Physical Activity Clinical Trial
Official title:
Reduction of Sitting Time - a Randomized Controlled Intervention Study
Recent studies have suggested that prolonged daily sitting time may in itself have a
negative effect on health, even in people who engage in daily physical activity.
The aim of the present study is to explore whether individually tailored lifestyle
counselling aimed at reducing TV-viewing and other sedentary activities during leisure time
and at work, can reduce sitting time and waist circumference, weight and blood pressure; and
improve serum lipid levels. From a population-based health survey, 150 adult men and women
with more than 3.5 hours of daily leisure time sitting time are recruited and randomly
assigned to 1) an intervention group or 2) a control group. The intervention group will
participate in 4 individually tailored lifestyle intervention sessions focussing on
reduction of daily sitting time. The control group will receive no intervention.
Evidence for the health benefits of regular physical activity is clear and unanimous.
Recently, observational studies have found that prolonged bouts of sitting time are
associated with chronic disease and mortality, even in individuals who engage in regular
physical activity. These new findings indicate that sedentary behaviour should be regarded
as a distinct class of behaviour with independent effects on disease risk, separate from the
behaviour of leisure time physical activity. Prolonged daily sitting time is prevalent in
modern, western society, making further exploration into this field of research a relevant
public health issue.
It remains to be tested, whether it is possible to reduce sedentary leisure time in adults
and whether a reduction of sedentary leisure time will lead to a decrease in biological CVD
risk factors.
The investigators hypothesize that sedentary behaviour during leisure time and at work may
be reduced through a theory-based individually tailored lifestyle intervention.
Aim: To examine whether an individually tailored lifestyle intervention aimed at reducing
TV-viewing and other sedentary activities during leisure time and at work, can reduce
sitting time, waist circumference, BMI and blood pressure; and improve serum lipid level.
Study population: From the "Health2010" study, that was initiated February 2010 at the RCPH,
150 sedentary participants will be consecutively invited and randomised by
computer-generated random numbers into A) an intervention group (n=75) and B) a control
group (n=75), when visiting the RCPH for the health examination. The entire Health2010
population will comprise 4.000 men and women between 19 and 69 years of age.
Control group: The control group will be instructed to maintain their usual lifestyle,
including physical activity level and sedentary behaviour. After the intervention period is
terminated, participants in the control group will be given the written material (booklets
etc.).
Primary outcome measure: Time engaging in sedentary activities (hours & minutes per day), as
measured by ActivPAL. Secondary outcome measures: self-reported physical activity and
sitting time, total cholesterol, HDL, triglycerides, LDL, weight, waist circumference,
systolic and diastolic blood pressure. Outcome measures will be obtained at baseline
(inclusion) and after 6 months.
A possible effect of the intervention on self-reported sedentary leisure time (primary
outcome) and biological CVD risk factors (secondary outcomes) will be explored by comparison
of intervention and control group at baseline and follow-up. Regression analysis and
intention-to-treat analysis will be applied and a significance level of 0.05 will be used.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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