Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health
Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health: An Adaptive Dose-Finding Study
Columbia University
324 participants
Jun 30, 2022
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria9
- 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
- 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
Exclusion Criteria1
- • Unable to provide consent
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Interventions
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.
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.
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.
Locations(1)
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NCT05353322