Life Style, Physical Activity, Sedentary Behavior
Conditions
Keywords
Life style disease, Obesity, Sedentary behaviour, Cardiovascular biomarkers
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALLife style intervention
Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention.
Sponsors
Lundbeck Foundation
Sygekassernes Helsefond
Glostrup University Hospital, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Minimum selfreported 3 ½ hours of sedentary leisure time per day
Exclusion criteria
* More than 8 hours of vigorous activity per week * Physical handicap or illness that prevent reduction of sitting time * Must be able to read and understand Danish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Objectively Measured Sitting Time From Baseline to 6 Months Follow-up | 7 days of measurement / change in sitting time from baseline and 6 months follow-up | Participants wore an ActivePAL monitor for seven days at inclusion and seven days at follow-up. The ActivePAL measures sitting time. Change in sitting time from baseline to 6 months follow up was evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in High Density Lipoprotein (HDL) From Baseline to 6 Months Follow-up. | Change in measured HDL from baseline and 6 months follow-up | Blood samples are drawn at inclusion and at 6 months follow-up. Change in measured HDL (mmol/L) from baseline to 6 months follow-up |
Countries
Denmark
Participant flow
Pre-assignment details
171 participants were consecutively included. However 5 patients withdrew before randomisation, leaving 166 participants to be included and randomised to either the intervention or the control group. Reasons for withdrawal were: 4 participants changed their mind because of lack of time, 1 participant reported skin reaction to monitor attachment.
Participants by arm
| Arm | Count |
|---|---|
| Lifestyle Counselling Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.
Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention. | 93 |
| Control Group No intervention control group | 73 |
| Total | 166 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Withdrawal by Subject | 11 | 5 |
Baseline characteristics
| Characteristic | Lifestyle Counselling | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 52.2 years STANDARD_DEVIATION 13.8 | 51.8 years STANDARD_DEVIATION 14.3 | 52 years STANDARD_DEVIATION 14 |
| Region of Enrollment Denmark | 93 participants | 73 participants | 166 participants |
| Sex: Female, Male Female | 59 Participants | 36 Participants | 95 Participants |
| Sex: Female, Male Male | 34 Participants | 37 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 93 | 0 / 73 |
| serious Total, serious adverse events | 0 / 93 | 0 / 73 |
Outcome results
Primary
Change in Objectively Measured Sitting Time From Baseline to 6 Months Follow-up
Participants wore an ActivePAL monitor for seven days at inclusion and seven days at follow-up. The ActivePAL measures sitting time. Change in sitting time from baseline to 6 months follow up was evaluated.
Time frame: 7 days of measurement / change in sitting time from baseline and 6 months follow-up
Population: Within group difference
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Counselling | Change in Objectively Measured Sitting Time From Baseline to 6 Months Follow-up | -0.27 Hours per day | Standard Deviation 1.7 |
| Control Group | Change in Objectively Measured Sitting Time From Baseline to 6 Months Follow-up | 0.06 Hours per day | Standard Deviation 1.7 |
Secondary
Change in High Density Lipoprotein (HDL) From Baseline to 6 Months Follow-up.
Blood samples are drawn at inclusion and at 6 months follow-up. Change in measured HDL (mmol/L) from baseline to 6 months follow-up
Time frame: Change in measured HDL from baseline and 6 months follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Counselling | Change in High Density Lipoprotein (HDL) From Baseline to 6 Months Follow-up. | -0.03 mmol/Liter | Standard Deviation 0.2 |
| Control Group | Change in High Density Lipoprotein (HDL) From Baseline to 6 Months Follow-up. | -0.02 mmol/Liter | Standard Deviation 0.2 |