Hypertension, Prehypertension
Conditions
Keywords
sedentary behavior, light intensity physical activity, behavioral intervention, office workers, blood pressure, pulse wave velocity, randomized clinical trial
Brief summary
This is a 2-arm, 3-month randomized trial comparing a novel sedentary behavior intervention vs. control in working adults (n=271). The primary outcome is resting systolic blood pressure (SBP) at 3 months; secondary outcomes will be resting diastolic blood pressure (DBP), ambulatory blood pressure (ABP), and carotid-femoral pulse wave velocity (cfPWV). Also, best practice objective activity monitoring will be leveraged in the analysis of ABP to account for recent activity and posture and will inform adherence and dose-response relationships.We will also measure plasma renin activity and aldosterone as a potential mechanism of blood pressure reduction, and insulin and glucose as exploratory outcomes.
Detailed description
Hypertension (HTN) is the most common major risk factor for cardiovascular disease (CVD), affecting 1 in 3 American adults. Also, nearly another 1 in 3 adults has prehypertension (preHTN). Moderate-to-vigorous intensity physical activity (MVPA) is known to decrease BP. Guidelines recommend 150 min/week of MVPA performed in continuous bouts of ≥10 min (i.e., bouted MVPA). Sedentary behavior (SED), defined as sitting or reclining with low energy expenditure, has gained attention as a highly prevalent and distinct behavior from MVPA that is independently associated with higher BP, arterial stiffness, CVD, and mortality. These data, coupled with the fact that Americans spend more than half of the waking day in SED, suggest SED as a novel intervention target. Yet, despite heightened public perception of SED as a health risk, there is a dearth of randomized clinical trials demonstrating that SED reduction will lead to health benefits, including reduced BP. Decreasing SED more substantially could improve BP, but this remains unclear in the absence of larger randomized trials with effective SED interventions. Thus, to test initial efficacy, the Effect of Reducing Sedentary Behavior on Blood Pressure (RESET-BP) has the following specific aims: Specific aim 1: To evaluate the efficacy of our intervention targeting decreased sedentary behavior (SED) over 3 months. Outcomes include SBP (primary), DBP, ABP (nocturnal, daytime seated, daytime non-seated), and cfPWV. We hypothesize that the 3-month SED intervention will decrease SBP, DBP, ABP and cfPWV vs. controls Specific Aim 2: To explore whether renin-angiotensin-aldosterone (RAAS) activation (increased plasma renin activity (PRA) and aldosterone) mediates changes in BP elicited by SED reduction Specific Aim 3: To examine associations between achieved reductions in SED, increases in replacement behaviors (i.e., standing, other light-intensity physical activity (LPA), and BP reduction These aims will be evaluated with a 2-arm, 3-month randomized trial comparing a novel SED intervention vs. control in 271 adults. The study will recruit adults with untreated, elevated blood pressure (SBP 120-159 mmHg or DBP 80-99 mmHg) and desk jobs that require prolonged SED to maximize the opportunity for SED reduction. The intervention will target currently recommended levels of SED reduction for desk-based employees (2-4 hours/day with frequent postural changes) and will use a behavioral intervention including individual in-person (1/month) and phone counselling (1/month) focused on goal setting, overcoming barriers, self-monitoring, social support, and stimulus control. In addition, the intervention will include environmental modification via provision of a sit-stand desk attachment and external prompting via text messaging and a wrist-worn inactivity prompter.
Interventions
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.
Sponsors
Study design
Masking description
Outcome assessors will be blinded to the participant group assignment.
Eligibility
Inclusion criteria
1. Age 21-65 years 2. SBP 120-159 mmHg or DBP of 80-99 3. Inactive (Engages in less than 150 min/wk of moderate + 2 x vigorous intensity physical activity) 4. Currently perform deskwork for ≥ 20 hr/week at a desk compatible with the sit-stand attachment 5. Employment within an approximate 25-mile radius of the University of Pittsburgh 6. Stable employment (≥ 3 months in current job, plan to be in current job for the next 3 months) 7. Supervisor approval to join the intervention 8. Possession of a cellular phone able to receive text messages
Exclusion criteria
1. SBP ≥ 160 mmHg, DBP ≥ 100 mmHg 2. Use of antihypertensive or glucose controlling medication 3. Comorbid condition that would limit ability to reduce sedentary behavior (e.g. musculoskeletal condition, current chemotherapy) 4. History of ischemic heart disease, chronic heart failure, stroke, or chronic kidney disease 5. Unable to obtain consent from primary care provider or physician to participate 6. Current use of sit-stand/standing desk, sedentary behavior prompting device, enrollment in a weight loss or exercise study or program, recent (\< 1 year) or planned bariatric surgery 7. Currently pregnant or pregnant in that last 6 months; breastfeeding currently or in the last 3 months 8. Plans to be away from your desk for an extended period (\>1 week) during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resting Systolic Blood Pressure | Baseline and Follow-Up (3 months) | Resting systolic blood pressure will be measured at baseline and follow-up using an oscillometric device after a 10-minute rest on two occasions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24-Hour Systolic/Diastolic Ambulatory Blood Pressure | 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 |
| Pulse Wave Velocity | 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. |
| Plasma Renin Activity | Baseline and Follow-Up (3 months) | Plasma Renin Activity (PRA) will be measured at baseline and 3 month follow-up. |
| Aldosterone | Baseline and Follow-Up (3 months) | Aldosterone will be measured at baseline and 3 month follow-up. |
| Resting Diastolic Blood Pressure | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Weight | Baseline and 3 months | Weight will be measured by digital scale at baseline and 3 month follow-up. |
| Insulin | Baseline and Follow-Up (3 months) | Insulin will be measured at baseline and 3 month follow-up. |
| Glucose | Baseline and Follow-up (3 months) | Glucose will be measure at baseline and 3 month follow-up. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 136 |
| 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. | 135 |
| Total | 271 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Pregnancy | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Control | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 43.2 years STANDARD_DEVIATION 11.5 | 45.2 years STANDARD_DEVIATION 11.45 | 47.2 years STANDARD_DEVIATION 11.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 10 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 130 Participants | 260 Participants | 130 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 15 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 21 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) White | 112 Participants | 226 Participants | 114 Participants |
| Sex: Female, Male Female | 82 Participants | 163 Participants | 81 Participants |
| Sex: Female, Male Male | 53 Participants | 108 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 136 | 0 / 135 |
| other Total, other adverse events | 32 / 136 | 24 / 135 |
| serious Total, serious adverse events | 4 / 136 | 4 / 135 |
Outcome results
Resting Systolic Blood Pressure
Resting systolic blood pressure will be measured at baseline and follow-up using an oscillometric device after a 10-minute rest on two occasions
Time frame: Baseline and Follow-Up (3 months)
Population: Systolic Blood Pressure (SBP)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Behavior Intervention | Resting Systolic Blood Pressure | Baseline Systolic Resting Blood Pressure | 129.5 mm Hg | Standard Deviation 8.3 |
| Sedentary Behavior Intervention | Resting Systolic Blood Pressure | Follow-Up Systolic Resting Blood Pressure | 124.3 mm Hg | Standard Deviation 8.9 |
| No Contact Control | Resting Systolic Blood Pressure | Baseline Systolic Resting Blood Pressure | 127.9 mm Hg | Standard Deviation 9.2 |
| No Contact Control | Resting Systolic Blood Pressure | Follow-Up Systolic Resting Blood Pressure | 123.6 mm Hg | Standard Deviation 10.9 |
24-Hour Systolic/Diastolic Ambulatory Blood Pressure
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
Time frame: Baseline and Follow-Up (3 months)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Behavior Intervention | 24-Hour Systolic/Diastolic Ambulatory Blood Pressure | 24-Hour Baseline Systolic Blood Pressure | 130.2 mm Hg | Standard Deviation 8.8 |
| Sedentary Behavior Intervention | 24-Hour Systolic/Diastolic Ambulatory Blood Pressure | 24-Hour Baseline Diastolic Blood Pressure | 78.1 mm Hg | Standard Deviation 6.4 |
| Sedentary Behavior Intervention | 24-Hour Systolic/Diastolic Ambulatory Blood Pressure | 24-Hour Follow-Up Systolic Blood Pressure | 130.2 mm Hg | Standard Deviation 10.4 |
| Sedentary Behavior Intervention | 24-Hour Systolic/Diastolic Ambulatory Blood Pressure | 24-Hour Follow-Up Diastolic Blood Pressure | 78.6 mm Hg | Standard Deviation 7.5 |
| No Contact Control | 24-Hour Systolic/Diastolic Ambulatory Blood Pressure | 24-Hour Follow-Up Diastolic Blood Pressure | 77.9 mm Hg | Standard Deviation 6.9 |
| No Contact Control | 24-Hour Systolic/Diastolic Ambulatory Blood Pressure | 24-Hour Baseline Systolic Blood Pressure | 129.5 mm Hg | Standard Deviation 9.5 |
| No Contact Control | 24-Hour Systolic/Diastolic Ambulatory Blood Pressure | 24-Hour Follow-Up Systolic Blood Pressure | 129.7 mm Hg | Standard Deviation 9.8 |
| No Contact Control | 24-Hour Systolic/Diastolic Ambulatory Blood Pressure | 24-Hour Baseline Diastolic Blood Pressure | 78.4 mm Hg | Standard Deviation 6.4 |
Aldosterone
Aldosterone will be measured at baseline and 3 month follow-up.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedentary Behavior Intervention | Aldosterone | -0.52 ng/dL | Standard Deviation 49.25 |
| No Contact Control | Aldosterone | 13.14 ng/dL | Standard Deviation 45.88 |
Plasma Renin Activity
Plasma Renin Activity (PRA) will be measured at baseline and 3 month follow-up.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedentary Behavior Intervention | Plasma Renin Activity | -0.16 ng/mL/hr | Standard Deviation 1.02 |
| No Contact Control | Plasma Renin Activity | 0.07 ng/mL/hr | Standard Deviation 0.75 |
Pulse Wave Velocity
Carotid-femoral and carotid-radial pulse wave velocity will be measured at baseline and follow-up following a 10-min supine rest via tonometry.
Time frame: Baseline and Follow-Up (3 months)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Behavior Intervention | Pulse Wave Velocity | Baseline carotid-femoral | 8.22 m/s | Standard Deviation 1.7 |
| Sedentary Behavior Intervention | Pulse Wave Velocity | Baseline carotid-radial | 9.09 m/s | Standard Deviation 1.3 |
| Sedentary Behavior Intervention | Pulse Wave Velocity | Follow-up carotid-femoral | 8.29 m/s | Standard Deviation 1.76 |
| Sedentary Behavior Intervention | Pulse Wave Velocity | Follow-up carotid-radial | 9.16 m/s | Standard Deviation 1.23 |
| No Contact Control | Pulse Wave Velocity | Follow-up carotid-radial | 9.07 m/s | Standard Deviation 1.11 |
| No Contact Control | Pulse Wave Velocity | Baseline carotid-femoral | 7.66 m/s | Standard Deviation 1.2 |
| No Contact Control | Pulse Wave Velocity | Follow-up carotid-femoral | 7.68 m/s | Standard Deviation 1.18 |
| No Contact Control | Pulse Wave Velocity | Baseline carotid-radial | 8.97 m/s | Standard Deviation 1.05 |
Resting Diastolic Blood Pressure
Resting diastolic blood pressure will be measured at baseline and follow-up using an oscillometric device after a 10-min rest on two occasions
Time frame: Baseline and Follow-Up (3 months)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Behavior Intervention | Resting Diastolic Blood Pressure | Resting Baseline Diastolic Blood Pressure | 82.7 mm Hg | Standard Deviation 7 |
| Sedentary Behavior Intervention | Resting Diastolic Blood Pressure | Resting Follow-Up Diastolic Blood Pressure | 79.7 mm Hg | Standard Deviation 7.8 |
| No Contact Control | Resting Diastolic Blood Pressure | Resting Baseline Diastolic Blood Pressure | 82.9 mm Hg | Standard Deviation 6.4 |
| No Contact Control | Resting Diastolic Blood Pressure | Resting Follow-Up Diastolic Blood Pressure | 79.9 mm Hg | Standard Deviation 6.9 |
Glucose
Glucose will be measure at baseline and 3 month follow-up.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedentary Behavior Intervention | Glucose | -2.81 mg/dL | Standard Deviation 13.83 |
| No Contact Control | Glucose | 0.76 mg/dL | Standard Deviation 12 |
Insulin
Insulin will be measured at baseline and 3 month follow-up.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedentary Behavior Intervention | Insulin | -1.44 U/mL | Standard Deviation 15.39 |
| No Contact Control | Insulin | -0.02 U/mL | Standard Deviation 6.11 |
Weight
Weight will be measured by digital scale at baseline and 3 month follow-up.
Time frame: Baseline and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Behavior Intervention | Weight | Baseline Weight | 88.1 kg | Standard Deviation 18.9 |
| Sedentary Behavior Intervention | Weight | Follow-up Weight | 87.9 kg | Standard Deviation 18.6 |
| No Contact Control | Weight | Baseline Weight | 90.8 kg | Standard Deviation 22.4 |
| No Contact Control | Weight | Follow-up Weight | 91.2 kg | Standard Deviation 21.9 |