Effect of Reducing Sedentary Behavior on Blood Pressure

NCT03307343 | Completed Results DMC

• 2 other identifiers: STUDY19030297R01HL134809
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Prehypertension

Keywords

sedentary behavior; light intensity physical activity; behavioral intervention; office workers; blood pressure; pulse wave velocity; randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Resting Diastolic Blood Pressure

  Baseline and Follow-Up (3 months)

• 24-Hour Systolic/Diastolic Ambulatory Blood Pressure

  Baseline and Follow-Up (3 months)

• Pulse Wave Velocity

  Baseline and Follow-Up (3 months)

• Plasma Renin Activity

  Baseline and Follow-Up (3 months)

• Aldosterone

  Baseline and Follow-Up (3 months)

Other Outcomes (3)

• Glucose

  Baseline and Follow-up (3 months)

• Insulin

  Baseline and Follow-Up (3 months)

• Weight

  Baseline and 3 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Intervention BEHAVIORAL

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.

Also known as: Sedentary Behavior Reduction

Intervention

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-65 years
• SBP 120-159 mmHg or DBP of 80-99
• Inactive (Engages in less than 150 min/wk of moderate + 2 x vigorous intensity physical activity)
• Currently perform deskwork for ≥ 20 hr/week at a desk compatible with the sit-stand attachment
• Employment within an approximate 25-mile radius of the University of Pittsburgh
• Stable employment (≥ 3 months in current job, plan to be in current job for the next 3 months)
• Supervisor approval to join the intervention
• Possession of a cellular phone able to receive text messages

You may not qualify if:

• SBP ≥ 160 mmHg, DBP ≥ 100 mmHg
• Use of antihypertensive or glucose controlling medication
• Comorbid condition that would limit ability to reduce sedentary behavior (e.g. musculoskeletal condition, current chemotherapy)
• History of ischemic heart disease, chronic heart failure, stroke, or chronic kidney disease
• Unable to obtain consent from primary care provider or physician to participate
• 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
• Currently pregnant or pregnant in that last 6 months; breastfeeding currently or in the last 3 months
• Plans to be away from your desk for an extended period (\>1 week) during the study period

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pittsburgh Physical Activity and Weight Management Research Center

Pittsburgh, Pennsylvania, 15216, United States

Location

Related Publications (4)

• Holmes AJ, Kline CE, Davis KK, Gordon BD, Stoner L, Quinn TD, Paley JL, Gibbs BB. Comparison of 24-Hour Movement Behaviors in Desk Workers Across Office and Work From Home Locations. J Occup Environ Med. 2025 Jul 1;67(7):e469-e477. doi: 10.1097/JOM.0000000000003380. Epub 2025 Mar 4.

  PMID: 40165467 DERIVED

• Quinn TD, Perera S, Conroy MB, Jakicic JM, Muldoon MF, Huber KA, Alansare AB, Holmes AJ, Barone Gibbs B. Impact of sedentary behaviour reduction on desk-worker workplace satisfaction, productivity, mood and health-related quality of life: a randomised trial. Occup Environ Med. 2025 Apr 16;82(2):61-68. doi: 10.1136/oemed-2024-109868.

  PMID: 40011044 DERIVED

• Barone Gibbs B, Perera S, Huber KA, Paley JL, Conroy MB, Jakicic JM, Muldoon MF. Effects of Sedentary Behavior Reduction on Blood Pressure in Desk Workers: Results From the RESET-BP Randomized Clinical Trial. Circulation. 2024 Oct 29;150(18):1416-1427. doi: 10.1161/CIRCULATIONAHA.123.068564. Epub 2024 Aug 21.

  PMID: 39166323 DERIVED

• Alansare AB, Paley JL, Quinn TD, Gibbs BB. Paradoxical Associations of Occupational and Nonoccupational Sedentary Behavior With Cardiovascular Disease Risk Measures in Desk Workers. J Occup Environ Med. 2023 Jul 1;65(7):e506-e513. doi: 10.1097/JOM.0000000000002873. Epub 2023 Apr 30.

  PMID: 37130827 DERIVED

MeSH Terms

Conditions

Hypertension; Prehypertension; Sedentary Behavior

Interventions

Methods

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Bethany Barone Gibbs
• Organization: West Virginia University

bethany.gibbs@hsc.wvu.edu

304-581-1779

Study Officials

• Bethany Barone Gibbs, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to the participant group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 11, 2017
• Study Start: January 3, 2018
• Primary Completion: November 22, 2022
• Study Completion: November 22, 2022
• Last Updated: December 19, 2024
• Results First Posted: December 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Immediately following publication with no planned end date.
• Access Criteria: Data access will be provided to researchers who provide a methodologically sound proposal.

Locations

US (1)