An interventional study of Intervention in Hypertension and Prehypertension, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
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.
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
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)
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)
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)
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)
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)
Aldosterone
Aldosterone will be measured at baseline and 3 month follow-up.
Time frame: Baseline and Follow-Up (3 months)
Glucose
Glucose will be measure at baseline and 3 month follow-up.
Time frame: Baseline and Follow-up (3 months)
Insulin
Insulin will be measured at baseline and 3 month follow-up.
Time frame: Baseline and Follow-Up (3 months)
Weight
Weight will be measured by digital scale at baseline and 3 month follow-up.
Time frame: Baseline and 3 months
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.
| Milestone | Sedentary Behavior Intervention | No Contact Control |
|---|---|---|
| Started | 136 | 135 |
| Completed | 134 | 129 |
| Not completed | 2 | 6 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Pregnancy | 0 | 2 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 2 |
Resting systolic blood pressure will be measured at baseline and follow-up using an oscillometric device after a 10-minute rest on two occasions
| mm Hg | Sedentary Behavior Intervention | No Contact Control |
|---|---|---|
| Baseline Systolic Resting Blood Pressure | 129.5 ± 8.3 | 127.9 ± 9.2 |
| Follow-Up Systolic Resting Blood Pressure | 124.3 ± 8.9 | 123.6 ± 10.9 |
Resting diastolic blood pressure will be measured at baseline and follow-up using an oscillometric device after a 10-min rest on two occasions
| mm Hg | Sedentary Behavior Intervention | No Contact Control |
|---|---|---|
| Resting Baseline Diastolic Blood Pressure | 82.7 ± 7.0 | 82.9 ± 6.4 |
| Resting Follow-Up Diastolic Blood Pressure | 79.7 ± 7.8 | 79.9 ± 6.9 |
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
| mm Hg | Sedentary Behavior Intervention | No Contact Control |
|---|---|---|
| 24-Hour Baseline Systolic Blood Pressure | 130.2 ± 8.8 | 129.5 ± 9.5 |
| 24-Hour Baseline Diastolic Blood Pressure | 78.1 ± 6.4 | 78.4 ± 6.4 |
| 24-Hour Follow-Up Systolic Blood Pressure | 130.2 ± 10.4 | 129.7 ± 9.8 |
| 24-Hour Follow-Up Diastolic Blood Pressure | 78.6 ± 7.5 | 77.9 ± 6.9 |
Carotid-femoral and carotid-radial pulse wave velocity will be measured at baseline and follow-up following a 10-min supine rest via tonometry.
| m/s | Intervention | Control |
|---|---|---|
| Baseline carotid-femoral | 8.22 ± 1.70 | 7.66 ± 1.20 |
| Baseline carotid-radial | 9.09 ± 1.30 | 8.97 ± 1.05 |
| Follow-up carotid-femoral | 8.29 ± 1.76 | 7.68 ± 1.18 |
| Follow-up carotid-radial | 9.16 ± 1.23 | 9.07 ± 1.11 |
Plasma Renin Activity (PRA) will be measured at baseline and 3 month follow-up.
| ng/mL/hr | Intervention | Control |
|---|---|---|
| Plasma Renin Activity | -0.16 ± 1.02 | 0.07 ± 0.75 |
Aldosterone will be measured at baseline and 3 month follow-up.
| ng/dL | Intervention | Control |
|---|---|---|
| Aldosterone | -0.52 ± 49.25 | 13.14 ± 45.88 |
Glucose will be measure at baseline and 3 month follow-up.
| mg/dL | Intervention | Control |
|---|---|---|
| Glucose | -2.81 ± 13.83 | 0.76 ± 12.00 |
Insulin will be measured at baseline and 3 month follow-up.
| U/mL | Intervention | Control |
|---|---|---|
| Insulin | -1.44 ± 15.39 | -0.02 ± 6.11 |
Weight will be measured by digital scale at baseline and 3 month follow-up.
| kg | Intervention | Control |
|---|---|---|
| Baseline Weight | 88.1 ± 18.9 | 90.8 ± 22.4 |
| Follow-up Weight | 87.9 ± 18.6 | 91.2 ± 21.9 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/136 (0%) | 4/136 (2.9%) | 32/136 (23.5%) |
| Control | 0/135 (0%) | 4/135 (3%) | 24/135 (17.8%) |
| Event | Intervention | Control |
|---|---|---|
| Back PainMusculoskeletal and connective tissue disorders | 2/136 | 0/135 |
| Basal Cell CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/136 | 1/135 |
| Grand Mal SeizureNervous system disorders | 0/136 | 1/135 |
| Kidney StoneRenal and urinary disorders | 0/136 | 1/135 |
| Prostate CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/136 | 1/135 |
| Hospitalization due to diabetesEndocrine disorders | 1/136 | 0/135 |
| PancreatitisGastrointestinal disorders | 1/136 | 0/135 |
| Event | Intervention | Control |
|---|---|---|
| Falls and AccidentsInjury, poisoning and procedural complications | 6/136 | 0/135 |
| Skin Irritation from Monitor WearSkin and subcutaneous tissue disorders | 2/136 | 5/135 |
| Bruising on Arm from ABPMInjury, poisoning and procedural complications | 5/136 | 2/135 |
| Arm Pain and Redness from ABPM CuffInjury, poisoning and procedural complications | 4/136 | 4/135 |
| Muscle/Tendon InjuriesInjury, poisoning and procedural complications | 4/136 | 0/135 |
| Back, Joint, Arthritis PainMusculoskeletal and connective tissue disorders | 3/136 | 2/135 |
| Petechiae from ABPM MeasurementInjury, poisoning and procedural complications | 0/136 | 2/135 |
| Vasovagal Reaction Following Blood DrawGeneral disorders | 0/136 | 2/135 |
| Planned Surgical ProceduresSurgical and medical procedures | 1/136 | 2/135 |
| Positive COVID-19 DiagnosisInfections and infestations | 2/136 | 1/135 |
| Age, Continuous(years) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 47.2 ± 11.4 | 43.2 ± 11.5 | 45.2 ± 11.45 |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 81 | 82 | 163 |
| Male | 55 | 53 | 108 |
| Ethnicity (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 4 | 10 |
| Not Hispanic or Latino | 130 | 130 | 260 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 8 | 7 | 15 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 9 | 12 | 21 |
| White | 114 | 112 | 226 |
| More than one race | 3 | 1 | 4 |
| Unknown or Not Reported | 2 | 2 | 4 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All of the deidentified individual participant data collected during the trial will be shared (including the data dictionary).
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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