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NCT05353322 · ClinicalTrials.gov registry record · NA

Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health

A NA study of Blood Pressure and Sedentary Behavior, sponsored by Columbia University.

Recruiting
Registry status
NA
Development phase
324
Enrollment target
1
Study location

NCT05353322 is a NA study of Blood Pressure and Sedentary Behavior that is actively recruiting participants, run by Columbia University. The registered enrollment target is 324 participants, above the 284-participant average among 101 other Blood Pressure trials with a reported enrollment target (14% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT05353322, a NA study of Blood Pressure and Sedentary Behavior, is actively recruiting participants, sponsored by Columbia University.

RECRUITING
Registry status
NA
Development phase
324 participants
Enrollment target
1
Study location

Study 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), tolerabil

Interventions

  • BEHAVIORAL Sedentary Break (Walking) Condition
  • BEHAVIORAL Sitting (Control) Condition
  • BEHAVIORAL Controlled Diet

Study Locations (1)

New York

  • Center for Behavioral Cardiovascular Health - New York

Trial Details

FieldValue
Enrollment Target 324 participants
Start Date 2022-06-30
Est. Completion 2026-03-31
Phase NA

Sponsor

Columbia University

958 total trials

What the Registry Record Tells You About NCT05353322

The ClinicalTrials.gov registry entry for NCT05353322 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 324 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 284-participant average among 101 other Blood Pressure trials with a reported enrollment target (14% higher). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Blood Pressure appearing as the primary indexed condition, and to 3 interventions - of which Sedentary Break (Walking) Condition is the first listed.

NCT05353322 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT05353322 about?

NCT05353322 is a clinical study titled "Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health". 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 sta...

What is the current status of trial NCT05353322?

This trial is currently recruiting. It is a NA study. The enrollment target is 324 participants. The study started on 2022-06-30. Estimated completion is 2026-03-31.

What conditions does trial NCT05353322 study?

This clinical trial studies the following conditions: Blood Pressure, Sedentary Behavior, Cardiometabolic Risk Factors, Glucose.

What interventions are being tested in trial NCT05353322?

The interventions under investigation include: Sedentary Break (Walking) Condition (BEHAVIORAL), Sitting (Control) Condition (BEHAVIORAL), Controlled Diet (BEHAVIORAL).

Who is sponsoring clinical trial NCT05353322?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05353322 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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