Cardiovascular Risk FactorNCT03898206
Effects of Breaking up Prolonged Sitting on Postprandial Cardiometabolic Disease Risk Markers in South Asian Adults
A study testing Breaking up sitting with walking breaks (INT-SIT) and Prolonged sitting (SIT) in people with Cardiovascular Risk Factor and Cardiovascular Diseases, run by University of Bedfordshire at 1 site in United Kingdom.
Trial summary
The purpose of this study is to examine whether breaking up prolonged sitting with short regular bouts of walking can reduce blood sugar and cholesterol levels after eating, which are risk markers for Type 2 diabetes and heart disease. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Cardiovascular Diseases, Diabetes
- What is being tested?
- Breaking up sitting with walking breaks (INT-SIT) and Prolonged sitting (SIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Apr 2019to 20 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identified South Asian ethnicity.
- Self-report sitting at least 7 hours per day.
- Normal weight, overweight or obese.
Who cannot join
- Unable to speak and read English.
- Contraindications to performing light-intensity walking.
- Diagnosed cardiovascular disease or diabetes.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Bedfordshire
Bedford, Bedfordshire, MK41 9EA
About this study
Official title: Effects of Breaking up Prolonged Sitting on Postprandial Cardiometabolic Disease Risk Markers in Normal Weight Versus Overweight and Obese South Asian Adults
The purpose of this study is to examine whether breaking up prolonged sitting with short regular bouts of walking can reduce blood sugar and cholesterol levels after eating, which are risk markers for Type 2 diabetes and heart disease. This study will compare these responses in normal-weight versus overweight/obese South Asian adults.
Read the detailed description
Participants will attend a preliminary testing session where height, weight, body fat and waist circumference will be measured. They will be familiarised with a motorised treadmill that will be used during the experimental visit below and will take part in an exercise test to determine a light-intensity walking speed for the experimental visit.
Participants will then attend two experimental visits in a random order:
- Prolonged sitting (SIT): Participants will remain seated for 5 hours and instructed to reduce excessive movement.
- Breaking up sitting with walking breaks (INT-SIT): Participants will rise from the seated position every 30 minutes throughout the experimental period to walk on a motorised treadmill at a light intensity for 5 minutes. After performing walking activity, they will return to the seated position. In addition, blood sample will be taken at the resting position just before each physical activity bout. The activity breaks will be undertaken on 9 occasions, providing a total of 45 min of light-intensity activity.
During each visit, blood pressure will be taken 11 times and blood samples will be taken 10 times. Participants will be given a breakfast and lunch meal to consume.
- Conditions
- Cardiovascular Risk Factor, Cardiovascular Diseases, Diabetes, Physical Activity, Sedentary Lifestyle
- Being tested
- Breaking up sitting with walking breaks (INT-SIT), Prolonged sitting (SIT)
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breaking up sitting with walking breaks (INT-SIT)Other
See Breaking up sitting with walking breaks arm description
Prolonged sitting (SIT)Other
See Prolonged sitting arm description
| Study group | Role | What they receive |
|---|---|---|
| Prolonged sitting (SIT), then breaking up sitting with walking breaks (INT-SIT) | Experimental | Firstly, participants will remain seated for 5 h and instructed to reduce excessive movement, only rising from the chair to void. After a washout period of at least 3 days, they then performed the INT-SIT condition.
Prolonged sitting (SIT): See SIT arm description Breaking up sitting with walking breaks (INT-SIT): See INT-SIT arm description Receives: Other: Prolonged sitting (SIT) |
| Breaking up sitting with walking breaks (INT-SIT), then prolonged sitting (SIT) | Experimental | Firstly, participants will rise from the seated position every 30 min throughout the experimental period to walk on a motorised treadmill at a light intensity walking (as determined during the preliminary test) for 5 min. Participants will start walk on a treadmill at 30 min (so physical activity would be at 30-35 min), 60 min (physical activity will be at 60-65 min), 90 min (physical activity will be at 90-95 min), 120 min (physical activity will be 120-125 min), 150 min (physical activity will be at 150-155 min ), and 180 min (physical activity will be at 180-185 min) in the breakfast postprandial period and 30 min (physical activity will be 30-35 min), 60 min (physical activity will be at 60-65 min), and 90 min (physical activity will be at 90-95 min) in the lunch postprandial period. After performing a walking activity, they will return to the seated position. After a washout period of at least 3 days, they then performed the SIT condition.
SIT : See SIT arm description Receives: Other: Breaking up sitting with walking breaks (INT-SIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Glucose
Incremental area under the curve for each 5 h condition will be calculated for glucose
Measured: Measured over the 5 hour condition period
Secondary outcomes (8)
Postprandial Triglycerides
Incremental area under the curve for each 5 h condition will be calculated for triglycerides
Measured: Measured over the 5 hour condition period
Postprandial Insulin
Incremental area under the curve for each 5 h condition will be calculated for insulin
Measured: Measured over the 5 hour condition period
Metabolic Load Index
Incremental area under the curve for each 5 h condition will be calculated for the Metabolic Load Index (MLI).
The MLI will be calculated using the following equation:
MLI (mmol.L-1) = blood glucose (mmol.L-1) + TAG (mmol.L-1). Lower values of MLI are considered better for cardiometabolic health!
Measured: Measured over the 5 hour condition period
Resting Energy Expenditure
Incremental area under the curve for each 5 h condition will be calculated for resting energy expenditure
Measured: Measured for the 5 hour condition period
Resting Fat Oxidation
Incremental area under the curve for each 5 h condition will be calculated for resting fat oxidation
Measured: Measured for the 5 hour condition period
Resting Carbohydrate Oxidation
Incremental area under the curve for each 5 h condition will be calculated for resting carbohydrate oxidation
Measured: Measured for the 5 hour condition period
Mean Arterial Pressure
Mean Arterial Pressure (MAP) over the 5 h conditions.
The following formula will be used to calculate MAP, where P is blood pressure (systolic or diastolic):
MAP = PDiastolic + 1/3 (PSystolic - PDiastolic).
Measured: Measured over the 5 hour condition period
Heart Rate
Mean heart rate over the 5 h conditions
Measured: Measured over the 5 hour condition period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start26 Apr 2019
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bedfordshire
- Sponsor type
- University, hospital or other
- Collaborators
- Brunel University
- Responsible party
- Principal investigator, Dr Daniel Bailey, University of Bedfordshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898206
- Sponsor's protocol ID
- 2019ISPAR003
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2019
- Last updated
- 21 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Breaking up Prolonged Sitting on Postprandial Cardiometabolic Disease Risk Markers in Normal Weight Versus Overweight and Obese South Asian Adults
- ClinicalTrials.gov ID
- NCT03898206
- Acronym / sponsor ID
- 2019ISPAR003
- Conditions
- Cardiovascular Risk Factor, Cardiovascular Diseases, Diabetes, Physical Activity, Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of BedfordshireUniversity, hospital or other
- Collaborators
- Brunel University
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Posted 21 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine whether breaking up prolonged sitting with short regular bouts of walking can reduce blood sugar and cholesterol levels after eating, which are risk markers for Type 2 diabetes and heart disease. This study will compare these responses in normal-weight versus overweight/obese South Asian adults.
Detailed description
Participants will attend a preliminary testing session where height, weight, body fat and waist circumference will be measured. They will be familiarised with a motorised treadmill that will be used during the experimental visit below and will take part in an exercise test to determine a light-intensity walking speed for the experimental visit.
Participants will then attend two experimental visits in a random order:
- Prolonged sitting (SIT): Participants will remain seated for 5 hours and instructed to reduce excessive movement.
- Breaking up sitting with walking breaks (INT-SIT): Participants will rise from the seated position every 30 minutes throughout the experimental period to walk on a motorised treadmill at a light intensity for 5 minutes. After performing walking activity, they will return to the seated position. In addition, blood sample will be taken at the resting position just before each physical activity bout. The activity breaks will be undertaken on 9 occasions, providing a total of 45 min of light-intensity activity.
During each visit, blood pressure will be taken 11 times and blood samples will be taken 10 times. Participants will be given a breakfast and lunch meal to consume.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged sitting (SIT), then breaking up sitting with walking breaks (INT-SIT) | Experimental | Other: Prolonged sitting (SIT)Firstly, participants will remain seated for 5 h and instructed to reduce excessive movement, only rising from the chair to void. After a washout period of at least 3 days, they then performed the INT-SIT condition. Prolonged sitting (SIT): See SIT arm description Breaking up sitting with walking breaks (INT-SIT): See INT-SIT arm description |
| Breaking up sitting with walking breaks (INT-SIT), then prolonged sitting (SIT) | Experimental | Other: Breaking up sitting with walking breaks (INT-SIT)Firstly, participants will rise from the seated position every 30 min throughout the experimental period to walk on a motorised treadmill at a light intensity walking (as determined during the preliminary test) for 5 min. Participants will start walk on a treadmill at 30 min (so physical activity would be at 30-35 min), 60 min (physical activity will be at 60-65 min), 90 min (physical activity will be at 90-95 min), 120 min (physical activity will be 120-125 min), 150 min (physical activity will be at 150-155 min ), and 180 min (physical activity will be at 180-185 min) in the breakfast postprandial period and 30 min (physical activity will be 30-35 min), 60 min (physical activity will be at 60-65 min), and 90 min (physical activity will be at 90-95 min) in the lunch postprandial period. After performing a walking activity, they will return to the seated position. After a washout period of at least 3 days, they then performed the SIT condition. SIT : See SIT arm description |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-identified South Asian ethnicity.
- Self-report sitting at least 7 hours per day.
- Normal weight, overweight or obese.
Key exclusion criteria (3 listed)
- Unable to speak and read English.
- Contraindications to performing light-intensity walking.
- Diagnosed cardiovascular disease or diabetes.
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 |
|---|---|---|
| Breaking up sitting with walking breaks (INT-SIT)See Breaking up sitting with walking breaks arm description | Other | Breaking up sitting with walking breaks (INT-SIT), then prolonged sitting (SIT) |
| Prolonged sitting (SIT)See Prolonged sitting arm description | Other | Prolonged sitting (SIT), then breaking up sitting with walking breaks (INT-SIT) |
Primary outcome
Postprandial Glucose
Time frame: Measured over the 5 hour condition period
Incremental area under the curve for each 5 h condition will be calculated for glucose
8 secondary outcomes
Postprandial Triglycerides
Time frame: Measured over the 5 hour condition period
Postprandial Insulin
Time frame: Measured over the 5 hour condition period
Metabolic Load Index
Time frame: Measured over the 5 hour condition period
Resting Energy Expenditure
Time frame: Measured for the 5 hour condition period
Resting Fat Oxidation
Time frame: Measured for the 5 hour condition period
Resting Carbohydrate Oxidation
Time frame: Measured for the 5 hour condition period
Mean Arterial Pressure
Time frame: Measured over the 5 hour condition period
Heart Rate
Time frame: Measured over the 5 hour condition period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breaking up sitting with walking breaks (INT-SIT) and Prolonged sitting (SIT) in people with Cardiovascular Risk Factor and Cardiovascular Diseases, run by University of Bedfordshire at 1 site in United Kingdom.
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 3 inclusion and 3 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 21 Apr 2026. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 21 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postprandial Glucose (time frame: Measured over the 5 hour condition period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2026.