One Step at a Time: An Intervention to Reduce Sedentary Behavior Among Working Adults

August 24, 2023 updated by: University of Illinois at Urbana-Champaign

One Step at a Time: Testing the Efficacy of a Novel Social Cognitive Theory-Based Intervention to Reduce Sedentary Behavior Among Working Adults

The proposed study will test the preliminary efficacy of a novel 12-week social cognitive theory-based intervention that will target reducing daily sitting time and increasing exercise participation among middle-aged working adults. This is a population highly susceptible to excessive sedentary time and low levels of exercise engagement. This two-arm randomized controlled trial (RCT) will examine the preliminary efficacy of decreasing sedentary time in addition to increasing moderate-vigorous intensity physical activity (MVPA) engagement, compared to a group which only receives MVPA promotion.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Neha P Gothe, MA, PhD
  • Phone Number: 217.300.6183
  • Email: npg@illinois.edu

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Univeristy of Illinois Urbana-Champaign

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

41 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 45-65 years of age by study start date
  • Hold full-time employment (≥ 30 hours/week) at one or more jobs
  • Hold a sedentary-based job (which also allows for ability to freely move about during the workday)
  • Low active (engage in ≤2 days of 30+ minutes of structured moderate-vigorous intensity exercise/week)
  • Physician's consent to participate in aerobic testing and/or the exercise program (if needed based on Physical Activity Readiness Questionnaire responses)
  • Ambulatory
  • Absence of health conditions that may be made worse by exercise
  • Ability to complete all testing assessments in-person
  • Access to a laptop/desktop/phone with Zoom web-conferencing software
  • Fluent in English

Exclusion Criteria:

  • Under 45 or over 65 years of age
  • Not holding full-time employment (work < 30 hours/week at one or more jobs)
  • Hold a job(s) which is classified as light, medium, heavy, or very heavy work
  • Hold a sedentary-based job which does not allow for free movement throughout the workday (i.e., bus driver)
  • High active (engage in > 2 days or 30+ minutes of structured moderate-vigorous intensity exercise/week)
  • Non-consent of physician
  • Non-ambulatory (i.e., use of walkers, wheelchair, cane, etc.)
  • Presence of health conditions that may be made worse by exercise.
  • Unable to complete assessments in-person
  • No access to laptop/desktop/phone with Zoom software

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Decrease Sedentary Time + Increase MVPA
Participants in this group will receive a 12-week, social cognitive theory-based intervention targetting reduction of daily sedentary time. This information will be delivered to them in the form of Zoom workshops, a program workbook, personalized step count goals, and a private social media page. The aim of this component will be to have participants displace their daily sedentary time with light-intensity physical activity, such as casual walking. The second component of this intervention will be increasing participants' weekly MVPA engagement. Participants will participate in 1 live, virtual aerobics-based exercise class per week and complete 2 additional sessions on their own time. Participants will build up to exercising 150 minutes/week (the federal physical activity recommendations).
Behavioral: Decrease Sedentary Time + Increase MVPA group
12 week home-based exercise program to promote engagement of 150 min/week of moderate-vigorous intensity exercise; personalized step count goals to increase daily volume of physical activity and displacement of sedentary time
Active Comparator: Increase MVPA only
Participants in this group will only receive the MVPA-promoting component (which will be the same delivery as the intervention group). Participants in this arm will participate in 1 live, virtual aerobics-based exercise class per week (held separately from the intervention group) and will complete 2 additional exercise classes on their own time. Participants will build up to exercising 150 minutes/week (the federal physical activity recommendations).
Behavioral: Increase MVPA group
12 week home-based exercise program to promote engagement of 150 min/week of moderate-vigorous intensity exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in average daily step counts
Time Frame: Baseline,12 weeks
Participants will wear a hip-based pedometer for 7 days at baseline and 12 weeks
Baseline,12 weeks
Changes in average daily sedentary time
Time Frame: Baseline,12 weeks
Participants will wear a hip-based accelerometer for 7 days at baseline and 12 weeks to measure their daily time spent sedentary.
Baseline,12 weeks
Changes in average daily light-intensity physical activity
Time Frame: Baseline,12 weeks
Participants will wear a hip-based accelerometer for 7 days at baseline and 12 weeks to measure their daily time spent engaged in light-intensity physical activity.
Baseline,12 weeks
Changes in average daily moderate-vigorous intensity physical activity
Time Frame: Baseline, 12 weeks
Participants will wear a hip-based accelerometer for 7 days at baseline and 12 weeks to measure their daily time spent engaged in moderate-vigorous intensity physical activity.
Baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Urbana-Champaign

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Neha P Gothe, MA, PhD, University of Illinois at Urbana-Champaign

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22651

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Exercise

Clinical Trials on Decrease Sedentary Time + Increase MVPA group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings