Sitting Interruption and Whole-body Cardiovascular Health

NCT05316571 | Recruiting

• 2 other identifiers: 21-31951R01HL157187-01A1
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

There is strong evidence for the association between sedentary behaviors and cardiovascular diseases such as coronary heart disease and stroke. However, the public currently has no clear guidance on how to limit or interrupt their sedentary behaviors. This study will identify and test the physiological effects of several sedentary behavior interruption strategies and explore the feasibility (i.e., likelihood of an individual performing the requested activities) of those strategies to inform the development of public policy surrounding sedentary behavior interruption. Long-term, the findings of this study will inform a large clinical trial that can test whether sedentary behavior reduction can decrease cardiovascular disease risk.

Conditions

Sedentary Behavior; Sedentary Time

Keywords

Sedentary Behavior; Interruption; Sitting; Cardiovascular; Arterial Stiffness; Pulse Wave Velocity

Outcome Measures

Primary Outcomes (1)

• Mean Change in Carotid-femoral Pulse Wave Velocity (cfPWV)

  cfPWV (m/sec) will be measured between the carotid and femoral arteries, using a collar around the neck and a cuff around the thigh, with the participant in a supine position. cfPWV is calculated by dividing path length by pulse transit time and reported as the mean of three measurements

  Measurements will be taken immediately before and after each 4-hour SB condition

Secondary Outcomes (2)

• Change in Heart-middle Cerebral Artery Pulse Wave Velocity (Brain PWV)

  Measurements will occur continuously throughout each of the 4-hour SB conditions

• Mean Change in Femoral-ankle PWV

  Measurements will be taken immediately before and after each 4-hour SB condition

Study Arms (4)

One 5-Minute Walking Bout Each Hour

ACTIVE COMPARATOR

A 4-hour sedentary behavior bout, during which the participant remains seated while watching a non-stimulatory documentary. The interruption strategy includes breaking up the 4-hour sitting bout with one 5-minute light intensity walking bout each hour. Each participant will be re-randomized to any of the non-completed arms after completion of the initial 4-hour sitting bout and interruption strategy until all arms have been completed.

Behavioral: One 5-Minute Walking Bout Each Hour

One 15-Minute Standing Bout Each Hour

ACTIVE COMPARATOR

A 4-hour sedentary behavior bout, during which the participant remains seated while watching a non-stimulatory documentary. The interruption strategy includes breaking up the 4-hour sitting bout with one 15-minute standing bout each hour. Each participant will be re-randomized to any of the non-completed arms after completion of the initial 4-hour sitting bout and interruption strategy until all arms have been completed.

Behavioral: One 15-Minute Standing Bout Each Hour

One 5-Minute Walking Bout and One 15-Minute Standing Bout Each Hour

ACTIVE COMPARATOR

A 4-hour sedentary behavior bout, during which the participant remains seated while watching a non-stimulatory documentary. The interruption strategy includes breaking up the 4-hour sitting bout with one 5-minute light intensity walking bout and one 15-minute standing bout each hour. Each participant will be re-randomized to any of the non-completed arms after completion of the initial 4-hour sitting bout and interruption strategy until all arms have been completed.

Behavioral: One 5-Minute Walking Bout and One 15-Minute Standing Bout Each Hour

Uninterrupted Sitting

ACTIVE COMPARATOR

A 4-hour sedentary behavior bout, during which the participant remains seated while watching a non-stimulatory documentary. This uninterrupted sedentary bout will serve as a control. Each participant will be re-randomized to any of the non-completed arms after completion of the initial 4-hour sitting bout and interruption strategy until all arms have been completed.

Behavioral: Uninterrupted Sitting

Interventions

One 5-Minute Walking Bout Each Hour BEHAVIORAL

One 5-minute light intensity walking break per hour throughout the 4-hour SB condition

One 5-Minute Walking Bout Each Hour

One 15-Minute Standing Bout Each Hour BEHAVIORAL

One 15-minute standing break per hour throughout the 4-hour SB condition

One 15-Minute Standing Bout Each Hour

One 5-Minute Walking Bout and One 15-Minute Standing Bout Each Hour BEHAVIORAL

Two breaks per hour throughout the 4-hour SB condition, alternating between a 5-minute light intensity walking break and a 15-minute standing break

One 5-Minute Walking Bout and One 15-Minute Standing Bout Each Hour

Uninterrupted Sitting BEHAVIORAL

No breaks will be provided throughout the 4-hour SB condition. This will be used as the control condition

Uninterrupted Sitting

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 30-60 years
• Insufficiently active: self-reported exercise \<90 minutes per week for the past 3 months
• Sedentary: self-reported sitting \>8 hours per day
• Self-reported ability to walk 4 blocks and climb 2 flights of stairs
• Possession of cellular phone able to receive text messages

You may not qualify if:

• Use of assisted-walking devices
• Comorbid condition that would limit the ability to reduce sedentary behavior (e.g., musculoskeletal condition, current chemotherapy)
• Plans for major surgery within next 3 months
• Recent history (\<1 year) of ischemic heart disease, chronic heart failure, stroke, or chronic kidney disease
• Recent (\< 1 year) or planned bariatric surgery
• Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg
• Current or recent (within last 6 months) pregnancy; current or recent (within last 3 months) breastfeeding
• Morbidly obesity (BMI \>40 kg/m\^2) or underweight (BMI \<18.5 kg/m\^2)
• Use of anti-hypertensive drugs
• Use of glucose-controlling medication
• Heavy alcohol consumption (\>15 drinks per week)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Publications (1)

• Higgins S, Cowley ES, Paterson C, Hanson ED, Dave GJ, Meyer ML, Lin FC, Gibbs BB, Vu M, Stoner L. Protocol for a study on Sitting with Interruption and Whole-Body Cardiovascular Health (SWITCH) in middle-aged adults. Contemp Clin Trials. 2023 Feb;125:107048. doi: 10.1016/j.cct.2022.107048. Epub 2022 Dec 9.

  PMID: 36509249 BACKGROUND

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Erik Hanson, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erik Hanson, PhD

CONTACT

9199620816; switchstudy@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Researchers and participants will be blinded to the condition until each day of testing, and the statistician and any technicians processing outcome data will be blinded to the condition.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will complete four, 4-hour SB bouts with the following conditions: (i) one 5-minute walk break per hour; (ii) one 15-minute standing break per hour; (iii) two breaks per hour, alternating between 5 minutes of walking and 15 minutes of standing; and (iv) SB with no breaks (control). The order of intervention will be assigned in a randomized, crossover manner with 24 potential unique sequences of intervention assignment.

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 7, 2022
• Study Start: August 15, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 9 months following publication and continuing for 36 months
• Access Criteria: Investigator has IRB, IEC, or REB approval and an executed data use/sharing agreement with UNC.

Locations

US (1)