Walking Breaks for Cardiometabolic Health
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?
Is it safe for humans to take walking breaks to interrupt prolonged sitting?
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.12389
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
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for safety and effectiveness after the experimental conditions.
Treatment Details
Interventions
- Controlled Diet (Behavioural Intervention)
- Sedentary Break (Walking) Condition (Behavioural Intervention)
- Sitting (Control) Condition (Behavioural Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator