Health PromotionNCT04538222
Workplace Physical Activity Intervention
An observational study of Health Promotion, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
In this study, it investigates the effectiveness of workplace physical activity intervention for staff in a 100-bed hospital in Taipei City, Taiwan. The physical activity program takes group coaching and includes aerobic exercise, muscle strength and stretching in combination with nutrition education. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Promotion
- What is being tested?
- physical activity
- How many people
- 86 participants
- Where
- 2 sitesTaiwan
- Study dates
- 7 Sep 2020to 4 Aug 2021
- Phase
- Observational
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: individuals who participate hospital self-developed workplace physical activity
Who may be able to join
- full-time employees
- Complete the informed consent
Who cannot join
- With pacemaker
- accepted or are participating participate other weight control related research or interventional medicine
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Taiwan University Hospital
Taipei
National Taiwan University Hospital
Taipei, 新店區, 231
About this study
Official title: An Effectiveness Study of Workplace Physical Activity Intervention for Staff in a Hospital Setting
In this study, it investigates the effectiveness of workplace physical activity intervention for staff in a 100-bed hospital in Taipei City, Taiwan. The physical activity program takes group coaching and includes aerobic exercise, muscle strength and stretching in combination with nutrition education. The duration of the program is three months (8 sessions per month). The subjects of the study were recruited from full-time employees working at the hospital who attend the program. The recruited employees can take part in the program freely and chose types of activity by themselves. This study measures body mass index, muscle strength, body fat percentage, muscle strength, body mass index, daily energy expenditure, and exercise self-efficacy as the baseline. After 3-month program, we will evaluate the effectiveness of the program. The result is anticipated the greater frequent attendance, the more obvious effectiveness in outcomes.
Read the detailed description
A three-month group coaching physical activity program in combination with nutrition education was developed for full-time employees working on a 100-bed hospital in Taipei City, Taiwan. Due to the setting that employees can take part in the program freely and chose types of activity by themselves. So participants may have various intensity of participation. This study aims to evaluate the effectiveness of pre- and post- 3-month workplace physical activity programs in body fat percentage, Muscle strength, body mass index, daily energy expenditure, and exercise self-efficacy. One group pretest-posttest design was used for the study by convenience sampling technique. Subjects were recruited from participants of the program. The intervention consists of : (1)education on nutrition: 2 times per month for 3 months, 1 hour/time ; and (2)physical activity: a three-month group coaching program (24 sessions), including three types of exercise courses such as aerobic exercise, muscle strength and stretching. All analyses were performed using Statistics Analysis System version 9.3 and the effects of the intervention were assessed by the paired t-test. Multiple regression analysis was used to determine the contribution of attendances of activities and behavior change stage to effectiveness of workplace physical activity. The level of significance was set at p < 0.05.
- Conditions
- Health Promotion
- Being tested
- physical activity
- Keywords
- workplace, health promotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activityOther
aerobic exercise, muscle strength and stretching, nutrition education
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Body fat percentage at 3 months
Body fat percentage was the total mass of fat divided by total body mass, multiplied by 100. Estimate for body fat percentage was measured by dual frequency bio-electric impedance(BIA) body composition analyzer.
Measured: baseline, 3 month after intervention
Change from Baseline Muscle strength at 3 months
Muscle strength was assessed by hand grip strength using a grip strength dynamometer. The grip strength dynamometer can measure range from 5 to 100 kg. During the measurement, the subject stood upright and was asked to hold the grip with the dynamometer with the greatest strength. Take the maximum value after two measurements.
Measured: baseline, 3 month after intervention
Change from Baseline exercise self-efficacy at 3 months
The five-item self-efficacy questionnaire designed to measure confidence in one's ability to persist with exercising in various situations which included the following: tired, bad mood, don't have the time, on vacation, raining or snowing. An 7-point scale was used to rate each item of self-efficacy, scores range from 5 "not at all confident" to 35 "very confident". A score of 0 means "extremely low self-efficacy" and a score of 35 means" "extremely high self efficacy"
Measured: baseline, 3 month after intervention
Change from Baseline exercise behavior change stage at 3 months
exercise behavior change stage
Measured: baseline, 3 month after intervention
Secondary outcomes (2)
Change from Baseline body mass index at 3 months
Body mass index (BMI) was calculated as body weight (kg) divided by the square of the body height (meter) (m2). BMI was assessed using a body composition analyzer.
Measured: baseline, 3 month after intervention
Change from Baseline Daily energy expenditure at 3 months
Daily energy expenditure as an estimate of total kilo-calories of energy expended per day. Calculation from the seven-day physical activity recall questionnaire. Subjects were asked to list total activities in each category and quantifying the time spent (hour) in each activity over a seven-day period. Activities were classified by their energy requirements, expressed in terms of Metabolic Equivalent of Task (MET). Sleep = 1 MET; light activity = 1.0-2.9 MET (MET level: 1.5); moderate activity = 3.0-5.0 MET (MET level: 4); hard activity =5.1-6.9 MET (MET level: 6); very hard activity = 7.0 or greater MET (MET level: 10). Each activity's total kilo-calories of energy expended per day was calculated by the following equation: activity MET * times of having activity time(hours)*body weight(kg)/7 (day).
Measured: baseline, 3 month after 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 2020
- Study start7 Sep 2020
- Primary completion13 Nov 2020
- Study completion4 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health PromotionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538222
- Sponsor's protocol ID
- 202007050RIND
- Status last verified
- Aug 2020
- First submitted
- 25 Aug 2020
- Last updated
- 18 Aug 2022
- 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 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Effectiveness Study of Workplace Physical Activity Intervention for Staff in a Hospital Setting
- ClinicalTrials.gov ID
- NCT04538222
- Acronym / sponsor ID
- 202007050RIND
- Conditions
- Health Promotion
- Keywords
- workplace, health promotion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 13 Nov 2020 (actual)
- Study completion
- 4 Aug 2021 (actual)
- First posted
- 4 Sep 2020 (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.
In this study, it investigates the effectiveness of workplace physical activity intervention for staff in a 100-bed hospital in Taipei City, Taiwan. The physical activity program takes group coaching and includes aerobic exercise, muscle strength and stretching in combination with nutrition education. The duration of the program is three months (8 sessions per month). The subjects of the study were recruited from full-time employees working at the hospital who attend the program. The recruited employees can take part in the program freely and chose types of activity by themselves. This study measures body mass index, muscle strength, body fat percentage, muscle strength, body mass index, daily energy expenditure, and exercise self-efficacy as the baseline. After 3-month program, we will evaluate the effectiveness of the program. The result is anticipated the greater frequent attendance, the more obvious effectiveness in outcomes.
Detailed description
A three-month group coaching physical activity program in combination with nutrition education was developed for full-time employees working on a 100-bed hospital in Taipei City, Taiwan. Due to the setting that employees can take part in the program freely and chose types of activity by themselves. So participants may have various intensity of participation. This study aims to evaluate the effectiveness of pre- and post- 3-month workplace physical activity programs in body fat percentage, Muscle strength, body mass index, daily energy expenditure, and exercise self-efficacy. One group pretest-posttest design was used for the study by convenience sampling technique. Subjects were recruited from participants of the program. The intervention consists of : (1)education on nutrition: 2 times per month for 3 months, 1 hour/time ; and (2)physical activity: a three-month group coaching program (24 sessions), including three types of exercise courses such as aerobic exercise, muscle strength and stretching. All analyses were performed using Statistics Analysis System version 9.3 and the effects of the intervention were assessed by the paired t-test. Multiple regression analysis was used to determine the contribution of attendances of activities and behavior change stage to effectiveness of workplace physical activity. The level of significance was set at p < 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- individuals who participate hospital self-developed workplace physical activity
Key inclusion criteria (2 listed)
- full-time employees
- Complete the informed consent
Key exclusion criteria (2 listed)
- With pacemaker
- accepted or are participating participate other weight control related research or interventional medicine
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 |
|---|---|---|
| physical activityaerobic exercise, muscle strength and stretching, nutrition education | Other | – |
Primary outcome
Change from Baseline Body fat percentage at 3 months
Time frame: baseline, 3 month after intervention
Body fat percentage was the total mass of fat divided by total body mass, multiplied by 100. Estimate for body fat percentage was measured by dual frequency bio-electric impedance(BIA) body composition analyzer.
Change from Baseline Muscle strength at 3 months
Time frame: baseline, 3 month after intervention
Muscle strength was assessed by hand grip strength using a grip strength dynamometer. The grip strength dynamometer can measure range from 5 to 100 kg. During the measurement, the subject stood upright and was asked to hold the grip with the dynamometer with the greatest strength. Take the maximum value after two measurements.
Change from Baseline exercise self-efficacy at 3 months
Time frame: baseline, 3 month after intervention
The five-item self-efficacy questionnaire designed to measure confidence in one's ability to persist with exercising in various situations which included the following: tired, bad mood, don't have the time, on vacation, raining or snowing. An 7-point scale was used to rate each item of self-efficacy, scores range from 5 "not at all confident" to 35 "very confident". A score of 0 means "extremely low self-efficacy" and a score of 35 means" "extremely high self efficacy"
Change from Baseline exercise behavior change stage at 3 months
Time frame: baseline, 3 month after intervention
exercise behavior change stage
2 secondary outcomes
Change from Baseline body mass index at 3 months
Time frame: baseline, 3 month after intervention
Change from Baseline Daily energy expenditure at 3 months
Time frame: baseline, 3 month after intervention
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 18 Aug 2022.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Promotion, run by National Taiwan University Hospital at 2 sites in Taiwan.
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 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
Change from Baseline Body fat percentage at 3 months (time frame: baseline, 3 month after intervention). The study lists 4 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 18 Aug 2022.