Trial Outcomes & Findings for Increased Physical Activity Through Mindfulness (NCT NCT02869854)
NCT ID: NCT02869854
Last Updated: 2025-04-16
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
88 participants
Primary outcome timeframe
Baseline ,6 months.
Results posted on
2025-04-16
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
29
|
|
Overall Study
COMPLETED
|
16
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
13
|
11
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Increased Physical Activity Through Mindfulness
Baseline characteristics by cohort
| Measure |
PAP Only
n=29 Participants
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
|
Mindfulness Only
n=30 Participants
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
|
Combination of the Two Groups
n=29 Participants
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
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
54 years
n=5 Participants
|
53 years
n=7 Participants
|
54 years
n=5 Participants
|
54 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
PAP Only
n=29 Participants
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
|
Mindfulness Only
n=30 Participants
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
|
Combination of the Two Groups
n=29 Participants
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
|
|---|---|---|---|
|
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
|
31.6 percentage of time
Standard Deviation 9.0
|
32.8 percentage of time
Standard Deviation 8.9
|
|
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
|
65.5 percentage of time
Standard Deviation 9.2
|
66.7 percentage of time
Standard Deviation 8.8
|
|
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
|
31.7 percentage of time
Standard Deviation 8.2
|
30.3 percentage of time
Standard Deviation 8.0
|
|
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
|
2.3 percentage of time
Standard Deviation 0.02
|
2.4 percentage of time
Standard Deviation 0.02
|
|
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
|
65.9 percentage of time
Standard Deviation 9.4
|
64.0 percentage of time
Standard Deviation 9.1
|
|
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
|
1.9 percentage of time
Standard Deviation 0.02
|
2.7 percentage of time
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: base-line ,3 months, 6 monthsPopulation: The number decreases during the study due to dropout, lost to follow-up.
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
Outcome measures
| Measure |
PAP Only
n=29 Participants
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
|
Mindfulness Only
n=30 Participants
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
|
Combination of the Two Groups
n=29 Participants
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
|
|---|---|---|---|
|
Difference Between the Three Groups in Revised Assessment of Their Self-rated Health
Baseline
|
3 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 2.0 to 5.0
|
3 score on a scale
Interval 2.0 to 5.0
|
|
Difference Between the Three Groups in Revised Assessment of Their Self-rated Health
3 months
|
3 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 2.0 to 5.0
|
4 score on a scale
Interval 2.0 to 5.0
|
|
Difference Between the Three Groups in Revised Assessment of Their Self-rated Health
6 months
|
4 score on a scale
Interval 1.0 to 4.0
|
4 score on a scale
Interval 2.0 to 5.0
|
4 score on a scale
Interval 2.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: decreasing numbers due to drop-out
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
Outcome measures
| Measure |
PAP Only
n=29 Participants
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
|
Mindfulness Only
n=30 Participants
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
|
Combination of the Two Groups
n=29 Participants
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
|
|---|---|---|---|
|
Difference Between Groups in the Amount of Self-perceived Sleep Problems
Insomnia Severity Index baseline
|
8 score on a scale
Interval 0.0 to 24.0
|
11 score on a scale
Interval 0.0 to 27.0
|
10 score on a scale
Interval 0.0 to 21.0
|
|
Difference Between Groups in the Amount of Self-perceived Sleep Problems
Insomnia Severity Index 3 months
|
7 score on a scale
Interval 0.0 to 20.0
|
11 score on a scale
Interval 0.0 to 27.0
|
9 score on a scale
Interval 0.0 to 27.0
|
|
Difference Between Groups in the Amount of Self-perceived Sleep Problems
Insomnia Severity Index 6 months
|
6 score on a scale
Interval 0.0 to 18.0
|
13 score on a scale
Interval 0.0 to 25.0
|
9 score on a scale
Interval 0.0 to 18.0
|
Adverse Events
PAP Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mindfulness Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Combination of the Two Groups
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place