Working on Wellness (WOW) Intervention

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Cape Town.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
VU University of Amsterdam
Information provided by (Responsible Party):
Tracy Kolbe-Alexander, University of Cape Town
ClinicalTrials.gov Identifier:
NCT01494207
First received: December 14, 2011
Last updated: February 24, 2012
Last verified: February 2012
  Purpose

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 Intervention
Physical Activity
Behavioral: Wellness counseling

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Working on Wellness (WOW): A Worksite Health Promotion Intervention Programme

Further study details as provided by University of Cape Town:

Primary Outcome Measures:
  • Effectiveness of a worksite intervention on physical activity behavior [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Risk for cardiovascular disease [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The risk for cardiovascular disease will be based on blood pressure and cholesterol measurements, Body Mass Index, smoking status and dietary behavior


Enrollment: 800
Study Start Date: November 2009
Estimated Study Completion Date: June 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494207

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

No publications provided by University of Cape Town

Additional 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
Study First Received: December 14, 2011
Last Updated: February 24, 2012
Health Authority: South Africa: Human Research Ethics Committee

Keywords provided by University of Cape Town:
worksite
interventions
motivational interviewing
physical activity

ClinicalTrials.gov processed this record on April 16, 2014