Blood Pressure Clinical Trial
Official title:
Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health: An Adaptive Dose-Finding Study
The purpose of this Phase 1 research study is to answer two questions: (1) How frequent should periods of prolonged sedentary time be interrupted? and (2) What is the appropriate duration or length of time of these breaks in sedentary time? To address these questions, this project will conduct a state-of-the-art adaptive dose finding study under controlled laboratory conditions to determine the minimally effective dose (the smallest dose) that yields cardiometabolic benefit for two separate sedentary break elements (frequency and duration). Study findings will ultimately determine how often and for how long people should break up periods of prolonged sedentary time to transiently improve established cardiovascular risk factors; key foundational information critical to the success of future long-term trials and ultimately public health guidelines. Primary Aim: To determine the minimally effective dose combination(s) of frequency and duration needed to provide cardiometabolic benefit during an 8-hour experimentation period. Specifically, the study will determine: 1a. For each fixed duration, the minimum sedentary break frequency (e.g., every 30 min, 60 min, 120 min) that demonstrates a reduction in systolic BP, diastolic BP, or glucose compared with a sedentary control condition. 1b. For each fixed frequency, the minimum sedentary break duration (e.g., activity breaks of 1 min, 5 min, 10 min) that demonstrates a reduction in systolic BP, diastolic BP, or glucose compared with a sedentary control. Secondary Aim: It is also critical to public health strategy to assess the acceptability/feasibility of various sedentary break doses as too high a dose will yield poor uptake. To address this need, the maximally tolerated dose (the highest dose that does not cause undue physical/psychological distress) for frequency and duration of sedentary breaks will also be determined via assessment of 4 constructs: physical exhaustion/fatigue, affect (e.g., mood, emotion), tolerability (e.g., completion of dose protocol), and safety (e.g., hypoglycemia). Maximally tolerated dose will be defined as the highest dose where <20% of participants exhibit an adverse outcome.
Status | Recruiting |
Enrollment | 324 |
Est. completion date | March 31, 2026 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years of age or older - Ability to read, write and speak English or Spanish - No chronic medical conditions [examples include but not limited to: CVD, diabetes, high blood pressure/hypertension, chronic obstructive pulmonary disease (COPD), HIV/AIDS] - Do not take medication (over-the-counter or herbal) to control blood pressure (such as an antihypertensive medication) or glucose (such as a diabetes control medication) - Do not currently smoke cigarettes - No pre-existing musculoskeletal conditions (including but not limited to osteoarthritis, rheumatoid arthritis, psoriatic arthritis, gout, ankylosing spondylitis) that would prevent participation in intermittent physical activity - No allergies to common food allergens including wheat, eggs, milk or other dairy, gluten, fructose, peanuts or other nuts - No dietary restrictions such as vegan, gluten free, halal - Good peripheral veins with high possibility of getting IV access Exclusion Criteria: - Unable to provide consent |
Country | Name | City | State |
---|---|---|---|
United States | Center for Behavioral Cardiovascular Health | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Utrecht Work Engagement Scale (UWES-9) Score | Work Engagement - Measured by the Utrecht Work Engagement Scale (UWES-9) Score, adapted for momentary administration. The UWES-9 evaluates three dimensions of work engagement - vigor, dedication, and absorption - using a 7-point Likert scale. Higher scores reflect higher work engagement. | 4 hours, 8 hours | |
Other | Work Performance Score | Perceived work performance quantity and quality, along with an overall rating of work performance, will be measured by the World Health Organization Health and Work Performance Questionnaire (HPQ), adapted for momentary administration. The HPQ includes two items that measure performance quantity (e.g. ""How often did you not work at times when you were supposed to be working") and three items that measure performance quality on a 5-point Likert scale; along with an overall rating of work performance on a 0 to 10 scale. Higher scores reflect higher perceived work performance. | 4 hours, 8 hours | |
Primary | Change in Systolic Blood Pressure from Baseline | Measured by Spacelabs 90227 Ambulatory Blood Pressure Monitor and appropriately sized cuff on the non-dominant arm. Measured every 30 minutes over 8-hour trial visit (total of 18 individual readings). | Baseline, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 5.5 hours, 6 hours, 6.5 hours, 7 hours, 7.5 hours, 8 hours | |
Primary | Change in Diastolic Blood Pressure from Baseline | Measured by Spacelabs 90227 Ambulatory Blood Pressure Monitor and appropriately sized cuff on the non-dominant arm. Measured every 30 minutes over 8-hour trial visit (total of 18 individual readings). | Baseline, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 5.5 hours, 6 hours, 6.5 hours, 7 hours, 7.5 hours, 8 hours | |
Primary | Net Glucose Incremental Area Under the Curve | Interstitial glucose levels are measured every 15 minutes over 8-hour trial visit using the Freestyle Libre Pro Continuous Glucose Monitor inserted on deltoid of the dominant arm. | Every 15 minutes over 8-hour trial visit | |
Secondary | Proportion of participants that fully completed the sedentary break protocol. | This is to measure intervention tolerability. Tolerability is defined as full completion of the sedentary break protocol. That is, if the sedentary break dose is every 60 min for 5 min (a total of 40 min of activity over the 8 hour visit); the participant is able walk for a full 5 min every 60 min (thus walking 40 out of a possible 40 min). | Immediately after completion of experimental (activity break) trial visit (up to 8 hours) | |
Secondary | Proportion of participants with hypoglycemia | Hypoglycemia is defined as glucose levels <70 mg/dL. For each sedentary break dose, the study will calculate the proportion of participants who exhibit hypoglycemia based off serially measured blood glucose levels. | Baseline, 0.5 hour, 1 hour, 3 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 7 hours, 8 hours | |
Secondary | Proportion of participants with an exaggerated blood pressure response | An exaggerated blood pressure response is defined as systolic blood pressure =210 mm Hg for men and =190 mm Hg for women. For each sedentary break dose, the study will calculate the proportion of participants with an exaggerated blood pressure response based off of serially collected blood pressure measurements. | Baseline, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 5.5 hours, 6 hours, 6.5 hours, 7 hours, 7.5 hours, 8 hours | |
Secondary | Proportion of participants in whom a musculoskeletal injury was observed/reported. | This is to measure the prevalence of musculoskeletal Injury. Observed by research coordinator or self-reported by participant. For each sedentary break dose, the study will calculate the proportion from the collected data. | End of experimental (activity break) trial visit (up to 8 hours) | |
Secondary | Proportion of participants reporting physical exhaustion score greater than or equal to 9 | This is to measure strong feelings of fatigue/exhaustion. The Physical Exhaustion Subscale of the Exercise-Induced Feeling Inventory consists of 3 exhaustion/fatigued-related items ("Fatigued", "Tired", "Worn-out") and response options on a 5-point scale from 0 (do not feel) to 4 (feel very strongly). Responses are summed with higher scores indicating greater perceived physical exhaustion. | Baseline, 4 hours, 8 hours | |
Secondary | Proportion of participants reporting Feeling Scale Score less than 0 | This is to measure negative affective valence. The Feeling Scale is single-item questionnaire which measures pleasure/displeasure in response to physical activity. Participants are asked to rate their present feelings on an 11-point good/bad bipolar scale from -5 (very bad) to +5 (very good). | Up to 8 hours | |
Secondary | Blood Insulin Area Under the Curve | Blood samples are serially collected ten times over 8-hour trial visit by intravenous catheter. Insulin is assayed in duplicate. | Baseline, 0.5 hour, 1 hour, 3 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 7 hours, 8 hours | |
Secondary | Blood Glucose Area Under the Curve | Blood samples are serially collected ten times over 8-hour trial visit by intravenous catheter. Glucose is assayed in duplicate. | Baseline, 0.5 hour, 1 hour, 3 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 7 hours, 8 hours |
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