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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02535754
Other study ID # H10-01079
Secondary ID
Status Completed
Phase N/A
First received August 24, 2015
Last updated August 26, 2015
Start date April 2010
Est. completion date March 2014

Study information

Verified date August 2015
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical 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. 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 682
Est. completion date March 2014
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
Canada University of British Columbia Vancouver British Columbia

Sponsors (2)

Lead Sponsor Collaborator
University of British Columbia Canadian Cancer Society Research Institute (CCSRI)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in number of fruit and vegetable servings per day Self-reported number of fruit and vegetable servings at baseline and 16 months 16 months No
Secondary Absenteeism (days) Self-reported absenteeism at baseline and 16 months 16 months No
Secondary Change in body weight (lbs) Self-reported height and weight at baseline and 16 months 16 months No
Secondary Physical activity efficacy (minutes) Self-reported efficacy for physical activity at baseline and 16 months 16 months No
Secondary Participant perspectives on the program (theme) Focus groups identified participant responses to the program including strengths and weaknesses. 16 months No
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