Walking Breaks for Cardiometabolic Health

Overseen By Maria Serafini, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must not be taking: Antihypertensives, Diabetes control

Disqualifiers: CVD, Diabetes, Hypertension, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

324 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants do not take medication to control blood pressure or glucose, so you may need to stop these medications to participate.

What data supports the effectiveness of the treatment Walking Breaks for Cardiometabolic Health?

Research shows that taking breaks from sitting by walking can improve cardiometabolic health, as it helps reduce the risk factors associated with prolonged sitting, such as high blood sugar levels and poor heart health. ^{1 2 3 4 5}

Is it safe for humans to take walking breaks to interrupt prolonged sitting?

Research shows that taking walking breaks to interrupt prolonged sitting is generally safe for humans and can improve heart and metabolic health markers, such as blood pressure and insulin levels. ^{1 3 6 7 8}

How does the treatment of walking breaks differ from other treatments for cardiometabolic health?

Walking breaks are unique because they involve interrupting long periods of sitting with short, moderate-intensity walks, which can help improve cardiometabolic health markers like insulin and triglyceride levels. This approach is different from other treatments as it focuses on breaking up sedentary time rather than just increasing overall physical activity. ^{1 2 3 8 9}

Research Team

Keith Diaz, PhD

Principal Investigator

Florence Irving Assistant Professor of Behavioral Medicine, CUIMC

Ying Kuen (Ken) Cheung, PhD

Principal Investigator

Professor of Biostatistics, Department of Biostatistics, CUIMC

Eligibility Criteria

This trial is for adults who can understand English or Spanish, have no chronic conditions like heart disease or diabetes, don't take blood pressure or glucose medication, and have no musculoskeletal issues. Participants should not be allergic to common foods, follow specific diets, smoke cigarettes, or have trouble with IV access.

Inclusion Criteria

No allergies to common food allergens including wheat, eggs, milk or other dairy, gluten, fructose, peanuts or other nuts

I do not have any long-term health conditions like heart disease or diabetes.

Do not currently smoke cigarettes

Exclusion Criteria

I am unable to give my consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Condition

Participants undergo two 8-hour lab visits, one with sedentary breaks and one as a control condition, to determine the minimally effective and maximally tolerated doses of sedentary breaks.

2 lab visits (8 hours each)

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the experimental conditions.

4 weeks

Treatment Details

Interventions

• Controlled Diet
• Sedentary Break (Walking) Condition
• Sitting (Control) Condition

Trial Overview The study aims to find the smallest effective 'dose' of activity breaks needed during an 8-hour sitting period to improve heart health and blood sugar levels. It will test different frequencies (e.g., every 30 min) and durations (e.g., 1 min) of walking breaks against a control group that remains seated.

Participant Groups

Group I: Sedentary Break Condition > Control Condition Experimental Treatment 3 Interventions

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 have an IV inserted and blood will be drawn 11 times throughout the visit. Participants will also eat a controlled diet for two days prior to the lab visit.

Group II: Control Condition > Sedentary Break Condition Experimental Treatment 3 Interventions

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 have an IV inserted and blood will be drawn 11 times throughout the visit. Participants will also eat a controlled diet for two days prior to the lab visit.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

In a study involving 70 adults, regular activity breaks (walking for 1 minute and 40 seconds every 30 minutes) significantly reduced insulin and glucose levels after meals compared to prolonged sitting and continuous physical activity.

Regular activity breaks lowered insulin levels by 866.7 IU · L(-1) · 9 h(-1) and glucose levels by 18.9 mmol · L(-1) · 9 h(-1), demonstrating that interrupting sedentary behavior is more effective for managing post-meal metabolism than simply engaging in continuous physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breaking prolonged sitting reduces postprandial glycemia in healthy, normal-weight adults: a randomized crossover trial. Peddie, MC., Bone, JL., Rehrer, NJ., et al.[2023]

Interrupting sedentary behavior with light-intensity activity may positively impact blood sugar levels (glycemia) in adults, according to a meta-analysis of nine experimental studies.

Observational studies suggest that breaks in sedentary behavior are associated with lower obesity metrics, independent of total sitting time, indicating potential benefits for managing adiposity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of the relationship between breaks in sedentary behavior and cardiometabolic health. Chastin, SF., Egerton, T., Leask, C., et al.[2022]

In a study of 537 adolescents aged 10 to 14, increasing the number of breaks from sedentary behavior was linked to lower body mass index (BMI), suggesting a potential strategy for managing weight in this age group.

The association between breaks in sedentary time and BMI was consistent across genders and was not influenced by nutritional status or excessive sedentary time, indicating that simply incorporating more activity breaks could be beneficial for adolescents' health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breaks in Sedentary Time and Cardiometabolic Markers in Adolescents. Quirino, NMML., Prazeres Filho, A., Barbosa, AO., et al.[2021]

In a study of 5268 adults aged 20-85, those with the least sedentary behavior (SB) and the most moderate-to-vigorous physical activity (MVPA) had the healthiest cardiometabolic profiles, indicating that higher activity levels are crucial for better health outcomes.

The research found that while time spent in SB alone did not predict metabolic abnormalities when accounting for MVPA, lower levels of MVPA were significantly linked to increased obesity and cardiometabolic risks, highlighting the importance of physical activity over sedentary time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adiposity and insufficient MVPA predict cardiometabolic abnormalities in adults. Peterson, MD., Al Snih, S., Stoddard, J., et al.[2022]

Replacing sedentary behavior with moderate-to-vigorous physical activity (MVPA) is associated with improved cardiometabolic health in Korean adults, based on a study of 2197 participants from the Korea National Health and Nutrition Examination Survey (KNHANES) from 2014-2017.

The study found that as individuals increased their MVPA, the odds of experiencing adverse cardiometabolic health decreased, highlighting the importance of active lifestyles for maintaining health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isotemporal Substitution Analysis of Accelerometer-Derived Sedentary Behavior and Physical Activity on Cardiometabolic Health in Korean Adults: A Population-Based Cross-Sectional Study. Ma, J., Kim, H., Kim, J.[2021]

Breaking up prolonged sitting with light-intensity walking significantly lowers plasma glucose levels compared to uninterrupted sitting and standing, suggesting it may improve post-meal blood sugar responses.

The study, involving 10 non-obese adults in a crossover trial, found no significant differences in blood pressure or lipid levels between the different activity conditions, highlighting that light walking is more effective than standing for cardiometabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breaking up prolonged sitting with light-intensity walking improves postprandial glycemia, but breaking up sitting with standing does not. Bailey, DP., Locke, CD.[2022]

A systematic review of 45 studies found that taking breaks from sitting, particularly through walking, leads to significant improvements in cardiovascular parameters, especially blood pressure and vascular function.

Acute studies showed immediate benefits from sitting breaks, while chronic studies indicated sustained improvements in blood pressure, highlighting the importance of reducing sedentary behavior for heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Breaking Up Prolonged Sitting on Cardiovascular Parameters: A systematic Review. da Silva, GO., Santini, LB., Farah, BQ., et al.[2022]

In a study involving 11 sedentary Qatari females, breaking up prolonged sitting with moderate-intensity walking significantly reduced insulin and triglyceride levels, indicating a positive impact on cardiometabolic health.

The findings suggest that incorporating short walking breaks can be a culturally appropriate strategy to improve health markers in this population, although further research is needed to assess long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postprandial Insulin and Triglyceride Concentrations Are Suppressed in Response to Breaking Up Prolonged Sitting in Qatari Females. Chrismas, BCR., Taylor, L., Cherif, A., et al.[2023]

In a study of 4439 adults, those who engaged in light to moderate physical activity during breaks from sedentary time (the 'Breakers' group) showed significantly better cardiometabolic health outcomes, including lower levels of adiposity and improved insulin sensitivity, compared to those with more sedentary lifestyles.

Profiles that accumulated sedentary time in shorter bouts and included physical activity breaks ('Shortened sitters' and 'Breakers') had better health markers than 'Couch potatoes' and 'Prolonged sitters', suggesting that breaking up sedentary time with any form of activity can positively impact health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accumulation patterns of sedentary time and breaks and their association with cardiometabolic health markers in adults. Farrahi, V., Kangas, M., Kiviniemi, A., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Breaking prolonged sitting reduces postprandial glycemia in healthy, normal-weight adults: a randomized crossover trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Meta-analysis of the relationship between breaks in sedentary behavior and cardiometabolic health. [2022]

3. Brazil pubmed.ncbi.nlm.nih.gov

Breaks in Sedentary Time and Cardiometabolic Markers in Adolescents. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Adiposity and insufficient MVPA predict cardiometabolic abnormalities in adults. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Isotemporal Substitution Analysis of Accelerometer-Derived Sedentary Behavior and Physical Activity on Cardiometabolic Health in Korean Adults: A Population-Based Cross-Sectional Study. [2021]

6. Australia pubmed.ncbi.nlm.nih.gov

Breaking up prolonged sitting with light-intensity walking improves postprandial glycemia, but breaking up sitting with standing does not. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Effects of Breaking Up Prolonged Sitting on Cardiovascular Parameters: A systematic Review. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Postprandial Insulin and Triglyceride Concentrations Are Suppressed in Response to Breaking Up Prolonged Sitting in Qatari Females. [2023]

9. Denmark pubmed.ncbi.nlm.nih.gov

Accumulation patterns of sedentary time and breaks and their association with cardiometabolic health markers in adults. [2021]