NCT05281978

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

March 7, 2022

Last Update Submit

August 24, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Changes in average daily step counts

    Participants will wear a hip-based pedometer for 7 days at baseline and 12 weeks

    Baseline,12 weeks

  • Changes in average daily sedentary time

    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

    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

    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

Study Arms (2)

Decrease Sedentary Time + Increase MVPA

EXPERIMENTAL

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

Increase MVPA only

ACTIVE COMPARATOR

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

Interventions

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

Decrease Sedentary Time + Increase MVPA

12 week home-based exercise program to promote engagement of 150 min/week of moderate-vigorous intensity exercise

Increase MVPA only

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Illinois Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Neha P Gothe, MA, PhD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 16, 2022

Study Start

April 25, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

August 28, 2023

Record last verified: 2023-08

Locations