HypertensionRESET-BPNCT03307343
Effect of Reducing Sedentary Behavior on Blood Pressure
A study testing Intervention in people with Hypertension and Prehypertension, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Hypertension, Prehypertension
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2018to 22 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Physical Activity and Weight Management Research Center
Pittsburgh, Pennsylvania, 15216
About this study
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.
Read the 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
- Being tested
- Intervention
- Keywords
- sedentary behavior, light intensity physical activity, behavioral intervention, office workers, blood pressure, pulse wave velocity, randomized clinical trial
- Medical subject headings
- Hypertension, Prehypertension, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Also called Sedentary Behavior Reduction
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and Follow-Up (3 months)
Secondary outcomes (5)
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
Measured: 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
Measured: 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.
Measured: Baseline and Follow-Up (3 months)
Plasma Renin Activity
Plasma Renin Activity (PRA) will be measured at baseline and 3 month follow-up.
Measured: Baseline and Follow-Up (3 months)
Aldosterone
Aldosterone will be measured at baseline and 3 month follow-up.
Measured: Baseline and Follow-Up (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start3 Jan 2018
- Primary completion22 Nov 2022
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Bethany Barone Gibbs, University of Pittsburgh
- Investigators
- Bethany Barone Gibbs, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307343
- Sponsor's protocol ID
- STUDY19030297
- Other IDs
- R01HL134809
- Acronym
- RESET-BP
- Status last verified
- Nov 2024
- First submitted
- 5 Oct 2017
- Last updated
- 19 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the deidentified individual participant data collected during the trial will be shared (including the data dictionary).
Publications
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.
PubMed 40165467Quinn 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.
PubMed 40011044Barone 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.
PubMed 39166323Alansare 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.
PubMed 37130827
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Reducing Sedentary Behavior on Blood Pressure
- ClinicalTrials.gov ID
- NCT03307343
- Acronym / sponsor ID
- RESET-BP / STUDY19030297
- Conditions
- Hypertension, Prehypertension
- Keywords
- sedentary behavior, light intensity physical activity, behavioral intervention, office workers, blood pressure, pulse wave velocity, randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 11 Oct 2017 (actual)
- Results
- Posted 19 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionThe 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. |
| 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionAlso: Sedentary Behavior ReductionThe 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. | Behavioural | Intervention |
Primary outcome
Resting Systolic Blood Pressure
Time frame: 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
5 secondary outcomes
Resting Diastolic Blood Pressure
Time frame: Baseline and Follow-Up (3 months)
24-Hour Systolic/Diastolic Ambulatory Blood Pressure
Time frame: Baseline and Follow-Up (3 months)
Pulse Wave Velocity
Time frame: Baseline and Follow-Up (3 months)
Plasma Renin Activity
Time frame: Baseline and Follow-Up (3 months)
Aldosterone
Time frame: Baseline and Follow-Up (3 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40165467Holmes 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.
- Derived from this study: PubMed 40011044Quinn 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.
- Derived from this study: PubMed 39166323Barone 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.
- Derived from this study: PubMed 37130827Alansare 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.
- Individual participant dataSharing planned: Yes. All of the deidentified individual participant data collected during the trial will be shared (including the data dictionary).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bethany Barone Gibbs, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Hypertension and Prehypertension, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Systolic Blood Pressure (time frame: Baseline and Follow-Up (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03307343, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.