Ignite Creation Date:
2024-05-06 @ 10:37 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03307343
Status:
COMPLETED
Last Update Posted:
2023-07-06
First Post:
2017-10-05
Brief Title:
Effect of Reducing Sedentary Behavior on Blood Pressure
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Effect of Reducing Sedentary Behavior on Blood Pressure
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESET-BP
Brief Summary:
This is a 2-arm 3-month randomized trial comparing a novel sedentary behavior intervention vs control in working adults n300 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 relationshipsWe 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 minweek of MVPA performed in continuous bouts of 10 min ie 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 ie 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 hoursday with frequent postural changes and will use a behavioral intervention including individual in-person 1month and phone counselling 1month 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
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 ie 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 hoursday with frequent postural changes and will use a behavioral intervention including individual in-person 1month and phone counselling 1month 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL134809 | NIH | None | httpsreporternihgovquickSearchR01HL134809 |