Sedentary BehaviorNCT05353322
Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health
A study testing Sedentary Break (Walking) Condition in people with Sedentary Behavior and Cardiometabolic Risk Factors, run by Columbia University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Cardiometabolic Risk Factors, Blood Pressure
- What is being tested?
- Sedentary Break (Walking) Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2022to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Ability to read, write and speak English or Spanish
- Limited or no chronic medical conditions [examples include but not limited to: CVD, diabetes, chronic obstructive pulmonary disease (COPD), HIV/AIDS; participants with high blood pressure/hypertension and/or high cholesterol/hyperlipidemia may be included if they are currently prescribed and taking medication for these conditions]
- Do not take medication (over-the-counter or herbal) to control glucose (such as a diabetes control medication)
- Not currently pregnant
- Do not currently smoke cigarettes
Show all 9Show fewer
- 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
Who cannot join
- Unable to provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center for Behavioral Cardiovascular Health
New York, New York, 10032
Maria Serafini, BS, 347-213-0907, cbch_break2study@cumc.columbia.edu
Keith Diaz, PhD
About this study
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:
Read more
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.
Read the detailed description
Excessive sedentary behavior is highly prevalent in developed nations and is a risk factor for cardiovascular disease (CVD) morbidity and mortality. Evidence suggests sedentary behavior is not simply a form of inactivity that elicits positive energy balance. Instead sedentary behavior itself may be harmful. As such, health agencies have provided general recommendations to "sit less, move more" by interspersing brief periods of activity. However, a lack of empirical evidence describing how often (e.g. every 30 min, every 60 min) and for how long (e.g. 1 min activity bouts, 5 min activity bouts) sedentary time should be interrupted (a "sedentary break") to yield health benefit has precluded more quantitative, actionable guidelines. To date, rigorous and methodical dose escalation experiments have not been conducted to elucidate efficacious and tolerated sedentary break doses. Without specific targets to provide to the public; public health initiatives targeting sedentary behavior will likely have minimal effectiveness. Critically, without rigorously tested dosing information; randomized controlled trials targeting sedentary behavior may be fruitless; bearing risk of inefficacious or intolerable doses. The objective of the proposed study is to determine the minimally effective dose (e.g. the smallest dose) for two elements of a sedentary break, frequency and duration, that yields improvements in established CVD risk factors. The investigator will also determine the maximally tolerated dose (e.g. the highest dose that does not cause undue physical/psychological distress) for both frequency and duration of sedentary breaks. To address the aims, the investigator will conduct a state-of-the-art dose finding study under well controlled laboratory conditions using an innovative Bayesian adaptive randomization method for dose determination never before applied to behavioral trials. This method will enable us to efficiently test 25 possible frequency/duration combinations in just a single study. The study will recruit 324 adults to complete a total of 2 trial conditions in the laboratory (8 hours each), namely a sedentary break (active) condition and an uninterrupted sitting (control) condition, in a randomized order. The sedentary break condition will consist of 1 of 25 possible frequency/duration combinations (e.g. every 30 min for 10 min), selected according to the adaptive randomization protocol. Established CVD risk factors, including blood pressure and glucose, as well as measures of dose tolerability (physical exhaustion/fatigue, affect) and work engagement and performance will be serially assessed during each trial.
This project is a groundbreaking step towards developing evidence-based guidelines for sedentary behavior that will establish a foundation upon which a successful sedentary behavior intervention development process can be rooted. By identifying the minimally effective and maximally tolerated dose combinations for the frequency and duration of a sedentary break; this Phase I/II study will provide key foundational evidence critical to the success of future Phase III and Phase IV randomized trials and ultimately public health guidelines.
- Being tested
- Sedentary Break (Walking) Condition, Sitting (Control) Condition, Controlled Diet
- Keywords
- Sedentary Behavior, Physical Activity, Blood Pressure, Glucose, Insulin, Dose-finding
- Medical subject headings
- Sedentary Behavior, Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedentary Break (Walking) ConditionBehavioural
Also called Sedentary Break (Walking) Condition - Experimental
For the sedentary break (walking) condition, participants will be randomized to 1 of 25 combinations of frequency (5 doses: sedentary break every 30, 45, 60, 90, or 120 minutes) and duration (5 doses: sedentary break duration of 1, 3, 5, 7, or 10 minutes). Participants will complete a 9-hour study visit and will remain seated throughout the lab visit and will take regular sedentary breaks by walking on a treadmill at 2.0 mph and 0% incline at specific frequency and duration (as determined by the randomization method) for the entirety of the visit.
Sitting (Control) ConditionBehavioural
Also called Sitting (Control) Condition - Shame Comparator
While completing the sitting (control) condition, participants will complete the 9-hour study visit by remaining seated and only standing up/walking to use the restroom at specified times.
Controlled DietBehavioural
Also called Controlled Foods Diet
Participants in both the experimental and control groups will eat a controlled diet (breakfast, lunch, dinner, snacks) for two full days before each lab visit. They will also eat a controlled diet (breakfast, lunch) during each of the two lab visits. Participants will choose 1 of 3 dietary menus to eat for the study duration. Each meal will be individualized to meet 33% of daily estimated energy requirements. Target macronutrient profile will be 12-15% energy from protein, 55-58% from carbohydrate and 29-31% from fat; as well as 55 mmol of sodium and 24 mmol of potassium.
| Study group | Role | What they receive |
|---|---|---|
| Sedentary Break Condition > Control Condition | Experimental | Participants will be assigned to the sedentary break or control condition at each lab visit. If assigned to the sedentary break condition at lab visit 1, participants will be assigned to the control condition at visit 2 (and vice versa). During the lab visit, participants will wear a heart rate monitor and ambulatory blood pressure monitor, and eat a controlled diet. Participants will also eat a controlled diet for two days prior to the lab visit. Receives: Behavioral: Sedentary Break (Walking) Condition; Behavioral: Sitting (Control) Condition; Behavioral: Controlled Diet |
| Control Condition > Sedentary Break Condition | Experimental | Participants will be assigned to the sedentary break or control condition at each lab visit. If assigned to the sedentary break condition at lab visit 1, participants will be assigned to the control condition at visit 2 (and vice versa). During the lab visit, participants will wear a heart rate monitor and ambulatory blood pressure monitor, and eat a controlled diet. Participants will also eat a controlled diet for two days prior to the lab visit. Receives: Behavioral: Sedentary Break (Walking) Condition; Behavioral: Sitting (Control) Condition; Behavioral: Controlled Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: 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
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.
Measured: Every 15 minutes over 8-hour trial visit
Secondary outcomes (8)
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).
Measured: Immediately after completion of experimental (activity break) trial visit (up to 8 hours)
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.
Measured: Baseline, 0.5 hour, 1 hour, 3 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 7 hours, 8 hours
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.
Measured: 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
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.
Measured: End of experimental (activity break) trial visit (up to 8 hours)
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.
Measured: Baseline, 4 hours, 8 hours
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).
Measured: Up to 8 hours
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.
Measured: Baseline, 0.5 hour, 1 hour, 3 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 7 hours, 8 hours
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.
Measured: Baseline, 0.5 hour, 1 hour, 3 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 7 hours, 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start30 Jun 2022
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Keith Diaz, Columbia University
- Investigators
- Keith Diaz, PhD, Principal investigator, Florence Irving Assistant Professor of Behavioral Medicine, CUIMCYing Kuen (Ken) Cheung, PhD, Study chair, Professor of Biostatistics, Department of Biostatistics, CUIMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353322
- Sponsor's protocol ID
- AAAT9416
- Other IDs
- 1R01HL153642-01A1
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2022
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Diaz KM, Murdock ME, Clark AW, Kumar S, Jerez V, Serafini MA, Xu C, Boudreaux BD, Romero EK, Aguirre J, Seid H, Nandakumar R, Ginsberg H, Shimbo D, Cheung YK. Breaking up prolonged sedentary behavior to improve cardiometabolic health (BREAK2): protocol for a dose-finding adaptive randomization trial. BMC Public Health. 2025 May 25;25(1):1929. doi: 10.1186/s12889-025-22250-0.
PubMed 40414835
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health: An Adaptive Dose-Finding Study
- ClinicalTrials.gov ID
- NCT05353322
- Acronym / sponsor ID
- AAAT9416
- Keywords
- Sedentary Behavior, Physical Activity, Blood Pressure, Glucose, Insulin, Dose-finding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Excessive sedentary behavior is highly prevalent in developed nations and is a risk factor for cardiovascular disease (CVD) morbidity and mortality. Evidence suggests sedentary behavior is not simply a form of inactivity that elicits positive energy balance. Instead sedentary behavior itself may be harmful. As such, health agencies have provided general recommendations to "sit less, move more" by interspersing brief periods of activity. However, a lack of empirical evidence describing how often (e.g. every 30 min, every 60 min) and for how long (e.g. 1 min activity bouts, 5 min activity bouts) sedentary time should be interrupted (a "sedentary break") to yield health benefit has precluded more quantitative, actionable guidelines. To date, rigorous and methodical dose escalation experiments have not been conducted to elucidate efficacious and tolerated sedentary break doses. Without specific targets to provide to the public; public health initiatives targeting sedentary behavior will likely have minimal effectiveness. Critically, without rigorously tested dosing information; randomized controlled trials targeting sedentary behavior may be fruitless; bearing risk of inefficacious or intolerable doses. The objective of the proposed study is to determine the minimally effective dose (e.g. the smallest dose) for two elements of a sedentary break, frequency and duration, that yields improvements in established CVD risk factors. The investigator will also determine the maximally tolerated dose (e.g. the highest dose that does not cause undue physical/psychological distress) for both frequency and duration of sedentary breaks. To address the aims, the investigator will conduct a state-of-the-art dose finding study under well controlled laboratory conditions using an innovative Bayesian adaptive randomization method for dose determination never before applied to behavioral trials. This method will enable us to efficiently test 25 possible frequency/duration combinations in just a single study. The study will recruit 324 adults to complete a total of 2 trial conditions in the laboratory (8 hours each), namely a sedentary break (active) condition and an uninterrupted sitting (control) condition, in a randomized order. The sedentary break condition will consist of 1 of 25 possible frequency/duration combinations (e.g. every 30 min for 10 min), selected according to the adaptive randomization protocol. Established CVD risk factors, including blood pressure and glucose, as well as measures of dose tolerability (physical exhaustion/fatigue, affect) and work engagement and performance will be serially assessed during each trial.
This project is a groundbreaking step towards developing evidence-based guidelines for sedentary behavior that will establish a foundation upon which a successful sedentary behavior intervention development process can be rooted. By identifying the minimally effective and maximally tolerated dose combinations for the frequency and duration of a sedentary break; this Phase I/II study will provide key foundational evidence critical to the success of future Phase III and Phase IV randomized trials and ultimately public health guidelines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedentary Break Condition > Control Condition | Experimental | Behavioral: Sedentary Break (Walking) Condition, Behavioral: Sitting (Control) Condition, Behavioral: Controlled DietParticipants will be assigned to the sedentary break or control condition at each lab visit. If assigned to the sedentary break condition at lab visit 1, participants will be assigned to the control condition at visit 2 (and vice versa). During the lab visit, participants will wear a heart rate monitor and ambulatory blood pressure monitor, and eat a controlled diet. Participants will also eat a controlled diet for two days prior to the lab visit. |
| Control Condition > Sedentary Break Condition | Experimental | Behavioral: Sedentary Break (Walking) Condition, Behavioral: Sitting (Control) Condition, Behavioral: Controlled DietParticipants will be assigned to the sedentary break or control condition at each lab visit. If assigned to the sedentary break condition at lab visit 1, participants will be assigned to the control condition at visit 2 (and vice versa). During the lab visit, participants will wear a heart rate monitor and ambulatory blood pressure monitor, and eat a controlled diet. Participants will also eat a controlled diet for two days prior to the lab visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years of age or older
- Ability to read, write and speak English or Spanish
- Limited or no chronic medical conditions [examples include but not limited to: CVD, diabetes, chronic obstructive pulmonary disease (COPD), HIV/AIDS; participants with high blood pressure/hypertension and/or high cholesterol/hyperlipidemia may be included if they are currently prescribed and taking medication for these conditions]
- Do not take medication (over-the-counter or herbal) to control glucose (such as a diabetes control medication)
- Not currently pregnant
Key exclusion criteria (1 listed)
- Unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedentary Break (Walking) ConditionAlso: Sedentary Break (Walking) Condition - ExperimentalFor the sedentary break (walking) condition, participants will be randomized to 1 of 25 combinations of frequency (5 doses: sedentary break every 30, 45, 60, 90, or 120 minutes) and duration (5 doses: sedentary break duration of 1, 3, 5, 7, or 10 minutes). Participants will complete a 9-hour study visit and will remain seated throughout the lab visit and will take regular sedentary breaks by walking on a treadmill at 2.0 mph and 0% incline at specific frequency and duration (as determined by the randomization method) for the entirety of the visit. | Behavioural | Control Condition > Sedentary Break Condition, Sedentary Break Condition > Control Condition |
| Sitting (Control) ConditionAlso: Sitting (Control) Condition - Shame ComparatorWhile completing the sitting (control) condition, participants will complete the 9-hour study visit by remaining seated and only standing up/walking to use the restroom at specified times. | Behavioural | Control Condition > Sedentary Break Condition, Sedentary Break Condition > Control Condition |
| Controlled DietAlso: Controlled Foods DietParticipants in both the experimental and control groups will eat a controlled diet (breakfast, lunch, dinner, snacks) for two full days before each lab visit. They will also eat a controlled diet (breakfast, lunch) during each of the two lab visits. Participants will choose 1 of 3 dietary menus to eat for the study duration. Each meal will be individualized to meet 33% of daily estimated energy requirements. Target macronutrient profile will be 12-15% energy from protein, 55-58% from carbohydrate and 29-31% from fat; as well as 55 mmol of sodium and 24 mmol of potassium. | Behavioural | Control Condition > Sedentary Break Condition, Sedentary Break Condition > Control Condition |
Primary outcome
Change in Systolic Blood Pressure from Baseline
Time frame: 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
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).
Change in Diastolic Blood Pressure from Baseline
Time frame: 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
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).
Net Glucose Incremental Area Under the Curve
Time frame: Every 15 minutes over 8-hour trial visit
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.
8 secondary outcomes
Proportion of participants that fully completed the sedentary break protocol.
Time frame: Immediately after completion of experimental (activity break) trial visit (up to 8 hours)
Proportion of participants with hypoglycemia
Time frame: Baseline, 0.5 hour, 1 hour, 3 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 7 hours, 8 hours
Proportion of participants with an exaggerated blood pressure response
Time frame: 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
Proportion of participants in whom a musculoskeletal injury was observed/reported.
Time frame: End of experimental (activity break) trial visit (up to 8 hours)
Proportion of participants reporting physical exhaustion score greater than or equal to 9
Time frame: Baseline, 4 hours, 8 hours
Proportion of participants reporting Feeling Scale Score less than 0
Time frame: Up to 8 hours
Blood Insulin Area Under the Curve
Time frame: Baseline, 0.5 hour, 1 hour, 3 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 7 hours, 8 hours
Blood Glucose Area Under the Curve
Time frame: Baseline, 0.5 hour, 1 hour, 3 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 7 hours, 8 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Derived from this study: PubMed 40414835Diaz KM, Murdock ME, Clark AW, Kumar S, Jerez V, Serafini MA, Xu C, Boudreaux BD, Romero EK, Aguirre J, Seid H, Nandakumar R, Ginsberg H, Shimbo D, Cheung YK. Breaking up prolonged sedentary behavior to improve cardiometabolic health (BREAK2): protocol for a dose-finding adaptive randomization trial. BMC Public Health. 2025 May 25;25(1):1929. doi: 10.1186/s12889-025-22250-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Keith Diaz, PhD principal investigator
Florence Irving Assistant Professor of Behavioral Medicine, CUIMC
Ying Kuen (Ken) Cheung, PhD study chair
Professor of Biostatistics, Department of Biostatistics, CUIMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedentary Break (Walking) Condition in people with Sedentary Behavior and Cardiometabolic Risk Factors, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keith Diaz, PhD (212-305-1170, kd2442@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic Blood Pressure from Baseline (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05353322, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.