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/40414835/Actively Recruiting
Led by Columbia University · Updated on 2026-04-09
324
Participants Needed
1
Research Sites
8 weeks
Total Duration
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
Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health
K
Keith Diaz, PhD
M
Maria Serafini, BS
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Columbia University
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Sedentary Break (walking breaks during prolonged sitting) | Continuous Sitting (no breaks) |
|---|---|---|
| What it is | Within‑participant condition of frequent walking breaks (varied frequency and duration) during a prolonged sitting lab visit. | Within‑participant condition of uninterrupted sitting during a prolonged lab visit. |
| Role in trial | Experimental active condition designed to determine the effective dose of sedentary breaks. | Control condition representing continuous sedentary behavior without intervention. |
| Primary use | To identify which frequency and duration of walking breaks improve blood pressure and glucose responses during prolonged sitting. | To serve as baseline sedentary condition for comparison of cardiometabolic outcomes. |
| How it is performed | Participants remain seated during a 9‑hour lab visit and take treadmill walking breaks at predefined frequency and duration combinations. | Participants remain seated throughout a 9‑hour lab visit, only standing to use the restroom at set times. |
| Evidence status | Dose‑finding adaptive randomization is ongoing; no results yet available. | Serves as baseline condition; effectiveness in reducing cardiometabolic risk is not applicable. |
| Important risks | Not established yet; tolerability and any physical exhaustion or musculoskeletal injury are being measured in trial. | No safety claims; acts as non‑intervention baseline. |
| Important limitations | Lab‑based, acute 9‑hour visits may not represent real‑world behavior or long‑term effects. | Same limitation applies: controlled setting may limit generalizability to daily life. |
| Patient impact | Evidence suggests that breaking sitting with frequent walking can reduce post‑meal glucose and lower systolic blood pressure modestly, but long‑term patient health impact remains to be confirmed. | Continued sedentary behavior is associated with poorer cardiometabolic markers; serving as baseline comparison. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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)
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
2
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Keith M Diaz, Margaret E Murdock, Adriana Wu Clark...
https://pubmed.ncbi.nlm.nih.gov/40414835/Columbia University
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor