Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health

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.

Conditions

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

Interventions

BEHAVIORAL

Sedentary Break (Walking) Condition

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.

BEHAVIORAL

Sitting (Control) Condition

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.

BEHAVIORAL

Controlled Diet

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Columbia University

  lead OTHER

Principal Investigators

• Keith Diaz, PhD · Florence Irving Assistant Professor of Behavioral Medicine, CUIMC

• Ying Kuen (Ken) Cheung, PhD · Professor of Biostatistics, Department of Biostatistics, CUIMC

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-06-30

Primary Completion

2028-01-31

Completion

2028-03-31

Countries

• United States

Study Locations