- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02535754
Interventions to Increase Workplace Wellness
August 26, 2015 updated by: University of British Columbia
Behaviour changes such as improving nutrition, increasing physical activity, and decreasing obesity are linked with lower mortality and morbidity and fewer cancers.
Health promotion programs in the workplace are a promising way to reach a large segment of the population.
This project evaluated the efficacy of three approaches - all of which were based on previous research and programs with demonstrated positive benefits - on cancer-related outcomes (healthy eating, physical activity, normal body weight) and work-related outcomes (absenteeism, presenteeism).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The project evaluated the efficacy of three health promotion interventions on cancer- and work-related outcomes.
Three worksites in British Columbia were randomly assigned to one of three conditions: (1) an empirically-validated intervention directed at individual behavior change using personally-tailored messages delivered by email (ALIVE) ; (2) a comprehensive approach building on social and institutional support developed by the Canadian Cancer Society British Columbia Yukon and previously used for worksite tobacco control (CCS BCY) and (3) an intervention including both of these approaches (CCS BCY + ALIVE).
The primary outcome was change in fruit and vegetable consumption from baseline to 16 months, as an indicator of healthy diet.
Change in weight, physical activity, and work productivity were secondary outcomes.
The investigators also conducted focus groups to assess participant perspectives on the programs which comprise another secondary outcome.
Study Type
Interventional
Enrollment (Actual)
682
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, V6T1Z3
- University of British Columbia
-
-
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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Employee of the company
- English speaking with reading level at Flesch-Kincaid 8.5 grade level
- Ability to provide access to individual work email address
Exclusion Criteria:
- Non-English speaking without reading level at Flesch-Kincaid 8.5 grade level
- Inability to provide access to individual work email address
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ALIVE
Email program N=170
|
The company assigned to this condition offered employees participation in the ALIVE program.
This program was validated in a previous worksite-based randomized controlled trial (RCT).
A baseline assessment includes questions asking about: presence of children at home, habits related to cooking and eating out, physical activity preferences, stage of readiness of change, and perceived barriers to achieving heath behavior goals.
This information provides the basis for immediate feedback and individually-tailored messages that include goal-setting and tips to achieve these goals, interactive features, and health information.
Biweekly messages are sent for a total of 48 weeks.
Outcome data were based on all individuals who completed the baseline assessment.
|
Experimental: CCS BCY
Comprehensive program N=285
|
The company assigned to this condition participated in a comprehensive year-long workplace wellness program intervention focusing on nutrition, weight control, and physical activity, led by the CCS BCY.
The program was modeled after a previous successful CCS BCY tobacco control worksite program.
This program stresses the importance of developing social and environmental supports at the worksite to promote behavior change .
Such supports could include food availability (e.g., cafeteria and vending machine selections), the built environment (e.g., availability of bike racks); social environment (e.g., group lunchtime walking clubs), and health communications (e.g., company newsletters).
Outcome data were based on all individuals who completed the baseline assessment.
|
Experimental: ALIVE + CCS BCY
Email + comprehensive program N=225
|
The company assigned to this condition received both the ALIVE and CCS BCY programs.
Employees were encouraged to take part in both ALIVE and company initiatives, but participation in these activities was based on individual preference.
Outcome data were based on all individuals who completed the baseline assessment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in number of fruit and vegetable servings per day
Time Frame: 16 months
|
Self-reported number of fruit and vegetable servings at baseline and 16 months
|
16 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absenteeism (days)
Time Frame: 16 months
|
Self-reported absenteeism at baseline and 16 months
|
16 months
|
Change in body weight (lbs)
Time Frame: 16 months
|
Self-reported height and weight at baseline and 16 months
|
16 months
|
Physical activity efficacy (minutes)
Time Frame: 16 months
|
Self-reported efficacy for physical activity at baseline and 16 months
|
16 months
|
Participant perspectives on the program (theme)
Time Frame: 16 months
|
Focus groups identified participant responses to the program including strengths and weaknesses.
|
16 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Carolyn C Gotay, 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
April 1, 2010
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
August 24, 2015
First Submitted That Met QC Criteria
August 26, 2015
First Posted (Estimate)
August 31, 2015
Study Record Updates
Last Update Posted (Estimate)
August 31, 2015
Last Update Submitted That Met QC Criteria
August 26, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- H10-01079
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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