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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 : November 9, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Bethany Barone Gibbs, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE October 5, 2017
First Posted Date  ICMJE October 11, 2017
Last Update Posted Date November 9, 2020
Actual Study Start Date  ICMJE January 3, 2018
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 20, 2017)
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: October 10, 2017)
  • Weight [ Time Frame: 3 months ]
    Weight will be measured by digital scale at baseline and follow-up.
  • Submaximal Cardiorespiratory Fitness [ Time Frame: 3 months ]
    A submaximal treadmill test will be conducted 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.
 
Descriptive Information
Brief Title  ICMJE Effect of Reducing Sedentary Behavior on Blood Pressure
Official Title  ICMJE Effect of Reducing Sedentary Behavior on Blood Pressure
Brief 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.
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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Outcome assessors will be blinded to the participant group assignment.
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Prehypertension
Intervention  ICMJE 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.
Other Name: Sedentary Behavior Reduction
Study Arms  ICMJE
  • Experimental: Intervention
    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.
    Intervention: Behavioral: Intervention
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 10, 2017)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kimberly Huber, MPH (412) 383-4750 resetbp@pitt.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03307343
Other Study ID Numbers  ICMJE R01HL134809( U.S. NIH Grant/Contract )
R01HL134809 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All of the deidentified individual participant data collected during the trial will be shared (including the data dictionary).
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Immediately following publication with no planned end date.
Access Criteria: Data access will be provided to researchers who provide a methodologically sound proposal.
Responsible Party Bethany Barone Gibbs, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Bethany Barone Gibbs, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP