The Effectiveness of Intervention to Increase Physical Activity and Sleep Time of Junior High School Students

NCT07112469 | Completed DMC

• 1 other identifier: 4682/QĐ-ĐHYD
• Study Type: interventional
• Target: 948
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  From enrollment to the end of intervention at 6 months

Study Arms (2)

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.

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.

Interventions

Health promotion communication BEHAVIORAL

1. 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.

Intervention group

Guidance and practice in developing physical activity plans BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pham Ngoc Thach University of Medicine: lead

Study Sites (1)

Junior high school

Ho Chi Minh City, 70000, Vietnam

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Counseling

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

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: Vice Dean of the Faculty of Public Health

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 8, 2025
• Study Start: August 15, 2022
• Primary Completion: March 20, 2024
• Study Completion: May 30, 2024
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

VN (1)