Life Style, Mindfulness, Physical Activity
Conditions
Brief summary
In a pilot study, 90 physically inactive patients will be opportunistically and consecutively recruited and randomized to three intervention groups: mindfulness training, Physical Activity on Prescription (PAP) or only PAP. Follow-up will be done at baseline, three and six months with questionnaires, accelerometers and analysis of traditional risk factors to evaluate whether mindfulness may increase physical activity and decrease physical inactivity.
Detailed description
All patients between 40 and 65 years of age who fulfil the inclusion criteria will be asked to participate in the study. Posters with information about the study will be put in the waiting room and in other strategic places. Patients who accept to participate will get written and oral information; they will sign an informed consent after the information. The patients will estimate their level of physical activity in minutes per week to control inclusion criteria. The patients will return in the morning for fasting blood samples and get an accelerometer attached to them to wear for 7 days. During this time, randomization will be performed. They will also get to answer a couple of different surveys. The results from the surveys and blood samples will be the study baseline. All patients with abnormal test results will follow a specific flow diagram for the usual care.
Interventions
BEHAVIORALMindfulness
Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day
BEHAVIORALPAP
Physical Activity on Prescription, after 3 months a new prescription
Sponsors
Lund University
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Individuals between 40-65 years of age, with insufficient physical activity ( \<150 minutes of moderate-intensity physical activity throughout the week, or \< 75 minutes of vigorous-intensity physical activity throughout the week, or an equivalent combination of moderate- and vigorous-intensity activity.)
Exclusion criteria
* Dementia, severe mental disorder,newly diagnosed untreated unstable angina pectoris,myocardial infarction within 6 weeks prior to study entry. Individuals who do not master the Swedish language in speech and writing will be excluded.The patients who have abnormal values according to guidelines that require contact with a physician on the same day or week will also be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X) | Baseline ,6 months. | Each individual will wear an activity monitor for 7 days. This will be done at baseline and after 6 months. The difference in the time of physical activity level was measured in minutes of activity during a week and then divided into percentages of sedentary time, light physical activity time and moderate to vigourous physical activity time, measured by activity monitor Actigraph (GT3X). In the analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between Groups in the Amount of Self-perceived Sleep Problems | Baseline, 3 months, 6 months | Insomnia Severity Index(ISI); is a self-report questionnaire measuring insomnia symptoms to evaluate the degree of insomnia. The scale consists of seven questions that evaluate Sleep mode, sleep during the night, waking up early, the feeling of being rested, how sleeping problems affect daily life, and how sleep patterns concern the individual. The higher the score, the better the outcome. Minimun score = 0, Maximum score = 28 |
| Difference Between the Three Groups in Revised Assessment of Their Self-rated Health | base-line ,3 months, 6 months | assessment based on terms of perceived health with five alternative answers, a higher score incdicates a better outcome 1. very poor 2. poor 3. fair 4. good 5. very good |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PAP Only This group will follow the referral scheme for three months, and after this period they will leave new blood samples and answer surveys. They will get a new PAP with follow up after another 3 months.
PAP: Physical Activity on Prescription, after 3 months a new prescription | 29 |
| Mindfulness Only Mindfulness. This group will receive a group course in mindfulness during 8 weeks once a week, and with 20 minutes of daily personal training. Three and six months after inclusion they will answer a new set of surveys and fasting blood samples.
Mindfulness: Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day | 30 |
| Combination of the Two Groups Mindfulness and physical activity prescription. This group will get a combination of the two other groups. PAP will be prescribed during the first meeting and another one after 3 months. During the first 8 weeks once a week they will participate in a mindfulness training group and also preform 20 minutes of daily training. The same surveys as the other groups and fasting blood samples
Mindfulness: Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day
PAP: Physical Activity on Prescription, after 3 months a new prescription | 29 |
| Total | 88 |
Baseline characteristics
| Characteristic | PAP Only | Mindfulness Only | Combination of the Two Groups | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 30 Participants | 29 Participants | 88 Participants |
| Age, Continuous | 54 years | 53 years | 54 years | 54 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 29 Participants | 30 Participants | 29 Participants | 88 Participants |
| Sex: Female, Male Female | 22 Participants | 22 Participants | 20 Participants | 64 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 9 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 29 | 0 / 27 |
| other Total, other adverse events | 0 / 28 | 0 / 29 | 0 / 27 |
| serious Total, serious adverse events | 0 / 28 | 0 / 29 | 0 / 27 |
Outcome results
Primary
Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X)
Each individual will wear an activity monitor for 7 days. This will be done at baseline and after 6 months. The difference in the time of physical activity level was measured in minutes of activity during a week and then divided into percentages of sedentary time, light physical activity time and moderate to vigourous physical activity time, measured by activity monitor Actigraph (GT3X). In the analysis
Time frame: Baseline ,6 months.
Population: Baseline and 6 months follow-up after inclusion. Change in percentage of sedentary time and time in different intensity of physical activity per valid day and averaged over the number of valid days, activity monitor measured
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PAP Only | Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X) | Baseline:Percent of time in sedentary time | 66.2 percentage of time | Standard Deviation 6.7 |
| PAP Only | Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X) | Baseline:Percent of time in LIPA | 30.9 percentage of time | Standard Deviation 6.2 |
| PAP Only | Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X) | Baseline:Percent of time in MVPA | 2.6 percentage of time | Standard Deviation 0.18 |
| PAP Only | Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X) | 6 months:Percent of time in sedentary time | 65.0 percentage of time | Standard Deviation 6.8 |
| PAP Only | Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X) | 6 months Percent of LIPA | 32.0 percentage of time | Standard Deviation 5.8 |
| PAP Only | Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X) | 6 months: Percent of MVPA | 2.6 percentage of time | Standard Deviation 0.02 |
| Mindfulness Only | Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X) | 6 months: Percent of MVPA | 1.9 percentage of time | Standard Deviation 0.02 |
| Mindfulness Only | Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X) | Baseline:Percent of time in sedentary time | 65.5 percentage of time | Standard Deviation 9.2 |
| Mindfulness Only | Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X) | 6 months:Percent of time in sedentary time | 65.9 percentage of time | Standard Deviation 9.4 |
| Mindfulness Only | Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X) | 6 months Percent of LIPA | 31.6 percentage of time | Standard Deviation 9 |
| Mindfulness Only | Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X) | Baseline:Percent of time in LIPA | 31.7 percentage of time | Standard Deviation 8.2 |
| Mindfulness Only | Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X) | Baseline:Percent of time in MVPA | 2.3 percentage of time | Standard Deviation 0.02 |
| Combination of the Two Groups | Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X) | Baseline:Percent of time in LIPA | 30.3 percentage of time | Standard Deviation 8 |
| Combination of the Two Groups | Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X) | Baseline:Percent of time in MVPA | 2.4 percentage of time | Standard Deviation 0.02 |
| Combination of the Two Groups | Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X) | 6 months: Percent of MVPA | 2.7 percentage of time | Standard Deviation 0.02 |
| Combination of the Two Groups | Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X) | 6 months:Percent of time in sedentary time | 64.0 percentage of time | Standard Deviation 9.1 |
| Combination of the Two Groups | Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X) | Baseline:Percent of time in sedentary time | 66.7 percentage of time | Standard Deviation 8.8 |
| Combination of the Two Groups | Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X) | 6 months Percent of LIPA | 32.8 percentage of time | Standard Deviation 8.9 |
Secondary
Difference Between Groups in the Amount of Self-perceived Sleep Problems
Insomnia Severity Index(ISI); is a self-report questionnaire measuring insomnia symptoms to evaluate the degree of insomnia. The scale consists of seven questions that evaluate Sleep mode, sleep during the night, waking up early, the feeling of being rested, how sleeping problems affect daily life, and how sleep patterns concern the individual. The higher the score, the better the outcome. Minimun score = 0, Maximum score = 28
Time frame: Baseline, 3 months, 6 months
Population: decreasing numbers due to drop-out
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PAP Only | Difference Between Groups in the Amount of Self-perceived Sleep Problems | Insomnia Severity Index 3 months | 7 score on a scale |
| PAP Only | Difference Between Groups in the Amount of Self-perceived Sleep Problems | Insomnia Severity Index baseline | 8 score on a scale |
| PAP Only | Difference Between Groups in the Amount of Self-perceived Sleep Problems | Insomnia Severity Index 6 months | 6 score on a scale |
| Mindfulness Only | Difference Between Groups in the Amount of Self-perceived Sleep Problems | Insomnia Severity Index 3 months | 11 score on a scale |
| Mindfulness Only | Difference Between Groups in the Amount of Self-perceived Sleep Problems | Insomnia Severity Index baseline | 11 score on a scale |
| Mindfulness Only | Difference Between Groups in the Amount of Self-perceived Sleep Problems | Insomnia Severity Index 6 months | 13 score on a scale |
| Combination of the Two Groups | Difference Between Groups in the Amount of Self-perceived Sleep Problems | Insomnia Severity Index baseline | 10 score on a scale |
| Combination of the Two Groups | Difference Between Groups in the Amount of Self-perceived Sleep Problems | Insomnia Severity Index 6 months | 9 score on a scale |
| Combination of the Two Groups | Difference Between Groups in the Amount of Self-perceived Sleep Problems | Insomnia Severity Index 3 months | 9 score on a scale |
Secondary
Difference Between the Three Groups in Revised Assessment of Their Self-rated Health
assessment based on terms of perceived health with five alternative answers, a higher score incdicates a better outcome 1. very poor 2. poor 3. fair 4. good 5. very good
Time frame: base-line ,3 months, 6 months
Population: The number decreases during the study due to dropout, lost to follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PAP Only | Difference Between the Three Groups in Revised Assessment of Their Self-rated Health | 3 months | 3 score on a scale |
| PAP Only | Difference Between the Three Groups in Revised Assessment of Their Self-rated Health | Baseline | 3 score on a scale |
| PAP Only | Difference Between the Three Groups in Revised Assessment of Their Self-rated Health | 6 months | 4 score on a scale |
| Mindfulness Only | Difference Between the Three Groups in Revised Assessment of Their Self-rated Health | 3 months | 3 score on a scale |
| Mindfulness Only | Difference Between the Three Groups in Revised Assessment of Their Self-rated Health | Baseline | 3 score on a scale |
| Mindfulness Only | Difference Between the Three Groups in Revised Assessment of Their Self-rated Health | 6 months | 4 score on a scale |
| Combination of the Two Groups | Difference Between the Three Groups in Revised Assessment of Their Self-rated Health | Baseline | 3 score on a scale |
| Combination of the Two Groups | Difference Between the Three Groups in Revised Assessment of Their Self-rated Health | 6 months | 4 score on a scale |
| Combination of the Two Groups | Difference Between the Three Groups in Revised Assessment of Their Self-rated Health | 3 months | 4 score on a scale |