Effect of Reducing Sedentary Behavior on Blood Pressure

NCT ID: NCT03307343

Last Updated: 2024-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 271 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-03
• Study Completion Date: 2022-11-22

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.

Conditions

Hypertension; Prehypertension

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intervention

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Sedentary Behavior Reduction

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Bethany Barone Gibbs

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bethany Barone Gibbs, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Physical Activity and Weight Management Research Center

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40165467 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40011044 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39166323 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37130827 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01HL134809

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY19030297

Identifier Type: -

Identifier Source: org_study_id