The main objective of the study is to evaluate the effectiveness of an individually- based lifestyle intervention for male workers with an elevated CVD risk in the construction industry in The Netherlands.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Lifestyle factors:
Physical activity: Frequency, duration and intensity of PA in leisure time.
Fulfilling Dutch PA norms (NNGB and Fitnorm)
Diet: Intake of fruit, vegetables, fish
Intake of sodas, snacks, alcohol, sugar,
Amount of bread, number of portions
Smoking: yes/ no
Secondary outcome
Biomedical variables:
BMI (kg/m2)
Total cholesterol (mmol/l),
HDL-cholesterol (mmol/l)
Systolic blood pressure (mmHg),
Diastolic blood pressure mmHg),
HbA1c (%)
Other factors:
Fitness (deduced from resting heart rate, BMI, age and self reported PA)
Stage of change
Perceived general health
Absenteeism
Cost-effectiveness
Background summary
In The Netherlands, cardiovascular diseases (CVD) are responsible for 33% of
total mortality each year. Among those working in the construction industry,
many suffer from one or more risk factors for CVD; in 2005 > 60% had
overweight, >33% was a smoker, 40% did not meet any of the Dutch Guidelines
for physical activity. Improving lifestyle has been proven an effective
strategy for lowering the risk for CVD.
Study objective
The main objective of the study is to evaluate the effectiveness of an
individually- based lifestyle intervention for male workers with an elevated
CVD risk in the construction industry in The Netherlands.
Study design
The study is a randomized controlled trial. 700 participants will be included,
of whom 350 are allocated to the intervention group and 350 to the control
group. After the baseline meaurement (Periodical Occupational Health Check;
PAGO) workers will be invited to partipate and receive a questionnaire. The
inflow is continuous. Duration of the intervention is six months. The control
group receives usual care. Six and twelve months after the start of the
intervention, health measurements (comparable to the PAGO) will take place at
the Health Service and all participants will be asked to fill in a
questionnaire.
Intervention
For each participant, the intervention comprises three face to face contacts at
the arbodienst (45 - 60 minutes each) and four telephone conversations (15-30
minutes each).
The individual counseling will be carried out by a professional health
counselor employed at the Health Service (occupational physician or
occupational nurse).
Counseling will be in the style of Motivational Interviewing. Benefits and
barriers for change will be discussed. The stage of change of the participant
will be taken into account. If desired, oral advice about changing lifestyle
will be given.
Furthermore, written information about healthy lifestyle will be provided, e.g.
from the Dutch Heart Foundation and the Dutch Nutrition Centre.
Study burden and risks
Benefit for the participant is improving lifestyle and reducing CVD risk.
This will be achieved by
- Support in changing lifestyle by e.g. discussing barriers and benefits;
- Advice about healthy lifestyle, oral as well as on paper.
It takes about 6 hours to complete the whole intervention (counselling,
measurements and filling out forms). If the participant does not want to visit
the Health Service for the face to face contact, a home visit can be arranged
withthe counsellor.
The participant has to visit the Health Service twice (T= 6 months and T=12
months) for an extra health check. Some may not regard this as a burden but as
a benefit; by this means all participants, also the ones in the control group,
will be informed about their health.
During the health checks, blood pressure and resting heart rate will be
measured and blood will be drawn from the participant. This will be done
following the same procedure as in the PAGO; thus this is a familiar to the
participant.
Van der Boechorststraat 7
1081 BT Amsterdam
Nederland
Van der Boechorststraat 7
1081 BT Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Male, aged 18-55, working in construction industry
Signed an informed consent form
Elevated risk of cardiovascular disease based on:
The Framingham Risk Score AND one or more of the following:
BMI ><= 30 kg/m2; HbA1c > 6.5%; Alcohol abstinence or > 35 consumptions per week; Psychological complaints, Cardiovascular complaints; Not fulfilling both Dutch physical activity norms (NNGB and Fitnorm). Also see section 4.1, page 13-14 in the protocol.
Exclusion criteria
Inable to be physically active;
Not sufficiently capable of using the Dutch language;
Not having signed an informed consent form
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL15734.029.06 |