Trial Outcomes & Findings for Effect of Reducing Sedentary Behavior on Blood Pressure (NCT NCT03307343)
NCT ID: NCT03307343
Last Updated: 2024-12-19
Results Overview
Resting systolic blood pressure will be measured at baseline and follow-up using an oscillometric device after a 10-minute rest on two occasions
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
271 participants
Primary outcome timeframe
Baseline and Follow-Up (3 months)
Results posted on
2024-12-19
Participant Flow
Participants were recruited from the vicinity of Pittsburgh, Pennsylvania using a variety of methods (physician's lists, research registries, university automated email blasts, etc.) between November 2017 and November 2022. The first participant was enrolled on January 3, 2018, and the last participant to complete data collection was on November 22, 2022.
271 participants met inclusion criteria and were randomized to either the Sedentary Behavior Reduction Group or the No Contact Control Group. The majority of enrolled participants were excluded due to out of range blood pressure measurements and loss of interest.
Participant milestones
| Measure |
Sedentary Behavior Intervention
The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior.
|
No Contact Control
Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment.
|
|---|---|---|
|
Overall Study
STARTED
|
136
|
135
|
|
Overall Study
COMPLETED
|
134
|
129
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
| Measure |
Sedentary Behavior Intervention
The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior.
|
No Contact Control
Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Pregnancy
|
0
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Effect of Reducing Sedentary Behavior on Blood Pressure
Baseline characteristics by cohort
| Measure |
Intervention
n=136 Participants
The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior.
Intervention: The intervention will be delivered by trained research staff who are exercise physiologists or behavioral lifestyle counselors. This target reflects a recent expert statement concluding that desk-based workers should reduce workday sedentary behavior by 2-4 hr (by increasing standing and movement). The approach will combine: behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts. Face-to-face intervention lessons occurred in months 1, 2, and 3. Telephone intervention contacts will occur in the 3rd week of months 1-3.
|
Control
n=135 Participants
Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment.
|
Total
n=271 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
45.2 years
STANDARD_DEVIATION 11.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
130 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
260 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
114 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Follow-Up (3 months)Population: Systolic Blood Pressure (SBP)
Resting systolic blood pressure will be measured at baseline and follow-up using an oscillometric device after a 10-minute rest on two occasions
Outcome measures
| Measure |
Sedentary Behavior Intervention
n=136 Participants
The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior.
|
No Contact Control
n=135 Participants
Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment.
|
|---|---|---|
|
Resting Systolic Blood Pressure
Baseline Systolic Resting Blood Pressure
|
129.5 mm Hg
Standard Deviation 8.3
|
127.9 mm Hg
Standard Deviation 9.2
|
|
Resting Systolic Blood Pressure
Follow-Up Systolic Resting Blood Pressure
|
124.3 mm Hg
Standard Deviation 8.9
|
123.6 mm Hg
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Baseline and Follow-Up (3 months)Resting diastolic blood pressure will be measured at baseline and follow-up using an oscillometric device after a 10-min rest on two occasions
Outcome measures
| Measure |
Sedentary Behavior Intervention
n=136 Participants
The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior.
|
No Contact Control
n=135 Participants
Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment.
|
|---|---|---|
|
Resting Diastolic Blood Pressure
Resting Baseline Diastolic Blood Pressure
|
82.7 mm Hg
Standard Deviation 7.0
|
82.9 mm Hg
Standard Deviation 6.4
|
|
Resting Diastolic Blood Pressure
Resting Follow-Up Diastolic Blood Pressure
|
79.7 mm Hg
Standard Deviation 7.8
|
79.9 mm Hg
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Baseline and Follow-Up (3 months)Ambulatory blood pressure will be measured at baseline and 3-month follow-up during a workday and overnight (24 hours total) at the beginning and end of the study
Outcome measures
| Measure |
Sedentary Behavior Intervention
n=136 Participants
The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior.
|
No Contact Control
n=135 Participants
Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment.
|
|---|---|---|
|
24-Hour Systolic/Diastolic Ambulatory Blood Pressure
24-Hour Baseline Diastolic Blood Pressure
|
78.1 mm Hg
Standard Deviation 6.4
|
78.4 mm Hg
Standard Deviation 6.4
|
|
24-Hour Systolic/Diastolic Ambulatory Blood Pressure
24-Hour Follow-Up Systolic Blood Pressure
|
130.2 mm Hg
Standard Deviation 10.4
|
129.7 mm Hg
Standard Deviation 9.8
|
|
24-Hour Systolic/Diastolic Ambulatory Blood Pressure
24-Hour Baseline Systolic Blood Pressure
|
130.2 mm Hg
Standard Deviation 8.8
|
129.5 mm Hg
Standard Deviation 9.5
|
|
24-Hour Systolic/Diastolic Ambulatory Blood Pressure
24-Hour Follow-Up Diastolic Blood Pressure
|
78.6 mm Hg
Standard Deviation 7.5
|
77.9 mm Hg
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Baseline and Follow-Up (3 months)Carotid-femoral and carotid-radial pulse wave velocity will be measured at baseline and follow-up following a 10-min supine rest via tonometry.
Outcome measures
| Measure |
Sedentary Behavior Intervention
n=136 Participants
The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior.
|
No Contact Control
n=135 Participants
Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment.
|
|---|---|---|
|
Pulse Wave Velocity
Follow-up carotid-radial
|
9.16 m/s
Standard Deviation 1.23
|
9.07 m/s
Standard Deviation 1.11
|
|
Pulse Wave Velocity
Baseline carotid-femoral
|
8.22 m/s
Standard Deviation 1.70
|
7.66 m/s
Standard Deviation 1.20
|
|
Pulse Wave Velocity
Baseline carotid-radial
|
9.09 m/s
Standard Deviation 1.30
|
8.97 m/s
Standard Deviation 1.05
|
|
Pulse Wave Velocity
Follow-up carotid-femoral
|
8.29 m/s
Standard Deviation 1.76
|
7.68 m/s
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: Baseline and Follow-Up (3 months)Population: Participants who had both baseline and follow-up valid blood samples were included. Change descriptive results are reported.
Plasma Renin Activity (PRA) will be measured at baseline and 3 month follow-up.
Outcome measures
| Measure |
Sedentary Behavior Intervention
n=87 Participants
The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior.
|
No Contact Control
n=85 Participants
Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment.
|
|---|---|---|
|
Plasma Renin Activity
|
-0.16 ng/mL/hr
Standard Deviation 1.02
|
0.07 ng/mL/hr
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Baseline and Follow-Up (3 months)Population: Participants who had both baseline and follow-up valid blood samples were included. Change descriptive results are reported.
Aldosterone will be measured at baseline and 3 month follow-up.
Outcome measures
| Measure |
Sedentary Behavior Intervention
n=87 Participants
The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior.
|
No Contact Control
n=86 Participants
Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment.
|
|---|---|---|
|
Aldosterone
|
-0.52 ng/dL
Standard Deviation 49.25
|
13.14 ng/dL
Standard Deviation 45.88
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Follow-up (3 months)Population: Participants who had both baseline and follow-up valid blood samples were included. Change descriptive results are reported.
Glucose will be measure at baseline and 3 month follow-up.
Outcome measures
| Measure |
Sedentary Behavior Intervention
n=95 Participants
The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior.
|
No Contact Control
n=93 Participants
Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment.
|
|---|---|---|
|
Glucose
|
-2.81 mg/dL
Standard Deviation 13.83
|
0.76 mg/dL
Standard Deviation 12.00
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Follow-Up (3 months)Population: Participants who had both baseline and follow-up valid blood samples were included. Change descriptive results are reported.
Insulin will be measured at baseline and 3 month follow-up.
Outcome measures
| Measure |
Sedentary Behavior Intervention
n=95 Participants
The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior.
|
No Contact Control
n=93 Participants
Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment.
|
|---|---|---|
|
Insulin
|
-1.44 U/mL
Standard Deviation 15.39
|
-0.02 U/mL
Standard Deviation 6.11
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 3 monthsWeight will be measured by digital scale at baseline and 3 month follow-up.
Outcome measures
| Measure |
Sedentary Behavior Intervention
n=136 Participants
The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior.
|
No Contact Control
n=135 Participants
Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment.
|
|---|---|---|
|
Weight
Baseline Weight
|
88.1 kg
Standard Deviation 18.9
|
90.8 kg
Standard Deviation 22.4
|
|
Weight
Follow-up Weight
|
87.9 kg
Standard Deviation 18.6
|
91.2 kg
Standard Deviation 21.9
|
Adverse Events
Intervention
Serious events: 4 serious events
Other events: 32 other events
Deaths: 0 deaths
Control
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=136 participants at risk
The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior.
Intervention: The intervention will be delivered by trained research staff who are exercise physiologists or behavioral lifestyle counselors. This target reflects a recent expert statement concluding that desk-based workers should reduce workday sedentary behavior by 2-4 hr (by increasing standing and movement). The approach will combine: behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts. The initial in-person session will occur at the participant's office location. During months 2 and 3, one-on-one in-person meetings will occur at the research lab. Telephone intervention contacts will occur in the 3rd week of months 1-3.
|
Control
n=135 participants at risk
Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/136 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
0.74%
1/135 • Number of events 1 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.5%
2/136 • Number of events 2 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
0.00%
0/135 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Endocrine disorders
Hospitalization due to diabetes
|
0.74%
1/136 • Number of events 1 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
0.00%
0/135 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Nervous system disorders
Grand Mal Seizure
|
0.00%
0/136 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
0.74%
1/135 • Number of events 1 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Renal and urinary disorders
Kidney Stone
|
0.00%
0/136 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
0.74%
1/135 • Number of events 1 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/136 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
0.74%
1/135 • Number of events 1 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.74%
1/136 • Number of events 1 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
0.00%
0/135 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
Other adverse events
| Measure |
Intervention
n=136 participants at risk
The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior.
Intervention: The intervention will be delivered by trained research staff who are exercise physiologists or behavioral lifestyle counselors. This target reflects a recent expert statement concluding that desk-based workers should reduce workday sedentary behavior by 2-4 hr (by increasing standing and movement). The approach will combine: behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts. The initial in-person session will occur at the participant's office location. During months 2 and 3, one-on-one in-person meetings will occur at the research lab. Telephone intervention contacts will occur in the 3rd week of months 1-3.
|
Control
n=135 participants at risk
Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Bruising on Arm from ABPM
|
3.7%
5/136 • Number of events 6 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
1.5%
2/135 • Number of events 2 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Injury, poisoning and procedural complications
Arm Pain and Redness from ABPM Cuff
|
2.9%
4/136 • Number of events 4 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
3.0%
4/135 • Number of events 5 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Injury, poisoning and procedural complications
Petechiae from ABPM Measurement
|
0.00%
0/136 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
1.5%
2/135 • Number of events 2 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation from Monitor Wear
|
1.5%
2/136 • Number of events 2 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
3.7%
5/135 • Number of events 6 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
General disorders
Vasovagal Reaction Following Blood Draw
|
0.00%
0/136 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
1.5%
2/135 • Number of events 2 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/136 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
0.74%
1/135 • Number of events 1 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Infections and infestations
Positive COVID-19 Diagnosis
|
1.5%
2/136 • Number of events 2 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
0.74%
1/135 • Number of events 1 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Injury, poisoning and procedural complications
Concussion from Object Falling on Head
|
0.00%
0/136 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
0.74%
1/135 • Number of events 1 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Metabolism and nutrition disorders
Started taking disallowed medication (Metformin)
|
0.00%
0/136 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
0.74%
1/135 • Number of events 1 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back, Joint, Arthritis Pain
|
2.2%
3/136 • Number of events 7 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
1.5%
2/135 • Number of events 6 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Psychiatric disorders
Eating Disorder
|
0.00%
0/136 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
0.74%
1/135 • Number of events 1 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Surgical and medical procedures
Planned Surgical Procedures
|
0.74%
1/136 • Number of events 1 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
1.5%
2/135 • Number of events 2 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Endocrine disorders
Diabetes Diagnosis
|
0.74%
1/136 • Number of events 1 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
0.00%
0/135 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Gastrointestinal disorders
Diverticulitis Event/Diagnosis
|
0.74%
1/136 • Number of events 1 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
0.00%
0/135 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Gastrointestinal disorders
Allergic Reaction (difficulty breathing)
|
0.74%
1/136 • Number of events 1 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
0.00%
0/135 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Injury, poisoning and procedural complications
Falls and Accidents
|
4.4%
6/136 • Number of events 8 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
0.00%
0/135 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Injury, poisoning and procedural complications
Muscle/Tendon Injuries
|
2.9%
4/136 • Number of events 7 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
0.00%
0/135 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Social circumstances
Traumatic Incident
|
0.74%
1/136 • Number of events 1 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
0.00%
0/135 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
|
Injury, poisoning and procedural complications
Tick Bite
|
0.74%
1/136 • Number of events 1 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
0.00%
0/135 • 3 months
Adverse events were assessed prospectively at each research interaction and systematically at 3-month follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place