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Effect of Reducing Sedentary Behavior on Blood Pressure

Effect of Reducing Sedentary Behavior on Blood Pressure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03307343
Acronym
RESET-BP
Enrollment
271
Registered
2017-10-11
Start date
2018-01-03
Completion date
2022-11-22
Last updated
2024-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Prehypertension

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

BEHAVIORALIntervention

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

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome assessors will be blinded to the participant group assignment.

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Resting Systolic Blood PressureBaseline 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

MeasureTime frameDescription
24-Hour Systolic/Diastolic Ambulatory Blood PressureBaseline 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 VelocityBaseline 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 ActivityBaseline and Follow-Up (3 months)Plasma Renin Activity (PRA) will be measured at baseline and 3 month follow-up.
AldosteroneBaseline and Follow-Up (3 months)Aldosterone will be measured at baseline and 3 month follow-up.
Resting Diastolic Blood PressureBaseline 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

MeasureTime frameDescription
WeightBaseline and 3 monthsWeight will be measured by digital scale at baseline and 3 month follow-up.
InsulinBaseline and Follow-Up (3 months)Insulin will be measured at baseline and 3 month follow-up.
GlucoseBaseline 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

ArmCount
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
Total271

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up02
Overall StudyPhysician Decision10
Overall StudyPregnancy02
Overall StudyWithdrawal by Subject12

Baseline characteristics

CharacteristicControlTotalIntervention
Age, Continuous43.2 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 Participants10 Participants6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
130 Participants260 Participants130 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
7 Participants15 Participants8 Participants
Race (NIH/OMB)
Black or African American
12 Participants21 Participants9 Participants
Race (NIH/OMB)
More than one race
1 Participants4 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants4 Participants2 Participants
Race (NIH/OMB)
White
112 Participants226 Participants114 Participants
Sex: Female, Male
Female
82 Participants163 Participants81 Participants
Sex: Female, Male
Male
53 Participants108 Participants55 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1360 / 135
other
Total, other adverse events
32 / 13624 / 135
serious
Total, serious adverse events
4 / 1364 / 135

Outcome results

Primary

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)

ArmMeasureGroupValue (MEAN)Dispersion
Sedentary Behavior InterventionResting Systolic Blood PressureBaseline Systolic Resting Blood Pressure129.5 mm HgStandard Deviation 8.3
Sedentary Behavior InterventionResting Systolic Blood PressureFollow-Up Systolic Resting Blood Pressure124.3 mm HgStandard Deviation 8.9
No Contact ControlResting Systolic Blood PressureBaseline Systolic Resting Blood Pressure127.9 mm HgStandard Deviation 9.2
No Contact ControlResting Systolic Blood PressureFollow-Up Systolic Resting Blood Pressure123.6 mm HgStandard Deviation 10.9
Secondary

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)

ArmMeasureGroupValue (MEAN)Dispersion
Sedentary Behavior Intervention24-Hour Systolic/Diastolic Ambulatory Blood Pressure24-Hour Baseline Systolic Blood Pressure130.2 mm HgStandard Deviation 8.8
Sedentary Behavior Intervention24-Hour Systolic/Diastolic Ambulatory Blood Pressure24-Hour Baseline Diastolic Blood Pressure78.1 mm HgStandard Deviation 6.4
Sedentary Behavior Intervention24-Hour Systolic/Diastolic Ambulatory Blood Pressure24-Hour Follow-Up Systolic Blood Pressure130.2 mm HgStandard Deviation 10.4
Sedentary Behavior Intervention24-Hour Systolic/Diastolic Ambulatory Blood Pressure24-Hour Follow-Up Diastolic Blood Pressure78.6 mm HgStandard Deviation 7.5
No Contact Control24-Hour Systolic/Diastolic Ambulatory Blood Pressure24-Hour Follow-Up Diastolic Blood Pressure77.9 mm HgStandard Deviation 6.9
No Contact Control24-Hour Systolic/Diastolic Ambulatory Blood Pressure24-Hour Baseline Systolic Blood Pressure129.5 mm HgStandard Deviation 9.5
No Contact Control24-Hour Systolic/Diastolic Ambulatory Blood Pressure24-Hour Follow-Up Systolic Blood Pressure129.7 mm HgStandard Deviation 9.8
No Contact Control24-Hour Systolic/Diastolic Ambulatory Blood Pressure24-Hour Baseline Diastolic Blood Pressure78.4 mm HgStandard Deviation 6.4
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Sedentary Behavior InterventionAldosterone-0.52 ng/dLStandard Deviation 49.25
No Contact ControlAldosterone13.14 ng/dLStandard Deviation 45.88
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Sedentary Behavior InterventionPlasma Renin Activity-0.16 ng/mL/hrStandard Deviation 1.02
No Contact ControlPlasma Renin Activity0.07 ng/mL/hrStandard Deviation 0.75
Secondary

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)

ArmMeasureGroupValue (MEAN)Dispersion
Sedentary Behavior InterventionPulse Wave VelocityBaseline carotid-femoral8.22 m/sStandard Deviation 1.7
Sedentary Behavior InterventionPulse Wave VelocityBaseline carotid-radial9.09 m/sStandard Deviation 1.3
Sedentary Behavior InterventionPulse Wave VelocityFollow-up carotid-femoral8.29 m/sStandard Deviation 1.76
Sedentary Behavior InterventionPulse Wave VelocityFollow-up carotid-radial9.16 m/sStandard Deviation 1.23
No Contact ControlPulse Wave VelocityFollow-up carotid-radial9.07 m/sStandard Deviation 1.11
No Contact ControlPulse Wave VelocityBaseline carotid-femoral7.66 m/sStandard Deviation 1.2
No Contact ControlPulse Wave VelocityFollow-up carotid-femoral7.68 m/sStandard Deviation 1.18
No Contact ControlPulse Wave VelocityBaseline carotid-radial8.97 m/sStandard Deviation 1.05
Secondary

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)

ArmMeasureGroupValue (MEAN)Dispersion
Sedentary Behavior InterventionResting Diastolic Blood PressureResting Baseline Diastolic Blood Pressure82.7 mm HgStandard Deviation 7
Sedentary Behavior InterventionResting Diastolic Blood PressureResting Follow-Up Diastolic Blood Pressure79.7 mm HgStandard Deviation 7.8
No Contact ControlResting Diastolic Blood PressureResting Baseline Diastolic Blood Pressure82.9 mm HgStandard Deviation 6.4
No Contact ControlResting Diastolic Blood PressureResting Follow-Up Diastolic Blood Pressure79.9 mm HgStandard Deviation 6.9
Other Pre-specified

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.

ArmMeasureValue (MEAN)Dispersion
Sedentary Behavior InterventionGlucose-2.81 mg/dLStandard Deviation 13.83
No Contact ControlGlucose0.76 mg/dLStandard Deviation 12
Other Pre-specified

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.

ArmMeasureValue (MEAN)Dispersion
Sedentary Behavior InterventionInsulin-1.44 U/mLStandard Deviation 15.39
No Contact ControlInsulin-0.02 U/mLStandard Deviation 6.11
Other Pre-specified

Weight

Weight will be measured by digital scale at baseline and 3 month follow-up.

Time frame: Baseline and 3 months

ArmMeasureGroupValue (MEAN)Dispersion
Sedentary Behavior InterventionWeightBaseline Weight88.1 kgStandard Deviation 18.9
Sedentary Behavior InterventionWeightFollow-up Weight87.9 kgStandard Deviation 18.6
No Contact ControlWeightBaseline Weight90.8 kgStandard Deviation 22.4
No Contact ControlWeightFollow-up Weight91.2 kgStandard Deviation 21.9

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026