NCT01494207

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 27, 2012

Status Verified

February 1, 2012

Enrollment Period

1.5 years

First QC Date

December 14, 2011

Last Update Submit

February 24, 2012

Conditions

Keywords

worksiteinterventionsmotivational interviewingphysical activity

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of a worksite intervention on physical activity behavior

    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.

    12 months

Secondary Outcomes (1)

  • Risk for cardiovascular disease

    12 months

Study Arms (1)

Lifestyle intervention

EXPERIMENTAL

Participants will receive the intervention (counseling) or usual care (control group)

Behavioral: Wellness counseling

Interventions

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.

Also known as: Motivational Interviewing counseling
Lifestyle intervention

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cape Town

Cape Town, 7725, South Africa

Location

Related Publications (1)

  • Kolbe-Alexander TL, Proper KI, Lambert EV, van Wier MF, Pillay JD, Nossel C, Adonis L, Van Mechelen W. Working on wellness (WOW): a worksite health promotion intervention programme. BMC Public Health. 2012 May 24;12:372. doi: 10.1186/1471-2458-12-372.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Tracy L Kolbe-Alexander, PhD

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

December 14, 2011

First Posted

December 16, 2011

Study Start

November 1, 2009

Primary Completion

May 1, 2011

Study Completion

June 1, 2012

Last Updated

February 27, 2012

Record last verified: 2012-02

Locations