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Walking Breaks for Cardiometabolic Health

N/A

Recruiting

Led By Keith Diaz, PhD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

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

Must have

No chronic medical conditions (examples include but not limited to: CVD, diabetes, high blood pressure/hypertension, chronic obstructive pulmonary disease (COPD), HIV/AIDS)

Ability to read, write and speak English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

Study Summary

This trial will study what the best dose of sedentary breaks is to improve cardiovascular risk factors.

Who is the study for?

This trial is for adults who can understand English or Spanish, have no chronic conditions like heart disease or diabetes, don't take blood pressure or glucose medication, and have no musculoskeletal issues. Participants should not be allergic to common foods, follow specific diets, smoke cigarettes, or have trouble with IV access.Check my eligibility

What is being tested?

The study aims to find the smallest effective 'dose' of activity breaks needed during an 8-hour sitting period to improve heart health and blood sugar levels. It will test different frequencies (e.g., every 30 min) and durations (e.g., 1 min) of walking breaks against a control group that remains seated.See study design

What are the potential side effects?

Potential side effects from participating in this trial may include physical fatigue from the walking activities and psychological distress due to frequent interruptions of sedentary time. Safety measures will monitor for any undue stress or hypoglycemia.

Eligibility Criteria

Inclusion Criteria

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

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I do not have any long-term health conditions like heart disease or diabetes.

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I can read, write, and speak in English or Spanish.

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I am 18 years old or older.

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I do not take medication for blood pressure or diabetes.

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I don't have joint or muscle conditions that stop me from doing some physical activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Diastolic Blood Pressure from Baseline

Change in Systolic Blood Pressure from Baseline

Net Glucose Incremental Area Under the Curve

Secondary outcome measures

Blood Glucose Area Under the Curve

Blood Insulin Area Under the Curve

Proportion of participants in whom a musculoskeletal injury was observed/reported.

+5 more

Other outcome measures

Utrecht Work Engagement Scale (UWES-9) Score

Work Performance Score

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sedentary Break Condition > Control ConditionExperimental Treatment3 Interventions

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 have an IV inserted and blood will be drawn 11 times throughout the visit. Participants will also eat a controlled diet for two days prior to the lab visit.

Group II: Control Condition > Sedentary Break ConditionExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Controlled Diet

2020

N/A

~70

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,460,691 Total Patients Enrolled

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

3,837 Previous Clinical Trials

47,851,303 Total Patients Enrolled

Keith Diaz, PhDPrincipal InvestigatorFlorence Irving Assistant Professor of Behavioral Medicine, CUIMC

Media Library

Sedentary Break (Walking) Condition Clinical Trial Eligibility Overview. Trial Name: NCT05353322 — N/A

Cardiometabolic Risk Factors Research Study Groups: Sedentary Break Condition > Control Condition, Control Condition > Sedentary Break Condition

Cardiometabolic Risk Factors Clinical Trial 2023: Sedentary Break (Walking) Condition Highlights & Side Effects. Trial Name: NCT05353322 — N/A

Sedentary Break (Walking) Condition 2023 Treatment Timeline for Medical Study. Trial Name: NCT05353322 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate size of the population being observed for this experiment?

"Affirmative. Clinicaltrials.gov shows that this investigation has commenced patient recruitment, which began on June 30th 2022 and was last modified on July 7th 2022. This examination necessitates the enrolment of 324 patients from one medical facility."

Answered by AI

Is this experiment currently seeking participants?

"Indeed, the information posted on clinicaltrials.gov reveals that this ongoing medical study is still accepting participants for enrolment. This trial was first showcased to the public on June 30th 2021 and has since been modified on July 7th 2022."

Answered by AI

What goals is this experiment hoping to achieve?

"The primary goal of this 8-hour clinical trial is to observe fluctuations in systolic blood pressure from baseline. Secondary objectives include assessing the number of participants reporting a 'Feeling Scale Score' below 0, the amount of people with an exaggerated reaction to their sedentary break dose as measured by serially collected BP readings, and recording those who reported physical exhaustion scores above 9 on the Exercise-Induced Feeling Inventory scale. The Feeling Scale is single item questionnaire which quantifies pleasure or displeasure felt during physical activity on an 11 point good/bad bipolar spectre while the Physical Exhaustion Subscale consists of three fatigue related items scored on"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health

Keith Diaz 2022. "Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05353322.