6 months
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 8 Aug 2025.
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 Health promotion communication and Guidance and practice in developing physical activity plans in people with Moderate Physical Activity (MPA) and Vigorous Physical Activity (VPA), run by Pham Ngoc Thach University of Medicine at 1 site in Vietnam.
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 2 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 8 Aug 2025. 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 Vietnam. 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?
Average Daily MVPA and TST (time frame: From enrollment to the end of intervention at 6 months). The study lists 2 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 8 Aug 2025.