- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04645875
Substituting Sitting With Standing and Walking in Free-living Conditions Improves Daily Glucose Profile in South Asians
Substituting Sitting With Standing and Walking in Free-living Conditions Improves Daily Glucose Concentrations in South Asian Adults Living With Overweight/Obesity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Anthropometric measurement tools, including a stadiometer, a measurement tape and a digital weighing scale, an activity monitor and a Flash Glucose Monitor and sensor, were posted to the participants' home or workplace or the research team dropped all these items at participants' doorstep to allow participants to take their measures including height, weight, and waist circumference.
Participants performed a try-out day of the SITless regimen after preliminary testing and before the first experimental regimen. Participants were only eligible for inclusion if they were able to adhere to the experimental protocol (i.e., substitute a minimum of 5-h/day sitting with ≥2-h of self-perceived light walking and ≥3-h of standing), assessed via monitoring with an activPAL. Participants were provided with a second attempt if required.
After the try-out day, participants were set up with the FGM and activPAL, which were both worn throughout the experimental period. Setup was completed 24-h before the commencement of the first experimental regimen and subsequently worn for 11 days (i.e., 2* 4-day regimens and 3 days washout). Regimen 1 (SIT or SITless) took place over 4 days (day 1-4: Monday to Thursday), followed by a 3-day washout period (day 5-7: Friday to Sunday), followed by regimen 2 (SIT or SITless) for 4 days (day 8-11: Monday to Thursday). Participants were informed of the order of their experimental regimens and provided verbal and written guidance on how to complete the protocols. The experimental regimens were as follows:
- SIT regimen: Participants were instructed to restrict walking to ≤1 h/day and standing to ≤1 h/day during their waking day. Participants were allowed to perform their daily activities, including cooking and other household activities, within the 2-h of permitted walking and standing.
- SITless regimen: Participants were instructed to substitute a minimum of 5-h/day sitting with ≥3-h of standing and ≥2-h of self-perceived LPA in addition to interrupting their sitting for 2-5-min every 30-min. A list of activities (including walking at a slow pace, walking on the spot, jumping up and down, and standing) was provided as examples of activities that participants could perform during this regimen. Participants received feedback on their non-sitting time and the number of light and moderate-intensity steps from the try-out day. They were guided towards achieving compliance in this regimen by identifying potential activities they could engage in to interrupt sitting, reviewing their number of sitting interruptions and aiming to accumulate approximately 12,000 steps per day (6,000 steps being equivalent to 1-h of moderate-intensity walking).
Participants were asked to refrain from food and drink containing alcohol for 24-h before and to avoid performing structured exercise for 48-h before the experimental protocol commenced and throughout the entire experimental period (a total of 11-days). A kitchen scale was provided so participants could weigh and record all food and beverage consumption in a diary during the first 4-day regimen and replicate this dietary intake exactly during the second 4-day regimen. Participants were instructed to consume a standardised diet (at least 50% carbohydrate) in order to reduce dietary heterogeneity within the study population. Participants were advised that the meals were spaced evenly throughout the day with 3 to 4-h intervals, with snacks consumed between meals to ensure three distinct and consistent glucose responses across each day.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bedford, United Kingdom, MK41 9EA
- University of Bedfordshire
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Self-identified South Asian ethnicity.
- Self-report sitting at least 7 hours per day.
- Overweight or obese (BMI>23.0 kg/m2)
Exclusion Criteria:
- Unable to speak and read English.
- Not able to perform light-intensity activities.
- Diagnosed cardiovascular disease or diabetes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SIT regimen, then SITless regimen
Firstly, participants performed the SIT regimen (4 days) where they were instructed to restrict walking to ≤1 h/day and standing to ≤1 h/day during their waking day. Participants were allowed to perform their daily activities, including cooking and other household activities, within the 2-h of permitted walking and standing. After a washout period of 3 days, they then performed the SITless regimen (4 days). SIT regimen: See SIT regimen arm description SITless regimen: See SITless regimen arm description |
See SIT regimen arm description
|
|
Experimental: SITless regimen, then SIT regimen
Firstly, participants performed the SITLess regimen (4 days) where they were instructed to substitute a minimum of 5-h/day sitting with ≥3-h of standing and ≥2-h of self-perceived LPA in addition to interrupting their sitting for 2-5-min every 30-min. A list of activities (including walking at a slow pace, walking on the spot, jumping up and down, and standing) was provided as examples of activities that particpants could perform during this regimen. After a washout period of 3 days, they then performed the SIT regimen (4 days). SITless regimen: See SITless regimen arm description SIT regimen: See SIT regimen arm description |
See SITless regimen arm description
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glycaemia
Time Frame: Mean net incremental area under the curve for waking hours (16 h) interstitial glucose concentration per day for 4 valid days during each intervention
|
Net incremental area under the curve (iAUC), calculated by subtracting waking glucose concentration for each day from the total AUC. Waking hours were identified individually for each participant from activPAL data and then normalised to a 16 h day. Each of these variables was calculated as the mean of valid days within each regimen. A minimum of one valid day that coincided with both FGM and activPAL data was required in each experimental regimen for inclusion in the analysis. |
Mean net incremental area under the curve for waking hours (16 h) interstitial glucose concentration per day for 4 valid days during each intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sitting Time
Time Frame: Mean total sitting time per day for 4 valid days during each intervention
|
Total sitting time was measured 24 h/day during each activity regimen using an activPAL3 activity monitor. ActivPAL3 data were processed using ProcessingPAL software. After an automated estimate of valid data using the valid wear criteria, ProcessingPAL summary outputs variables were produced in a Microsoft Excel sheet. A minimum of one valid day that coincided with both FGM and activPAL data was required in each experimental regimen for inclusion in the analysis. |
Mean total sitting time per day for 4 valid days during each intervention
|
|
Standing Time
Time Frame: Mean standing time per day for 4 valid days during each intervention
|
Physical activity patterns was measured 24 h/day during each activity regimen using an activPAL3 activity monitor. ActivPAL3 data was processed using ProcessingPAL software. After an automated estimate of valid data using the valid wear criteria, ProcessingPAL summary outputs variables were produced in a Microsoft Excel sheet. A minimum of one valid day that coincided with both FGM and activPAL data was required in each experimental regimen for inclusion in the analysis. |
Mean standing time per day for 4 valid days during each intervention
|
|
Total Stepping Time
Time Frame: Mean total stepping time per day for 4 valid days during each intervention
|
Physical activity patterns were measured 24 h/day during each activity regimen using an activPAL3 activity monitor. ActivPAL3 data were processed using ProcessingPAL software. After an automated estimate of valid data using the valid wear criteria, ProcessingPAL summary outputs variables were produced in a Microsoft Excel sheet. A minimum of one valid day that coincided with both FGM and activPAL data was required in each experimental regimen for inclusion in the analysis. |
Mean total stepping time per day for 4 valid days during each intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kamalesh DEY, PhD, University of Bedfordshire
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020ISPAR006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Cardiovascular Diseases
-
Hull University Teaching Hospitals NHS TrustNot yet recruitingCardiovascular Surgery | Cardiovascular Diseases (CVD)United Kingdom
-
Weill Medical College of Cornell UniversityAmerican Heart AssociationRecruitingCardiovascular | Cardiovascular Health | Cardiovascular (CV) Risk | Cardiovascular Disease (CVD) Risk FactorsUnited States
-
Fu Jen Catholic UniversityRecruitingCardiovascular Disease | Cardiovascular SurgeryTaiwan
-
Medical College of WisconsinNational Center for Complementary and Integrative Health (NCCIH)CompletedCardiovascular Diseases | Cardiovascular Risk Factor | Cardiovascular HealthUnited States
-
Hospital Mutua de TerrassaCompleted
-
IRCCS Policlinico S. DonatoIRCCS San Raffaele; Fondazione Policlinico Universitario Agostino Gemelli IRCCS and other collaboratorsRecruitingCardiovascular Risk | Genetic Cardiovascular RiskItaly
-
Oregon Health and Science UniversityCompletedCardiovascular Disease | Cardiovascular Risk FactorsUnited States
-
Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
-
Groupe Hospitalier Paris Saint JosephTerminatedCARDIOVASCULAR DISEASESFrance
-
Children's Hospital Medical Center, CincinnatiRecruitingCardiovascular Diseases (CVD)United States
Clinical Trials on SIT regimen
-
Beijing Sport UniversityCompleted
-
Universiti Tunku Abdul RahmanCompletedOverweight and ObesityMalaysia
-
Montclair State UniversityEnrolling by invitationOverweight and ObesityUnited States
-
University of BedfordshireBrunel UniversityCompletedCardiovascular Diseases | Diabetes | Physical Activity | Sedentary Lifestyle | Cardiovascular Risk FactorUnited Kingdom
-
University of NottinghamCompletedSedentary BehaviorUnited Kingdom
-
Beijing Sport UniversityCompleted
-
Riphah International UniversityCompletedCerebral PalsyPakistan
-
Hamilton Health Sciences CorporationOntario Ministry of Health and Long Term CareUnknownCerebrovascular AccidentCanada
-
The University of Texas Health Science Center,...Department of Defense / Congressionally Mandated Research Program (CDMRP)Not yet recruitingStress, PsychologicalUnited States