Effect of Reducing Sedentary Behavior on Blood Pressure (RESET-BP)
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|ClinicalTrials.gov Identifier: NCT03307343|
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : January 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Prehypertension||Behavioral: Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Outcome assessors will be blinded to the participant group assignment.|
|Official Title:||Effect of Reducing Sedentary Behavior on Blood Pressure|
|Actual Study Start Date :||January 3, 2018|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
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.
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 Name: Sedentary Behavior Reduction
No Intervention: 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.
- Resting Systolic Blood Pressure [ Time Frame: 3 months ]Resting systolic blood pressure will be measured at baseline and follow-up using an oscillometric device after a 10-min rest on two occasions
- 24-hour Ambulatory Blood Pressure [ Time Frame: 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.
- Pulse Wave Velocity [ Time Frame: 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.
- Plasma Renin Activity [ Time Frame: 3 months ]PRA will be measured at baseline and 3-month follow-up.
- Aldosterone [ Time Frame: 3 months ]Aldosterone will be measured at baseline and 3-month follow-up.
- Diastolic Blood Pressure [ Time Frame: 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
- Weight [ Time Frame: 3 months ]Weight will be measured by digital scale at baseline and follow-up.
- Glucose [ Time Frame: 3 months ]Glucose will be measured at baseline and follow-up.
- Insulin [ Time Frame: 3 months ]Insulin will be measured at baseline and follow-up.
- Adverse Events [ Time Frame: 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. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307343
|Contact: Bethany Barone Gibbs, PhD||(412) firstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pittsburgh Physical Activity and Weight Management Research Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15216|
|Contact: Diane Casille 412-310-4020|
|Principal Investigator: Bethany Barone Gibbs, PhD|
|Sub-Investigator: John M Jakicic, PhD|
|Sub-Investigator: Subashan Perera, PhD|
|Sub-Investigator: Matthew Muldoon, MD|
|Sub-Investigator: Margaret B Conroy, MD|
|Principal Investigator:||Bethany Barone Gibbs||University of Pittsburgh|