Effect of Reducing Sedentary Behavior on Blood Pressure (RESET-BP)

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Prehypertension
• Intervention / Treatment: Behavioral: Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 271
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15216
      • University of Pittsburgh Physical Activity and Weight Management Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Other Names: Sedentary Behavior Reduction
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline and Follow-Up (3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline and Follow-Up (3 months)
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	Baseline and Follow-Up (3 months)
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.	Baseline and Follow-Up (3 months)
Plasma Renin Activity	Plasma Renin Activity (PRA) will be measured at baseline and 3 month follow-up.	Baseline and Follow-Up (3 months)
Aldosterone	Aldosterone will be measured at baseline and 3 month follow-up.	Baseline and Follow-Up (3 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose	Glucose will be measure at baseline and 3 month follow-up.	Baseline and Follow-up (3 months)
Insulin	Insulin will be measured at baseline and 3 month follow-up.	Baseline and Follow-Up (3 months)
Weight	Weight will be measured by digital scale at baseline and 3 month follow-up.	Baseline and 3 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Bethany Barone Gibbs, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Actual): November 22, 2022
• Study Completion (Actual): November 22, 2022

Study Registration Dates

• First Submitted: October 5, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: behavioral intervention; blood pressure; sedentary behavior; randomized clinical trial; pulse wave velocity; light intensity physical activity; office workers
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Prehypertension
• Other Study ID Numbers: STUDY19030297; R01HL134809 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the deidentified individual participant data collected during the trial will be shared (including the data dictionary).
• IPD Sharing Time Frame: Immediately following publication with no planned end date.
• IPD Sharing Access Criteria: Data access will be provided to researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No