Remote 3-week Booster Intervention to Reduce Sedentary Time in Patients With Coronary Artey Disease (BOOSTSITLESS)

March 26, 2024 updated by: Radboud University Medical Center

Effectiveness of a Remote 3-week Booster Intervention to Reduce Sedentary Time in Patients With Coronary Artey Disease: a Randomized Clinical Trial.

The goal of this clinical trial is to learn about the effect of a booster program aiming to lower daily sitting time (SIT LESS Booster program) compared to usual care in patient with coronary heart problems. The main question it aims to answer is: What is the effect of the SIT LESS Booster on sedentary time and physical activity levels in patient with coronary artery disease who participated in cardiac rehabilitation.

Participants will be randomized into 2 groups:

  1. Control group who receives usual care;
  2. SIT LESS Booster group who receives usual care + a remote 3-week SIT LESS Booster program.

Objectively measured changes in daily sitting time from pre- to post SIT LESS Booster will be compared between groups to see if participants in the SIT LESS Booster group are able to reduce daily sedentary time more compared to participants in the control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

High levels of sedentary time (ST) are observed in patients with coronary artery disease (CAD) and are associated with adverse health outcomes. Behavioural interventions targeting ST are effective in the short-term, but effects seem to diminish at long-term follow-up. Short-term (telephonic) booster programs can induce sustainable physical activity behavioural changes. However, the effects of a booster ST reduction program are unknown. Therefore, we aim to assess the effect of the SIT LESS Booster on sedentary time and physical activity levels in patient with coronary artery disease who participated in cardiac rehabilitation.

All participants took already part in a special cardiac rehabilitation program aiming to lower daily sitting time between May 2021 and April 2022. For this study, they will be randomized into 2 groups:

  1. Control group who receives usual care;
  2. SIT LESS Booster group who receives usual care + a remote 3-week SIT LESS Booster program.

The SIT LESS Booster program consists of:

  • Telephone consultation in which the participants are informed about the negative effects of high daily sitting time, discuss personal goals to lower daily sitting time and make an action plan to reach the goals.
  • Use of a pocket-worn activity tracker to get insight in their own daily sitting time. The activity tracker can be connected to a smartphone application. Besides, the activity tracker buzzes when a person sits more than 30 consecutive minutes as a reminder to stand up.
  • Weekly telephone calls to discuss the progress regarding their personal sit less goals.

In both groups, daily sitting time will be measured at the start of the study and at the end of the SIT LESS Booster program using the ActivPAL.

Data analysis will be conducted using R and p-values of <0.05 will be considered statistically significant. Changes in daily ST will be compared between groups using a linear mixed model.

This trial was approved by the Medical Ethics Committee of the Radboud university medical center (NL72604.091.20)

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • 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 Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525GA
        • Radboudumc

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

• Participation in the SIT LESS intervention group of the SIT LESS study

Exclusion Criteria:

  • Unable to give informed consent
  • Wheelchair-bounded / not physically able to stand or walk.
  • Language barrier
  • Coronary arterial bypass graft surgery expected within 8 weeks after inclusion
  • New York Heart Association class III or IV heart failure
  • Participation in another interventional study targeting SB or PA

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
The control group will receive usual care alone
Experimental: SIT LESS Booster
The intervention group will receive usual care in combination with the remote 3-week SIT LESS Booster program.
Behavioral: SIT LESS Booster

Patients allocated to the SIT LESS Booster group receive usual care in combination with the SIT LESS Booster program.

The SIT LESS Booster program consists of: 1) The use of the pocket-worn activity tracker (Activ8sit). The activity tracker can be connected to an app to track the daily sitting time. Besides, the device buzzes when a person sits more than 30 consective minutes a s a reminder to stand up and move; 2) Telephone consultation (TC1) during which the researcher and patients will reactivate knowledge on the detrimental health effects of SB, discuss patients' personal goals and motivation, and collaboratively set action plans for reducing SB in the upcoming week (±20 minutes); and 3) Weekly telephone calls (TC2 and TC3) to evaluate sedentery behaviour of the preceding week (±10 minutes).

The SIT LESS Booster will be delivered completely remote

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Sedentary time (h/day)
Time Frame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
Daily sedentary time as measured with the ActivPAL during 7 days
Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of prolonged sedentary bouts per day
Time Frame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
Daily number of prolonged sedentary bouts (>30 min/day) as measured with the ActivPAL during 7 days
Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
Prevalence of a sitting time >9.5 h/day
Time Frame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
Prevalence of an average sitting time >9.5 h/day measured by the ActivPAL for 7 consective days
Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
daily light-intensity physical activity time (h/day)
Time Frame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
Daily time spent in light-intensity physical activity (<3 METs) measured by the ActivPAL for 7 consective days
Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
daily moderate-to-vigorous-intensity physical activity time (h/day)
Time Frame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
Daily time spent in moderate to vigorous intensity physical activity (>3 METs) measured by the ActivPAL for 7 consective days
Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
daily step count (steps/day)
Time Frame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
daily step count measured by the ActivPAL for 7 consective days
Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
Average wear time of the Activ8 in the SIT LESS Booster group
Time Frame: During the 3-week SIT LESS Booster program
Adherence to the use of the Activ8 (wear time) measured during the intervention period in the intervention group
During the 3-week SIT LESS Booster program
Number of completed telephone calls in the SIT LESS Booster group
Time Frame: During the 3-week SIT LESS Booster program
Number of completed telephone calls of participants in the SIT LESS Booster group
During the 3-week SIT LESS Booster program
Uptake of the SIT LESS Booster
Time Frame: from the start of recruitment (end August 2023) until 3 months later
Number of participants participating in the SIT LESS Booster study compared to the number of eligible participants
from the start of recruitment (end August 2023) until 3 months later

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Thijs MH Eijsvogels, PhD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 30, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

August 30, 2023

First Submitted That Met QC Criteria

September 7, 2023

First Posted (Actual)

September 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL72604.091.20
  • #2017T051 (Other Grant/Funding Number: senior E-Dekker grant)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In line with the Open Science initiative and FAIR principles, IPD will be available on reasonable request via the corresponding author.

IPD Sharing Time Frame

IPD will be availabe after publication of the results by the research team.

IPD Sharing Access Criteria

All data will be stored in the Digital Research Environment (DRE, mydre. org), an online, cloud- based, globally available research platform. The DRE facilitates users to collaborate on research projects within the boundaries of data management regulations (General Data Protection Regulation and Good Clinical Practice compliant) in a flexible and safe way regarding security, Information and Communication Technology (ICT) infrastructure and audit trail.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

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.

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