- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02345551
A Physical Activity Intervention for Female Shift Workers (SWPA)
The Feasibility of a Telephone and Web-based Physical Activity Intervention for Female Shift Workers.
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
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Vancouver, British Columbia, Canada, V6T 1Z3
- Clinical Exercise Physiology Lab
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Baseline, 12 weeks
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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
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Accelerometry (Actigraph GT3x+)
|
Baseline, 12 weeks
|
Sleep quantity and quality
Time Frame: Baseline, 12 weeks
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Pittsburgh sleep quality index
|
Baseline, 12 weeks
|
Quality of Life
Time Frame: Baseline, 12 weeks
|
SF-36
|
Baseline, 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kristin L Campbell, BScPT, PhD, University of British Columbia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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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