NCT02345551

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 4, 2015

Status Verified

December 1, 2015

Enrollment Period

5 months

First QC Date

December 16, 2014

Last Update Submit

December 2, 2015

Conditions

Keywords

ExerciseSleepTelemedicineBehaviorShift work

Outcome Measures

Primary Outcomes (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.

    Baseline, 12 weeks

Secondary Outcomes (4)

  • Physical Activity (MET hours per week)

    Baseline, 12 weeks

  • Sedentary Time

    Baseline, 12 weeks

  • Sleep quantity and quality

    Baseline, 12 weeks

  • Quality of Life

    Baseline, 12 weeks

Study Arms (1)

Exercise

EXPERIMENTAL

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.

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

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

Exercise

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \>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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Exercise Physiology Lab

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

Motor ActivityBehavior

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kristin L Campbell, BScPT, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2014

First Posted

January 26, 2015

Study Start

February 1, 2015

Primary Completion

July 1, 2015

Study Completion

October 1, 2015

Last Updated

December 4, 2015

Record last verified: 2015-12

Locations