Excessive Physical ExertionNCT06642064
Effects of Health Education on Physical Activity Promotion Based on PRECEDE-PROCEED Model Among Adolescents
A study testing Intervention group in people with Excessive Physical Exertion, run by Zeng Linxian at 1 site in China.
Trial summary
A randomized controlled trial (RCT) was conducted to evaluate the changes in physical activity in adolescents before and after a health education program intervention based on the PRECEDE-PROCEED model. Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Excessive Physical Exertion
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2023to 30 Dec 2023
- 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 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 15 to 18 years old, resident in Kunming, Yunnan, China;
- Adolescents who are understand the information that explained by the researcher and agree to be included in the study；
- Voluntarily participate in the experiment, cooperate with the research during the research process, and sign the informed consent；
- Adolescents who healthy to participate in physical activity (measured by PAR-Q).
Who cannot join
- Mental illness with cognitive impairment;
- People with speech or ear dysfunction;
- Recent or upcoming surgery (within 3 months), or commonalities;
- Subjects During the research period, if symptoms of discomfort occur, they are asked to stop and withdraw according to the subject\'s own will;
- Have participated in similar research in the past. People who meet any of the exclusion criteria are not included in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Anning No. 1 Middle School in KunMing,Yunnan Province, China
Kunming, Yunnan, 650500
About this study
Official title: Effects of Health Education on Physical Activity Promotion Based on PRECEDE-PROCEED Model Among Adolescents in Yunnan, China
A randomized controlled trial (RCT) was conducted to evaluate the changes in physical activity in adolescents before and after a health education program intervention based on the PRECEDE-PROCEED model.
Read the detailed description
Based on the overall theoretical framework of the PRECEDE-PROCEED model, starting from the five steps of the PRECEDE-PROCEED model, namely, sociological evaluation, epidemiological evaluation, behavioral environment evaluation, educational organization evaluation, and management policy evaluation, a cross-sectional study was conducted to understand the physical activity level, vision, physical fitness level, social support, exercise self-efficacy, perceived benefits and barriers of exercise, and school sports environment support of adolescents of different genders and grades in Yunnan Province, China, and to analyze the paths of influencing factors. Based on the PRECEDE-PROCEED model, a health education program for promoting physical activity suitable for adolescents in Yunnan Province, China was developed, and an experimental intervention was conducted using a health education program based on the PRECEDE-PROCEED model. The effect of health education based on the PRECEDE-PROCEED model on promoting physical activity among adolescents in Yunnan Province was explored, so as to achieve the improvement of adolescent physical activity level and health promotion, and it is expected to provide a reference for the promotion of physical activity and physical health of adolescents in China.
Inclusion criteria:
- 15 to 18 years old, resident in Kunming, Yunnan, China;
- Adolescents who are understand the information that explained by the researcher and agree to be included in the study；
- Voluntarily participate in the experiment, cooperate with the research during the research process, and sign the informed consent；
- Adolescents who healthy to participate in physical activity (measured by PAR-Q).
Exclusion criteria:
- Mental illness with cognitive impairment;
- People with speech or ear dysfunction;
- Recent or upcoming surgery (within 3 months), or commonalities;
- Subjects During the research period, if symptoms of discomfort occur, they are asked to stop and withdraw according to the subject's own will;
- Have participated in similar research in the past. People who meet any of the exclusion criteria are not included in the study.
- Conditions
- Excessive Physical Exertion
- Being tested
- Intervention group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
- Intervention group:
Participants were invited to participate in a 20-minute interactive learning course (PPT lecture) and a 25-minute physical activity.The intervention lasted for 12 weeks, twice a week, 45 minutes each time, for a total of 1080 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group and Control group (2 groups) | Experimental | This study held a group meeting before the formal experiment to guide all participants in advance and explain the entire experimental process to them in detail. Students with questions were given a unified and detailed explanation. Each participant received a health education manual and a physical activity record book. During the experimental stage, the researchers reminded the participants to attend the health education lectures and physical activity experiments on time. Participants were required to participate in the experiment according to the experimental content. Receives: Behavioral: Intervention group |
| control group | No intervention | Control group: Participants only received a logbook to record their physical activity every week and participated in regular physical exercise activities at school |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health education based on the PRECEDE-PROCEED model has a positive impact on promoting physical activity among adolescents in Yunnan Province
This study collected data via questionnaires, physical fitness tests, and vision assessments. Instruments included validated questionnaires-ASAFA-C, Q-SPACE-C, EBBS-CN, PAQ-CN, and S-PASESC-measuring social support, school environment, perceived benefits/barriers, activity levels, and self-efficacy. Physical tests per NSPFH 2014 included BMI, sprints, runs, jumps, pull-ups/sit-ups, and vital capacity. Data were analyzed using descriptive statistics and repeated measures ANOVA/MANOVA over four measurements.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start5 Sep 2023
- Primary completion22 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Physical ExertionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group and Control group (2 groups): • Intervention group: Participants were invited to participate in a 20-minute interactive learning course (PPT lecture) and a 25-minute physical activity.The intervention lasted for 12 weeks, twice a week, 45 minutes each time, for a total of 1080 minutes. • Control group: Participants only received a logbook to record their physical activity every week and participated in regular physical exercise activities at school.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeng Linxian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeng Linxian, Universiti Sains Malaysia
- Investigators
- Linxian Zeng, PHD, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642064
- Sponsor's protocol ID
- USM/JEPeM/22110706
- Status last verified
- Aug 2023
- First submitted
- 8 Oct 2024
- Last updated
- 15 Oct 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Health Education on Physical Activity Promotion Based on PRECEDE-PROCEED Model Among Adolescents in Yunnan, China
- ClinicalTrials.gov ID
- NCT06642064
- Acronym / sponsor ID
- USM/JEPeM/22110706
- Conditions
- Excessive Physical Exertion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Zeng LinxianUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 15 Oct 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.
A randomized controlled trial (RCT) was conducted to evaluate the changes in physical activity in adolescents before and after a health education program intervention based on the PRECEDE-PROCEED model.
Detailed description
Based on the overall theoretical framework of the PRECEDE-PROCEED model, starting from the five steps of the PRECEDE-PROCEED model, namely, sociological evaluation, epidemiological evaluation, behavioral environment evaluation, educational organization evaluation, and management policy evaluation, a cross-sectional study was conducted to understand the physical activity level, vision, physical fitness level, social support, exercise self-efficacy, perceived benefits and barriers of exercise, and school sports environment support of adolescents of different genders and grades in Yunnan Province, China, and to analyze the paths of influencing factors. Based on the PRECEDE-PROCEED model, a health education program for promoting physical activity suitable for adolescents in Yunnan Province, China was developed, and an experimental intervention was conducted using a health education program based on the PRECEDE-PROCEED model. The effect of health education based on the PRECEDE-PROCEED model on promoting physical activity among adolescents in Yunnan Province was explored, so as to achieve the improvement of adolescent physical activity level and health promotion, and it is expected to provide a reference for the promotion of physical activity and physical health of adolescents in China.
Inclusion criteria:
- 15 to 18 years old, resident in Kunming, Yunnan, China;
- Adolescents who are understand the information that explained by the researcher and agree to be included in the study；
- Voluntarily participate in the experiment, cooperate with the research during the research process, and sign the informed consent；
- Adolescents who healthy to participate in physical activity (measured by PAR-Q).
Exclusion criteria:
- Mental illness with cognitive impairment;
- People with speech or ear dysfunction;
- Recent or upcoming surgery (within 3 months), or commonalities;
- Subjects During the research period, if symptoms of discomfort occur, they are asked to stop and withdraw according to the subject's own will;
- Have participated in similar research in the past. People who meet any of the exclusion criteria are not included in the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intervention group and Control group (2 groups): • Intervention group: Participants were invited to participate in a 20-minute interactive learning course (PPT lecture) and a 25-minute physical activity.The intervention lasted for 12 weeks, twice a week, 45 minutes each time, for a total of 1080 minutes. • Control group: Participants only received a logbook to record their physical activity every week and participated in regular physical exercise activities at school.
| Arm | Type | Receives |
|---|---|---|
| Intervention group and Control group (2 groups) | Experimental | Behavioral: Intervention groupThis study held a group meeting before the formal experiment to guide all participants in advance and explain the entire experimental process to them in detail. Students with questions were given a unified and detailed explanation. Each participant received a health education manual and a physical activity record book. During the experimental stage, the researchers reminded the participants to attend the health education lectures and physical activity experiments on time. Participants were required to participate in the experiment according to the experimental content. |
| control group | No intervention | –Control group: Participants only received a logbook to record their physical activity every week and participated in regular physical exercise activities at school |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 15 to 18 years old, resident in Kunming, Yunnan, China;
- Adolescents who are understand the information that explained by the researcher and agree to be included in the study；
- Voluntarily participate in the experiment, cooperate with the research during the research process, and sign the informed consent；
- Adolescents who healthy to participate in physical activity (measured by PAR-Q).
Key exclusion criteria (5 listed)
- Mental illness with cognitive impairment;
- People with speech or ear dysfunction;
- Recent or upcoming surgery (within 3 months), or commonalities;
- Subjects During the research period, if symptoms of discomfort occur, they are asked to stop and withdraw according to the subject\'s own will;
- Have participated in similar research in the past. People who meet any of the exclusion criteria are not included 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 |
|---|---|---|
| Intervention group• Intervention group: Participants were invited to participate in a 20-minute interactive learning course (PPT lecture) and a 25-minute physical activity.The intervention lasted for 12 weeks, twice a week, 45 minutes each time, for a total of 1080 minutes. | Behavioural | Intervention group and Control group (2 groups) |
Primary outcome
Health education based on the PRECEDE-PROCEED model has a positive impact on promoting physical activity among adolescents in Yunnan Province
Time frame: 12 weeks
This study collected data via questionnaires, physical fitness tests, and vision assessments. Instruments included validated questionnaires-ASAFA-C, Q-SPACE-C, EBBS-CN, PAQ-CN, and S-PASESC-measuring social support, school environment, perceived benefits/barriers, activity levels, and self-efficacy. Physical tests per NSPFH 2014 included BMI, sprints, runs, jumps, pull-ups/sit-ups, and vital capacity. Data were analyzed using descriptive statistics and repeated measures ANOVA/MANOVA over four measurements.
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 15 Oct 2024.
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.
Linxian Zeng, PHD principal investigator
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Excessive Physical Exertion, run by Zeng Linxian 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 4 inclusion and 5 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 15 Oct 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?
Health education based on the PRECEDE-PROCEED model has a positive impact on promoting physical activity among adolescents in Yunnan Province (time frame: 12 weeks). 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 15 Oct 2024.