Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health
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.
Conditions:
🦠 Sedentary Behavior
🦠 Cardiometabolic Risk Factors
🦠 Blood Pressure
🦠 Glucose
🗓️ Study Start (Actual)
30 June 2022
🗓️ Primary Completion (Estimated)
30 September 2025
✅ Study Completion (Estimated)
31 March 2026
👥 Enrollment (Estimated)
324
🔬 Study Type
INTERVENTIONAL
📊 Phase
NA
Locations:
📍
New York, New York, United States
Description
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
Ages Eligible for Study:
18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Yes
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported
results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before
being posted on the public website.
Study Registration Dates
- First Submitted
7 April 2022
- First Submitted that Met QC Criteria
26 April 2022
- First Posted
29 April 2022
Study Record Updates
- Last Update Submitted that Met QC Criteria
28 August 2023
- Last Update Posted
30 August 2023
- Last Verified
August 2023