University of Pittsburgh Physical Activity and Weight Management Research Center
Pittsburgh, Pennsylvania, 15216, United States
NCT Number: NCT03307343
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.
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Notify Me21 year–65 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15216, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Sedentary Behavior Reduction
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
Time frame: Baseline and Follow-Up (3 months)
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)
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)
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 (PRA) will be measured at baseline and 3 month follow-up.
Time frame: Baseline and Follow-Up (3 months)
Aldosterone will be measured at baseline and 3 month follow-up.
Time frame: Baseline and Follow-up (3 months)
Glucose will be measure at baseline and 3 month follow-up.
Time frame: Baseline and Follow-Up (3 months)
Insulin will be measured at baseline and 3 month follow-up.
Time frame: Baseline and 3 months
Weight will be measured by digital scale at baseline and 3 month follow-up.
University of Pittsburgh
Other
Acronym: RESET-BP
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