Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT05353322
Status
Recruiting
Apply to this trial

Conditions

  • Blood Pressure
  • Cardiometabolic Risk Factors
  • Glucose
  • Sedentary Behavior

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Sedentary Break (Walking) Condition — BEHAVIORAL
    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) Condition — BEHAVIORAL
    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 Diet — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
Jun 30, 2022
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
324 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Sedentary Break Condition > Control Condition
    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.
  • Experimental: Control Condition > Sedentary Break Condition
    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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Behavioral Cardiovascular HealthNew YorkNew York10032
Maria Serafini, BS
[email protected]
347-213-0907
Keith Diaz, PhD (PRINCIPAL_INVESTIGATOR)
Daichi Shimbo, MD (SUB_INVESTIGATOR)
Henry Ginsberg, MD (SUB_INVESTIGATOR)

Find similar trials in New York, NY

By research site
Center for Behavioral Cardiovascular Health· New York, NY

Related Studies