A Physical Activity Intervention for Female Shift Workers (SWPA)

December 2, 2015 updated by: University of British Columbia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • Clinical Exercise Physiology Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • >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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
The 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.
Moderate-vigorous aerobic activity in line with published guidelines for cancer prevention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility: A composite outcome of overall feasibility will be assessed as the primary outcome.
Time Frame: Baseline, 12 weeks
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.
Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity (MET hours per week)
Time Frame: Baseline, 12 weeks
Accelerometry (Actigraph GT3x+)
Baseline, 12 weeks
Sedentary Time
Time Frame: Baseline, 12 weeks
Accelerometry (Actigraph GT3x+)
Baseline, 12 weeks
Sleep quantity and quality
Time Frame: Baseline, 12 weeks
Pittsburgh sleep quality index
Baseline, 12 weeks
Quality of Life
Time Frame: Baseline, 12 weeks
SF-36
Baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kristin L Campbell, BScPT, PhD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

December 16, 2014

First Submitted That Met QC Criteria

January 23, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Estimate)

December 4, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • H14-03408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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