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Sedentary Behavior Interruptions for Sedentary Lifestyle (SWITCH Trial)

N/A

Recruiting

Led By Lee Stoner, PhD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Sedentary: self-reported sitting >8 hours per day

Self-reported ability to walk 4 blocks and climb 2 flights of stairs

Must not have

Morbid obesity (BMI >40 kg/m^2) or underweight (BMI <18.5 kg/m^2

Use of glucose-controlling medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measurements will be taken immediately before and after each 4-hour sb condition

Awards & highlights

No Placebo-Only Group

Summary

This trial will identify ways to reduce sedentary behavior, which has been linked to cardiovascular disease. The findings will inform a larger clinical trial testing whether sedentary behavior reduction can decrease cardiovascular disease risk.

Who is the study for?

This trial is for adults aged 36-55 who sit for over 8 hours a day, exercise less than 90 minutes per week, can walk and climb stairs without assistance, and own a cell phone. It's not for those on glucose-controlling meds, with conditions limiting movement, heavy drinkers, very high or low blood pressure patients, recent or expecting mothers, those extremely overweight or underweight, on anti-hypertensive drugs or with recent severe cardiovascular issues.

What is being tested?

The study tests how interrupting sitting time affects heart health. Participants will try different strategies: uninterrupted sitting; walking for 5 minutes each hour; standing for 15 minutes each hour; combining both walking and standing breaks every hour. The goal is to see which method works best to improve cardiovascular health.

What are the potential side effects?

Since the interventions involve basic physical activities like walking and standing there are no direct side effects associated with them. However participants may experience general discomfort from changing their usual sedentary routine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I sit for more than 8 hours a day.

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I can walk 4 blocks and climb 2 flights of stairs without help.

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I am between 36 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My BMI is either over 40 or under 18.5.

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I am taking medication to control my blood sugar.

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I use devices like canes or walkers to help me move around.

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I am planning to undergo major surgery in the next 3 months.

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I have had heart disease, heart failure, stroke, or kidney disease in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measurements will be taken immediately before and after each 4-hour sb condition

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measurements will be taken immediately before and after each 4-hour sb condition

This trial's timeline: 3 weeks for screening, Varies for treatment, and measurements will be taken immediately before and after each 4-hour sb condition for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Mean Change in Femoral-ankle PWV

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Active Control

Group I: One 15-Minute Standing Bout Each HourActive Control1 Intervention

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.

Group II: One 5-Minute Walking Bout and One 15-Minute Standing Bout Each HourActive Control1 Intervention

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.

Group III: Uninterrupted SittingActive Control1 Intervention

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.

Group IV: One 5-Minute Walking Bout Each HourActive Control1 Intervention

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.

0 / 8Eligibility criteria met