University of Bedfordshire
Bedford, MK41 9EA, United Kingdom
NCT Number: NCT04645875
The purpose of this study is to investigate the effects of substituting sitting under free-living conditions in South Asian adults with overweight and obesity on continuous glucose profiles.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Bedford, MK41 9EA, United Kingdom
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
See SIT regimen arm description
See SITless regimen arm description
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.
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.
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.
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.
University of Bedfordshire
Other
Substituting Sitting With Standing and Walking in Free-living Conditions Improves Daily Glucose Concentrations in South Asian Adults Living With Overweight/Obesity
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