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Sitting Interruption and Whole-body Cardiovascular Health (SWITCH)

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Enrolling

Conditions

Sedentary Time
Sedentary Behavior

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05316571
1R01HL157187-01A1 (U.S. NIH Grant/Contract)
21-3195

Details and patient eligibility

About

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.

Full description

Sedentary behaviors (SB) are biologically distinct but understudied heart disease risk factors. National and international agencies have concluded that the level of evidence for an overall and dose-response association between SB and heart disease mortality is moderate-strong. These agencies do not provide specific recommendations for breaking-up SB, though do call on the research community to facilitate policy development by establishing biological plausibility, identifying the optimal dose for SB substitution strategies, and conducting randomized clinical trials to test the efficacy of these strategies. Accordingly, the goal of this study is to identify mechanism-informed, socioecological-based SB substitution recommendations to reduce heart disease risk. To achieve this goal, two aims will be addressed. Aim 1 will identify a feasible SB substitution strategy to prevent the negative cardiovascular responses to prolonged SB (i.e., strategies that people will actually follow). Adverse cardiovascular responses to prolonged SB will be measured using aortic arterial stiffness (AS), a noninvasive test that predicts future heart disease. To accomplish this aim, 56 middle-aged (36-55 years) participants will provide written informed consent, prior to the measurement of aortic AS and associated mechanistic responses to the following over 4 hours, in a randomized crossover manner: (i) SB with a 5-minute walk break once per hour; (ii) SB with a 15-minute standing break once per hour; (iii) SB with two breaks per hour, alternating between a 5-minute walk and a 15-minute stand; and (iv) SB with no breaks (control). These strategies were selected based on extensive prior work by the investigators, and because they are feasible, which is a key component of this study. SB reduction strategies will only decrease heart disease risk if people are willing to adhere to future SB substitution recommendations. To increase the likelihood of feasibility and long-term adherence, Aim 2 will evaluate the determinants of SB using a socioecological model. This recognizes that behavior change is likely to be limited if the physical and sociocultural environments do not support the behavior change. To accomplish Aim 2, a combined inductive-deductive qualitative approach will be used. Participants who complete Aim 1 will participate in one of 6 focus groups (6-8 participants/group). Crucially, the outcomes from this proposal will be instrumental in helping to design a subsequent clinical trial to test a mechanism-informed yet feasible SB reduction intervention, and in doing so directly support the development of SB policy.

Enrollment

56 estimated patients

Sex

All

Ages

36 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Aged between 36-55 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

Exclusion criteria

  • 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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

56 participants in 4 patient groups

One 5-Minute Walking Bout Each Hour
Active Comparator group
Description:
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.
Treatment:
Behavioral: One 5-Minute Walking Bout Each Hour
One 15-Minute Standing Bout Each Hour
Active Comparator group
Description:
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.
Treatment:
Behavioral: One 15-Minute Standing Bout Each Hour
One 5-Minute Walking Bout and One 15-Minute Standing Bout Each Hour
Active Comparator group
Description:
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.
Treatment:
Behavioral: One 5-Minute Walking Bout and One 15-Minute Standing Bout Each Hour
Uninterrupted Sitting
Active Comparator group
Description:
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.
Treatment:
Behavioral: Uninterrupted Sitting

Trial contacts and locations

1

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Central trial contact

Simon Higgins, PhD

Data sourced from clinicaltrials.gov

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