Health BehaviorNCT02535754
Interventions to Increase Workplace Wellness
A study testing ALIVE, CCS BCY and ALIVE + CCS BCY in people with Health Behavior, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- ALIVE, CCS BCY and ALIVE + CCS BCY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 682 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-English speaking without reading level at Flesch-Kincaid 8.5 grade level
- Inability to provide access to individual work email address
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T1Z3
About this study
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).
Read the 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.
- Conditions
- Health Behavior
- Being tested
- ALIVE, CCS BCY, ALIVE + CCS BCY
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALIVEBehavioural
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.
CCS BCYBehavioural
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.
ALIVE + CCS BCYBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ALIVE | Experimental | Email program N=170 Receives: Behavioral: ALIVE |
| CCS BCY | Experimental | Comprehensive program N=285 Receives: Behavioral: CCS BCY |
| ALIVE + CCS BCY | Experimental | Email + comprehensive program N=225 Receives: Behavioral: ALIVE + CCS BCY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of fruit and vegetable servings per day
Self-reported number of fruit and vegetable servings at baseline and 16 months
Measured: 16 months
Secondary outcomes (4)
Absenteeism (days)
Self-reported absenteeism at baseline and 16 months
Measured: 16 months
Change in body weight (lbs)
Self-reported height and weight at baseline and 16 months
Measured: 16 months
Physical activity efficacy (minutes)
Self-reported efficacy for physical activity at baseline and 16 months
Measured: 16 months
Participant perspectives on the program (theme)
Focus groups identified participant responses to the program including strengths and weaknesses.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startApr 2010
- Primary completionMar 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 682 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Sponsor
- Investigators
- Carolyn C Gotay, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535754
- Sponsor's protocol ID
- H10-01079
- Status last verified
- Aug 2015
- First submitted
- 24 Aug 2015
- Last updated
- 31 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Increase Workplace Wellness
- ClinicalTrials.gov ID
- NCT02535754
- Acronym / sponsor ID
- H10-01079
- Conditions
- Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 682 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- Apr 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 31 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALIVE | Experimental | Behavioral: ALIVEEmail program N=170 |
| CCS BCY | Experimental | Behavioral: CCS BCYComprehensive program N=285 |
| ALIVE + CCS BCY | Experimental | Behavioral: ALIVE + CCS BCYEmail + comprehensive program N=225 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Non-English speaking without reading level at Flesch-Kincaid 8.5 grade level
- Inability to provide access to individual work email address
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALIVEThe 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. | Behavioural | ALIVE |
| CCS BCYThe 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. | Behavioural | CCS BCY |
| ALIVE + CCS BCYThe 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. | Behavioural | ALIVE + CCS BCY |
Primary outcome
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
4 secondary outcomes
Absenteeism (days)
Time frame: 16 months
Change in body weight (lbs)
Time frame: 16 months
Physical activity efficacy (minutes)
Time frame: 16 months
Participant perspectives on the program (theme)
Time frame: 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn C Gotay, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALIVE, CCS BCY and ALIVE + CCS BCY in people with Health Behavior, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of fruit and vegetable servings per day (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2015.