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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
682

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ALIVE
Email program N=170
Behavioral: ALIVE
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
Behavioral: CCS BCY
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
Behavioral: ALIVE + CCS BCY
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Cancer Society (CCS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings