Condition category
Not Applicable
Date applied
22/08/2018
Date assigned
02/07/2019
Last edited
05/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Past clinical experiences and medical research have shown that health promotion programmes usually fail to last for a long period, or do not demonstrate promising effects. This can be particularly a problem in healthcare professionals, especially those who have to work on shifts. This study aims to look at if using body motion sensors in a health promotion programme will help attendees (healthcare professionals) to do more for their health.

Who can participate?
Adult healthcare professionals in the Tsaotun Psychiatric Centre in Taiwan, who do shift work

What does the study involve?
The participants will be randomly assigned to two groups - the intervention and control groups. The intervention group will receive an active motion sensor, whereas the control group will receive a disabled sensor. Both groups will be asked to wear the motion sensor for most of the day during the period of the study. All participants will be encouraged to attend to the 24-week health promotion programme.

What are the possible benefits and risks of participating?
We expect that all the participants in the study will benefit from attending to the health promotion programme. However, the benefit may be larger for the people in the intervention group, as they will have access to their exercise information. There are no known risks to participants taking part in this study.

Where is the study run from?
Tsaotun Psychiatric Centre (Taiwan)
All the activities in the health promotion programme will be held in a government-run mental hospital in central Taiwan and will take place at the time after regular work. All the study, including the body motion sensors will be funded by the research grant offered by the hospital, and there will be no additional cost for the participants.

When is the study starting and how long is it expected to run for?
October 2017 to March 2019

Who is funding the study?
Tsaotun Psychiatric Centre (Taiwan)

Who is the main contact?
Ms. Wang (Ya-Hui Wang)
yhwang@ttpc.mohw.gov.tw

Trial website

Contact information

Type

Scientific

Primary contact

Dr Yung-Jen Yang

ORCID ID

Contact details

No 161
Yu-Ping Road
Tsao-Tun Township
Nan-Tou County
54249
Taiwan

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

107013

Study information

Scientific title

The effectiveness of motion sensors in a health promotion programme for healthcare staff on shift work: a randomised controlled trial

Acronym

Study hypothesis

Motion senors may improve the effectiveness of an existent health promotion programme.

Ethics approval

Tsaotun Psychiatric Center, 02/04/2018, IRB number: 106055

Study design

Interventional single-centre assessor-blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Health behaviours of healthcare staff on shift work

Intervention

An independent research agent will use computer statistical software to generate random sequence numbers for allocating participants into the intervention and control groups. The generated number for each participant will be sealed in an opaque envelope and then delivered to the research team members for recruitment. Each participate will receive their number and motion sensor in the envelope. The motion sensors will be pre-set according to the group they belong to - for the intervention group, they will be active; for the control group, they will be disabled. Participants in both groups will be asked to wear the motion sensor for most of each day of the study period. Participants in both groups are asked to attend to a 24-week health programme, in which a weekly aerobic physical exercise training course will be instructed and assigned. In the programme, participants in both groups will be asked to record their daily health-related profiles in a health log. The research team will also provide health promotion information, including the ways to control body weight, healthy diets, tips for health behaviours.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measure

1. Attendance rate to the health promotion programme, assessed by tracking how many times participants attend the programme over the course of the 24 week programme
2. Completeness of daily personal health behaviour log, assessed using the total number of completed logs at the end of the 24 week programme

Secondary outcome measures

All secondary outcome measures will be assessed by 2 members of the research group who are blind to the assigned group of the participants and will be assessed at the baseline, after 12 weeks and after 24 weeks (end of the intervention):
1. Objective measurements including changes in the following:
1.1. Physical efficiency index (PEI), assessed by measuring heart rate after exercise according to the Harvard Step Test
1.2. Body mass index (BMI), assessed using personal bodymetrics (weight in kg divided by height in m, squared (kg/m²))
1.3. Body fat, assessed using skinfold calipers at the biceps, triceps, subscapular and suprailiac areas
2. Subjective measurements, including the following:
2.1. Self-developed questionnaires measuring health behaviours
2.2. EuroQol-5D (EQ-5D)
2.3. General Self-Efficacy Scale (GSES)

Overall trial start date

02/10/2017

Overall trial end date

31/03/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years or older
2. Health care professionals
3. Shift work
4. Working in a mental hospital (Tsaotun Psychiatric Centre)

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Unable to participate in the health promotion programmes for any reason
2. Unable to wear motion sensors for most of a single day during the period of study

Recruitment start date

01/09/2018

Recruitment end date

14/09/2018

Locations

Countries of recruitment

Taiwan

Trial participating centre

Tsaotun Psychiatric Centre
No 161, Yu-Ping Road, Tsao-Tun Township
Nan-Tou County
54249
Taiwan

Sponsor information

Organisation

Tsao-Tun Psychiatric Center, Ministry of Health and Welfare, Executive Yuan

Sponsor details

No. 161
Yu-Ping Road
Tsao-Tun Township
Nan-Tou County
54249
Taiwan

Sponsor type

Hospital/treatment centre

Website

http://www.ttpc.mohw.gov.tw

Funders

Funder type

Government

Funder name

Tsao-Tun Psychiatric Center, Ministry of Health and Welfare, Executive Yuan

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan to present our results at an international health-related scientific conference. We also plan to publish our results in a high-impact peer-reviewed journal in 2020.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

01/03/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/07/2019: Internal review.