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Working on Wellness (WOW) Intervention (WOW)

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ClinicalTrials.gov Identifier: NCT01494207
Recruitment Status : Unknown
Verified February 2012 by Tracy Kolbe-Alexander, University of Cape Town.
Recruitment status was:  Active, not recruiting
First Posted : December 16, 2011
Last Update Posted : February 27, 2012
VU University of Amsterdam
Information provided by (Responsible Party):
Tracy Kolbe-Alexander, University of Cape Town

Brief Summary:

The main aim of this study is to measure the effectiveness of a worksite health promotion programme on improving physical activity behaviour and associated biological risk factors for cardiovascular disease among South African employees at increased risk for cardiovascular diseases. Additionally, the investigators will conduct an economic evaluation to determine the associated cost- effectiveness of these health related interventions offered at South African companies.

The investigators hypothesize that employees who receive the intervention counseling will have increased levels of physical activity and reduced risk for cardiovascular disease compared to those in the control group.

Condition or disease Intervention/treatment
Physical Activity Behavioral: Wellness counseling

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Working on Wellness (WOW): A Worksite Health Promotion Intervention Programme
Study Start Date : November 2009
Primary Completion Date : May 2011
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lifestyle intervention
Participants will receive the intervention (counseling) or usual care (control group)
Behavioral: Wellness counseling
Each participant will receive up to six counseling sessions where the counselor will employ motivational interviewing techniques. The first and last session will be face-to-face with the remaining four sessions being telephonic.
Other Name: Motivational Interviewing counseling

Primary Outcome Measures :
  1. Effectiveness of a worksite intervention on physical activity behavior [ Time Frame: 12 months ]
    The Global Physical Activity Questionnaire will be used for self reported levels of physical activity. Weekly time spent in moderate and vigorous activity will be reported.

Secondary Outcome Measures :
  1. Risk for cardiovascular disease [ Time Frame: 12 months ]
    The risk for cardiovascular disease will be based on blood pressure and cholesterol measurements, Body Mass Index, smoking status and dietary behavior

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Employees identified to be at 'increased' or 'high' risk for CVD are eligible to take part in the research study. Risk status will be determined by using the (Euro) SCORE 12, together with their habitual physical activity levels, and Body Mass Index. SCORE incorporates age, total cholesterol, blood pressure and smoking status. This score ranks individuals according to their level of risk, ranging from very low to very high 10-year risk of fatal CVD (Appendix 1). Those with a risk of 5% or higher will be considered eligible.

Independent of the risk score, employees who are inactive (i.e., who do not comply with at least 30 minutes of moderate to vigorous activity on at least 5 days per week), or who smoke, and employees who are overweight (i.e., Body Mass Index ≥ 25 kg/m2) also will be eligible to take part in the study. Other inclusion criteria include being older than 18 years and having a contract with employer until end of 12-month measurement period

Exclusion Criteria:

  • Employees will be excluded for the following reasons: pregnancy, diagnosis or treatment of cancer, any other disorder that makes physical activity impossible. Contract workers whose employ with the company will end before the 12 month follow up measurement, will also be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01494207

South Africa
University of Cape Town
Cape Town, South Africa, 7725
Sponsors and Collaborators
University of Cape Town
VU University of Amsterdam
Principal Investigator: Tracy L Kolbe-Alexander, PhD University of Cape Town

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tracy Kolbe-Alexander, Senior Lecturer, University of Cape Town
ClinicalTrials.gov Identifier: NCT01494207     History of Changes
Other Study ID Numbers: REC Ref 044/2009
First Posted: December 16, 2011    Key Record Dates
Last Update Posted: February 27, 2012
Last Verified: February 2012

Keywords provided by Tracy Kolbe-Alexander, University of Cape Town:
motivational interviewing
physical activity