Effect of Reducing Sedentary Behavior on Blood Pressure

Hypertension Clinical Trial

— RESET-BP  

Official title:

Effect of Reducing Sedentary Behavior on Blood Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03307343
• Other study ID #: STUDY19030297
• Secondary ID: R01HL134809
• Status: Completed
• Phase: N/A
• Start date: January 3, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 2-arm, 3-month randomized trial comparing a novel sedentary behavior intervention vs. control in working adults (n=300). 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.

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 300 adults (150 per group). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Prehypertension

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh Physical Activity and Weight Management Research Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight	Weight will be measured by digital scale at baseline and follow-up.	3 months
Other	Glucose	Glucose will be measured at baseline and follow-up.	3 months
Other	Insulin	Insulin will be measured at baseline and follow-up.	3 months
Other	Adverse Events	We will compare adverse events between groups in the following two ways: 1) all reported events and 2) events reported at the 3-month outcome assessment. Because the increased contact with intervention participants (vs. no-contact control) could provide greater opportunity to report adverse events occurring over the 3-month study period, these two comparisons will help clarify associations between the intervention and adverse events.	Adverse events will be measured in an ongoing fashion (as reported) and formally at the 3-month outcome assessment by blinded personnel in all participants.
Primary	Resting Systolic Blood Pressure	Resting systolic blood pressure will be measured at baseline and follow-up using an oscillometric device after a 10-min rest on two occasions	3 months
Secondary	24-hour 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.	3 months
Secondary	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.	3 months
Secondary	Plasma Renin Activity	PRA will be measured at baseline and 3-month follow-up.	3 months
Secondary	Aldosterone	Aldosterone will be measured at baseline and 3-month follow-up.	3 months
Secondary	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	3 months