Physical InactivityNCT06140680
Intervention in Habit, Automatic Affective Evaluations and Physical Activity Among University Students
A study testing LifelongU and Physical education in people with Physical Inactivity and Sedentary Behavior, run by Universiti Sains Malaysia at 1 site in China.
Trial summary
The goal of this clinical trial is to test the effectiveness of the LifelongU intervention in habit, automatic affective evaluation and physical activity among university students. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Sedentary Behavior
- What is being tested?
- LifelongU and Physical education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 12 Feb 2024to 14 Jun 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 18-25 years
- failure meeting the recommended physical activity guidelines (< 150 minutes MVPA or < 70 minutes VIPA in total a week) at the time of recruitment, screened via the Global Physical Activity Questionnaire
Who cannot join
- student athletes
- the presence of health conditions that prevented safe engagement in physical activity, screened via the PAR-Q+.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dandan Huang
Chongqing, Chongqing Municipality, 400044
DANDAN HUANG, +8613996265158, dandanh@student.usm.my
About this study
Official title: The Effectiveness of the LifelongU Intervention in Habit, Automatic Affective Evaluations and Physical Activity Among University Students With Physical Inactivity
The goal of this clinical trial is to test the effectiveness of the LifelongU intervention in habit, automatic affective evaluation and physical activity among university students. The main questions aim to answer are:
- What is the difference in habit, automatic affective evaluation and physical activity between the intervention and control groups?
- What is the difference in habit, automatic affective evaluation and physical activity between the before and after intervention?
Read more
Participants will attend 12 sessions of four modules that performed face-to-face physical education lessons. Lesson content included 10-min health-related fitness knowledge, 30-min fitness test and training, 50-min motor skill training with behavior change techniques (90 min per a lesson, once a week).
Researchers will compare control group to see if any effect difference.
Read the detailed description
A range of behavior change techniques derived from habit formation and self-regulation domain strategies will be used. These include behavioral rehearsal/practice, prompts/cues, and self-monitoring. The overall aim was to help students increase perceptions of physical competence and confidence, build positive affective attitude of physical activity, and develop autonomous association between physical activity and cues of time or events. Moreover, this intervention used student-centered learning strategies, game-centered approach in terms of mode of learning, and flexible in choice of timing, frequency, duration, and intensity of physical activity.
- Conditions
- Physical Inactivity, Sedentary Behavior
- Being tested
- LifelongU, Physical education
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifelongUBehavioural
The LifelongU intervention is an abbreviation name from LifelongU: Cultivating Physical Literacy for University \& Beyond. "LifelongU" is a unique and coined term that symbolizes the program's commitment to promoting physical literacy as a lifelong journey. It combines the words "Lifelong" and "University" to represent an intervention that focuses on physical literacy development not only during the university years but also throughout a person's entire life. The name is designed to convey the idea that physical literacy is an asset that will benefit individuals in all aspects of life, even after they leave the university.
Physical educationBehavioural
The control group received 12-week traditional physical education lesson as usual.
| Study group | Role | What they receive |
|---|---|---|
| LifelongU | Experimental | Four modules that performed face-to-face physical education lessons:
1. health-related fitness knowledge
2. fitness test and training
3. motor skill training
4. behavior change techniques (habit formation and implementation intention) Receives: Behavioral: LifelongU |
| Physical education | Active comparator | Classic physical education lessons: physical fitness training and skill training Receives: Behavioral: Physical education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
Using [Global Physical Activity Questionnaire]: the minimum time are 0 minutes per a day and maximum time are 1440 minutes per a day, and higher scores mean a better physical activity level.
Measured: Assessments will be conducted at baseline (after the screening), 6th week after the baseline, 12th week, and 16th week.
Habit
Using questionnaire [Physical activity self-report habit index]: This is a 12-item questionnaire answered on a 7-point Likert scale ranging from 1 (Strongly disagree) to 7 (Strongly agree), with higher scores indicating stronger habit strength.
Measured: Assessments will be conducted at baseline (after the screening), 6th week after the baseline, 12th week, and 16th week.
Association Affective Evaluation
Using [Single-Category Implicit Association Test]: the minimum value is 0 and maximum values is 5, and higher scores mean a positive affective attitude.
Measured: Assessments will be conducted at baseline (after the screening), 6th week after the baseline, 12th week, and 16th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start12 Feb 2024 (estimated)
- Primary completion17 May 2024 (estimated)
- Study completion14 Jun 2024 (estimated)
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dandan Huang, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140680
- Sponsor's protocol ID
- DANDAN HUANG
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 20 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the LifelongU Intervention in Habit, Automatic Affective Evaluations and Physical Activity Among University Students With Physical Inactivity
- ClinicalTrials.gov ID
- NCT06140680
- Acronym / sponsor ID
- DANDAN HUANG
- Conditions
- Physical Inactivity, Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 12 Feb 2024 (estimated)
- Primary completion
- 17 May 2024 (estimated)
- Study completion
- 14 Jun 2024 (estimated)
- First posted
- 20 Nov 2023 (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 goal of this clinical trial is to test the effectiveness of the LifelongU intervention in habit, automatic affective evaluation and physical activity among university students. The main questions aim to answer are:
- What is the difference in habit, automatic affective evaluation and physical activity between the intervention and control groups?
- What is the difference in habit, automatic affective evaluation and physical activity between the before and after intervention?
Participants will attend 12 sessions of four modules that performed face-to-face physical education lessons. Lesson content included 10-min health-related fitness knowledge, 30-min fitness test and training, 50-min motor skill training with behavior change techniques (90 min per a lesson, once a week).
Researchers will compare control group to see if any effect difference.
Detailed description
A range of behavior change techniques derived from habit formation and self-regulation domain strategies will be used. These include behavioral rehearsal/practice, prompts/cues, and self-monitoring. The overall aim was to help students increase perceptions of physical competence and confidence, build positive affective attitude of physical activity, and develop autonomous association between physical activity and cues of time or events. Moreover, this intervention used student-centered learning strategies, game-centered approach in terms of mode of learning, and flexible in choice of timing, frequency, duration, and intensity of physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LifelongU | Experimental | Behavioral: LifelongUFour modules that performed face-to-face physical education lessons: 1. health-related fitness knowledge 2. fitness test and training 3. motor skill training 4. behavior change techniques (habit formation and implementation intention) |
| Physical education | Active comparator | Behavioral: Physical educationClassic physical education lessons: physical fitness training and skill training |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- aged 18-25 years
- failure meeting the recommended physical activity guidelines (< 150 minutes MVPA or < 70 minutes VIPA in total a week) at the time of recruitment, screened via the Global Physical Activity Questionnaire
Key exclusion criteria (2 listed)
- student athletes
- the presence of health conditions that prevented safe engagement in physical activity, screened via the PAR-Q+.
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 |
|---|---|---|
| LifelongUThe LifelongU intervention is an abbreviation name from LifelongU: Cultivating Physical Literacy for University \& Beyond. "LifelongU" is a unique and coined term that symbolizes the program's commitment to promoting physical literacy as a lifelong journey. It combines the words "Lifelong" and "University" to represent an intervention that focuses on physical literacy development not only during the university years but also throughout a person's entire life. The name is designed to convey the idea that physical literacy is an asset that will benefit individuals in all aspects of life, even after they leave the university. | Behavioural | LifelongU |
| Physical educationThe control group received 12-week traditional physical education lesson as usual. | Behavioural | Physical education |
Primary outcome
Physical Activity
Time frame: Assessments will be conducted at baseline (after the screening), 6th week after the baseline, 12th week, and 16th week.
Using [Global Physical Activity Questionnaire]: the minimum time are 0 minutes per a day and maximum time are 1440 minutes per a day, and higher scores mean a better physical activity level.
Habit
Time frame: Assessments will be conducted at baseline (after the screening), 6th week after the baseline, 12th week, and 16th week.
Using questionnaire [Physical activity self-report habit index]: This is a 12-item questionnaire answered on a 7-point Likert scale ranging from 1 (Strongly disagree) to 7 (Strongly agree), with higher scores indicating stronger habit strength.
Association Affective Evaluation
Time frame: Assessments will be conducted at baseline (after the screening), 6th week after the baseline, 12th week, and 16th week.
Using [Single-Category Implicit Association Test]: the minimum value is 0 and maximum values is 5, and higher scores mean a positive affective attitude.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LifelongU and Physical education in people with Physical Inactivity and Sedentary Behavior, run by Universiti Sains Malaysia 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 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: status not confirmed, as of the sponsor's last update on 20 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DANDAN HUANG (+8613996265158, dandanh@student.usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (time frame: Assessments will be conducted at baseline (after the screening), 6th week after the baseline, 12th week, and 16th week.). The study lists 3 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 20 Nov 2023.