Coronary Artery DiseaseBOOSTSITLESSNCT06038188
Remote 3-week Booster Intervention to Reduce Sedentary Time in Patients With Coronary Artey Disease
A study testing SIT LESS Booster in people with Coronary Artery Disease, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- SIT LESS Booster
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Aug 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in the SIT LESS intervention group of the SIT LESS study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- Control group who receives usual care;
- 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.
Read the 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:
- Control group who receives usual care;
- 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)
- Conditions
- Coronary Artery Disease
- Being tested
- SIT LESS Booster
- Keywords
- Cardiac rehabilitation, e-Health, Prevention, Sedentary lifestyle, Physical activity
- Medical subject headings
- Coronary Artery Disease, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIT LESS BoosterBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group will receive usual care alone |
| SIT LESS Booster | Experimental | The intervention group will receive usual care in combination with the remote 3-week SIT LESS Booster program. Receives: Behavioral: SIT LESS Booster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Sedentary time (h/day)
Daily sedentary time as measured with the ActivPAL during 7 days
Measured: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
Secondary outcomes (8)
Number of prolonged sedentary bouts per day
Daily number of prolonged sedentary bouts (>30 min/day) as measured with the ActivPAL during 7 days
Measured: 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
Prevalence of an average sitting time >9.5 h/day measured by the ActivPAL for 7 consective days
Measured: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
daily light-intensity physical activity time (h/day)
Daily time spent in light-intensity physical activity (<3 METs) measured by the ActivPAL for 7 consective days
Measured: 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)
Daily time spent in moderate to vigorous intensity physical activity (>3 METs) measured by the ActivPAL for 7 consective days
Measured: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
daily step count (steps/day)
daily step count measured by the ActivPAL for 7 consective days
Measured: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
Uptake of the SIT LESS Booster
Number of participants participating in the SIT LESS Booster study compared to the number of eligible participants
Measured: from the start of recruitment (end August 2023) until 3 months later
Average wear time of the Activ8 in the SIT LESS Booster group
Adherence to the use of the Activ8 (wear time) measured during the intervention period in the intervention group
Measured: During the 3-week SIT LESS Booster program
Number of completed telephone calls in the SIT LESS Booster group
Number of completed telephone calls of participants in the SIT LESS Booster group
Measured: During the 3-week SIT LESS Booster program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start30 Aug 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thijs MH Eijsvogels, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038188
- Sponsor's protocol ID
- NL72604.091.20
- Other IDs
- #2017T051
- Acronym
- BOOSTSITLESS
- Status last verified
- Jun 2023
- First submitted
- 30 Aug 2023
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In line with the Open Science initiative and FAIR principles, IPD will be available on reasonable request via the corresponding author.
Publications
van Bakel BMA, Kroesen SH, Gunal A, Scheepmaker A, Aengevaeren WRM, Willems FF, Wondergem R, Pisters MF, Dam J, Janssen AM, de Bruin M, Hopman MTE, Thijssen DHJ, Eijsvogels TMH. Sedentary Behaviour Intervention as a Personalised Secondary Prevention Strategy (SIT LESS) for patients with coronary artery disease participating in cardiac rehabilitation: rationale and design of the SIT LESS randomised clinical trial. BMJ Open Sport Exerc Med. 2022 May 24;8(2):e001364. doi: 10.1136/bmjsem-2022-001364. eCollection 2022.
PubMed 35692440van Bakel BMA, Kroesen SH, Bakker EA, van Miltenburg RV, Gunal A, Scheepmaker A, Aengevaeren WRM, Willems FF, Wondergem R, Pisters MF, de Bruin M, Hopman MTE, Thijssen DHJ, Eijsvogels TMH. Effectiveness of an intervention to reduce sedentary behaviour as a personalised secondary prevention strategy for patients with coronary artery disease: main outcomes of the SIT LESS randomised clinical trial. Int J Behav Nutr Phys Act. 2023 Feb 14;20(1):17. doi: 10.1186/s12966-023-01419-z.
PubMed 36788615Kroesen SH, van Bakel BMA, de Bruin M, Pisters MF, Ortega FB, Hopman MTE, Thijssen DHJ, Bakker EA, Eijsvogels TMH. A remote booster program to attenuate sedentary behaviour in patients with coronary artery disease: A Randomized Controlled Trial. Eur J Prev Cardiol. 2025 Mar 20:zwaf162. doi: 10.1093/eurjpc/zwaf162. Online ahead of print.
PubMed 40112182
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Remote 3-week Booster Intervention to Reduce Sedentary Time in Patients With Coronary Artey Disease: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06038188
- Acronym / sponsor ID
- BOOSTSITLESS / NL72604.091.20
- Conditions
- Coronary Artery Disease
- Keywords
- Cardiac rehabilitation, e-Health, Prevention, Sedentary lifestyle, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Control group who receives usual care;
- 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.
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:
- Control group who receives usual care;
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group will receive usual care alone |
| SIT LESS Booster | Experimental | Behavioral: SIT LESS BoosterThe intervention group will receive usual care in combination with the remote 3-week SIT LESS Booster program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participation in the SIT LESS intervention group of the SIT LESS study
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIT LESS BoosterPatients 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 | Behavioural | SIT LESS Booster |
Primary outcome
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
8 secondary outcomes
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
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
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 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 step count (steps/day)
Time frame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
Uptake of the SIT LESS Booster
Time frame: from the start of recruitment (end August 2023) until 3 months later
Average wear time of the Activ8 in the SIT LESS Booster group
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Background: PubMed 35692440van Bakel BMA, Kroesen SH, Gunal A, Scheepmaker A, Aengevaeren WRM, Willems FF, Wondergem R, Pisters MF, Dam J, Janssen AM, de Bruin M, Hopman MTE, Thijssen DHJ, Eijsvogels TMH. Sedentary Behaviour Intervention as a Personalised Secondary Prevention Strategy (SIT LESS) for patients with coronary artery disease participating in cardiac rehabilitation: rationale and design of the SIT LESS randomised clinical trial. BMJ Open Sport Exerc Med. 2022 May 24;8(2):e001364. doi: 10.1136/bmjsem-2022-001364. eCollection 2022.
- Background: PubMed 36788615van Bakel BMA, Kroesen SH, Bakker EA, van Miltenburg RV, Gunal A, Scheepmaker A, Aengevaeren WRM, Willems FF, Wondergem R, Pisters MF, de Bruin M, Hopman MTE, Thijssen DHJ, Eijsvogels TMH. Effectiveness of an intervention to reduce sedentary behaviour as a personalised secondary prevention strategy for patients with coronary artery disease: main outcomes of the SIT LESS randomised clinical trial. Int J Behav Nutr Phys Act. 2023 Feb 14;20(1):17. doi: 10.1186/s12966-023-01419-z.
- Derived from this study: PubMed 40112182Kroesen SH, van Bakel BMA, de Bruin M, Pisters MF, Ortega FB, Hopman MTE, Thijssen DHJ, Bakker EA, Eijsvogels TMH. A remote booster program to attenuate sedentary behaviour in patients with coronary artery disease: A Randomized Controlled Trial. Eur J Prev Cardiol. 2025 Mar 20:zwaf162. doi: 10.1093/eurjpc/zwaf162. Online ahead of print.
- Individual participant dataSharing planned: Yes. In line with the Open Science initiative and FAIR principles, IPD will be available on reasonable request via the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thijs MH Eijsvogels, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIT LESS Booster in people with Coronary Artery Disease, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Sedentary time (h/day) (time frame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06038188, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.