Breaking up prolonged sedentary behavior to improve cardiometabolic health (BREAK2): protocol for a dose-finding adaptive randomization trial.
Keith M Diaz, Margaret E Murdock, Adriana Wu Clark...
https://pubmed.ncbi.nlm.nih.gov/40414835Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05353322
Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health: An Adaptive Dose-Finding Study
Led by Columbia University · Updated on 2026-04-09
324
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how often and for how long people should interrupt prolonged periods of sitting to improve heart and metabolic health. This Phase 1 study aims to find the smallest effective combination of break frequency and duration that can lower blood pressure and glucose levels. The trial also seeks to identify the highest tolerable break levels without causing physical or emotional distress, helping guide future public health recommendations. Participants will complete two 9-hour lab visits where they either remain seated continuously or take walking breaks on a treadmill at different frequencies and durations. The walking speeds are fixed, and breaks vary from every 30 to 120 minutes and last between 1 and 10 minutes. All participants will follow a controlled diet for two days before and during the visits. The study uses an adaptive randomization method to test 25 different break patterns efficiently. During each visit, participants wear heart rate and blood pressure monitors while researchers measure blood pressure and glucose at multiple times. They will also assess how well participants tolerate the breaks by checking fatigue, mood, safety, and ability to complete the protocol. The study involves 324 adults who will each experience both conditions in randomized order. The findings will help determine effective and acceptable sedentary break guidelines for cardiovascular health.
CONDITIONS
Brief Title
Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Ability to read, write, and speak English or Spanish
- Limited or no chronic medical conditions (such as cardiovascular disease, diabetes, COPD, HIV/AIDS; controlled hypertension or high cholesterol on medication allowed)
- Not taking medications to control glucose (like diabetes medications)
- Not currently pregnant
- Do not currently smoke cigarettes
- No musculoskeletal conditions preventing intermittent physical activity
- No allergies to common food allergens (wheat, eggs, milk, gluten, fructose, peanuts, nuts)
- No dietary restrictions such as vegan, gluten-free, or halal
You will not qualify if you...
- Unable to provide consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Controlled Diet Preparation
Duration - 2 days before each lab visit
Participants follow a controlled diet for two full days before each lab visit to standardize nutritional intake.
No visits, dietary compliance at home
Trial Condition Visits
Duration - Two separate 9-hour visits
Participants complete two 9-hour lab visits in randomized order involving either the sedentary break condition or the uninterrupted sitting control condition. During visits, participants remain seated with scheduled walking breaks in the sedentary break condition and consume controlled meals.
2 visits (in-person)
Trial Site Locations
Total: 1 location
1
Center for Behavioral Cardiovascular Health
New York, New York, United States, 10032
Actively Recruiting
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Research Team
K
Keith Diaz, PhD
M
Maria Serafini, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
2
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