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Physical ActivitySWPANCT02345551

A Physical Activity Intervention for Female Shift Workers

A study testing Exercise in people with Physical Activity, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project will assess the feasibility of a 12-week physical activity program developed specifically for females exposed to a known occupational carcinogen - shiftwork. Physical activity has been shown to decrease cancer risk, but the investigators research has found that female shift workers face unique barriers to… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Physical Activity
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
Feb 2015to Oct 2015
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Premenopausal
  • Live/work in the greater Vancouver area or willing to come to Vancouver for baseline visit
  • Able to read, speak and understand english
  • Work a job requiring high circadian disruption (at least 5 night shifts per month) for at least 3 years
  • Telephone and internet access

Who cannot join

  • >90 minutes per week of moderate-vigorous physical activity
  • Answer 'Yes' to any question on the PAR-Q
  • Pregnant or planning to become pregnant
  • BMI > 40.0 kg/m2

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Clinical Exercise Physiology Lab

    Vancouver, British Columbia, V6T 1Z3

Other trials in Canada

About this study

Official title: The Feasibility of a Telephone and Web-based Physical Activity Intervention for Female Shift Workers.

This project will assess the feasibility of a 12-week physical activity program developed specifically for females exposed to a known occupational carcinogen - shiftwork. Physical activity has been shown to decrease cancer risk, but the investigators research has found that female shift workers face unique barriers to participating in physical activity. This project will use a combination of telephone-based behavioural counseling sessions with a physical activity coach, and innovative web-based physical activity tracking software using a Fitbit and website or smartphone app to address commonly reported barriers to physical activity in female shift workers.

Read the detailed description

Currently 4.1 million Canadians are employed in shiftwork. Shiftwork, defined as the organization of working time to cover more than the usual 8-hour workday and up to a 24-hour period, is prevalent in health care, emergency services, manufacturing, retail and hospitality. Given the growing demand for goods and services at all hours in today's society, the number of shift workers is unlikely to decrease. There is emerging evidence that shiftwork has many negative health implications, including a higher risk of cancer and other chronic diseases. A recent systematic review by members of the investigators study team reported preliminary evidence that changes in shift scheduling, timed exposure to bright light during a night shift, and pharmacological therapy for sleep, help to improve sleep and markers of circadian rhythm dysfunction in shift workers. However changes in shift schedules, and exposure to bright light may be difficult to implement in certain workplaces (i.e., specific hospital environments, police patrol cars) and long-term effects of pharmacological therapy are unknown. To date there is very limited research on effective health promotion strategies in this occupational group, who face unique challenges to engaging in health behaviour change. There is an urgent need to develop and evaluate interventions to improve health and reduce cancer risk in this high-risk population. Participation in regular physical activity is known to decrease risk of cancer and other chronic diseases, and may be a simple and cost-effective intervention that could be implemented in workplaces and by individual workers to mitigate this increased risk. Shift workers have unique barriers to participating in physical activity; therefore the feasibility of implementing such interventions must first be investigated.

Objective 1: To assess the feasibility of a 12-week telephone and web-based physical activity intervention in female shift workers, including recruitment, retention, adherence and acceptability of the intervention.

Objective 2: To explore changes in physical activity (min/week), health behaviours (i.e., sedentary time, sleep), and quality of life that may occur during the intervention in preparation for a full randomized controlled trial (RCT) if the intervention is found to be feasible.

Research Methods:

As the aim of the study is to evaluate feasibility, the investigators will use a single-group pre-post intervention design.

The behaviour change intervention to promote an increase in min/week of moderate-vigorous physical activity will be guided by the Health Action Process Approach (HAPA) model. This model aims to promote behaviour change through increasing self-efficacy for intention, planning and maintenance of physical activity. The goal is for participants to meet Canada's Physical Activity Guidelines for adults of 150 min/week of moderate-vigorous physical activity.

As a compliment to the behavioural counseling sessions, participants will be asked to track their physical activity. All participants will be given a FitBit wrist-worn activity monitor (www.fitbit.com) which monitors step counts, distance covered, and active minutes and also tracks sleep. The FitBit synchronizes wirelessly to the participants' computer and/or smartphones, thus minimizing the need for daily data entry tracking by participants.

Being tested
Exercise
Keywords
Exercise, Sleep, Telemedicine, Behavior, Shift work
Medical subject headings
Motor Activity, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    Moderate-vigorous aerobic activity in line with published guidelines for cancer prevention

Study groups in NCT02345551
Study groupRoleWhat they receive
ExerciseExperimentalThe behaviour change intervention to promote an increase in moderate-vigorous physical activity (to meet the cancer prevention guidelines of 150 min/week) will be guided by the Health Action Process Approach (HAPA) model. This model aims to promote behaviour change through increasing self-efficacy for intention, planning and maintenance of physical activity. As a compliment to the behavioural counseling sessions, participants will be asked to track their physical activity using the FitBit, a wrist-worn activity monitor (www.fitbit.com) which monitors step counts, distance covered, and active minutes and also tracks sleep. The FitBit synchronizes wirelessly to the participants' computer and/or smartphones, thus minimizing the need for daily data entry tracking by participants.
Receives: Behavioral: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility: A composite outcome of overall feasibility will be assessed as the primary outcome.

    We will consider the intervention to be feasible if all of the following conditions are met: 1) Achieve a recruitment goal of 20 participants in three months; 2) Achieve a retention rate of 80% of enrolled participants; 3) Achieve > 80% adherence to behavioral counseling sessions; and 4) >80% of participants rank their satisfaction with the study as "Satisfied" (4) or "Very Satisfied" (5) on a five-point Likert scale.

    Measured: Baseline, 12 weeks

Secondary outcomes (4)
  1. Physical Activity (MET hours per week)

    Accelerometry (Actigraph GT3x+)

    Measured: Baseline, 12 weeks

  2. Sedentary Time

    Accelerometry (Actigraph GT3x+)

    Measured: Baseline, 12 weeks

  3. Sleep quantity and quality

    Pittsburgh sleep quality index

    Measured: Baseline, 12 weeks

  4. Quality of Life

    SF-36

    Measured: Baseline, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionJul 2015
  4. Study completionOct 2015

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02345551
Sponsor's protocol ID
H14-03408
Acronym
SWPA
Status last verified
Dec 2015
First submitted
16 Dec 2014
Last updated
4 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Physical Activity, run by University of British Columbia at 1 site in Canada.

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 5 inclusion and 4 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 4 Dec 2015. 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 Canada. 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?

Feasibility: A composite outcome of overall feasibility will be assessed as the primary outcome. (time frame: Baseline, 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 4 Dec 2015; AzTrials last refreshed its copy on 30 Oct 2026.

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