Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
None
Trial design
Design model
Sequential
Treatments tested in this trial
Sedentary Break (Walking) Condition
BehavioralFor 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) Condition
BehavioralWhile 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 Diet
BehavioralParticipants 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.
Treatment groups
324 Participants
are divided into 2 treatment groupsGroup A: Sedentary Break Condition > Control ConditionExperimental treatment 3 interventions
Group B: Control Condition > Sedentary Break ConditionExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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).
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 hours2
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).
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 hours3
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.
Time frame
Every 15 minutes over 8-hour trial visitSecondary outcomes
1
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).
Time frame
Immediately after completion of experimental (activity break) trial visit (up to 8 hours)2
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.
Time frame
Baseline, 0.5 hour, 1 hour, 3 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 7 hours, 8 hours3
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.
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 hours4
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.
Time frame
End of experimental (activity break) trial visit (up to 8 hours)Other outcomes
1
Utrecht Work Engagement Scale (UWES-9) Score
Work Engagement - Measured by the Utrecht Work Engagement Scale (UWES-9) Score, adapted for momentary administration. The UWES-9 evaluates three dimensions of work engagement - vigor, dedication, and absorption - using a 7-point Likert scale. Higher scores reflect higher work engagement.
Time frame
4 hours, 8 hours2
Work Performance Score
Perceived work performance quantity and quality, along with an overall rating of work performance, will be measured by the World Health Organization Health and Work Performance Questionnaire (HPQ), adapted for momentary administration. The HPQ includes two items that measure performance quantity (e.g. ""How often did you not work at times when you were supposed to be working") and three items that measure performance quality on a 5-point Likert scale; along with an overall rating of work performance on a 0 to 10 scale. Higher scores reflect higher perceived work performance.
Time frame
4 hours, 8 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov