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Completed

NCT Number: NCT04645875

Substituting Sitting With Standing and Walking in Free-living Conditions Improves Daily Glucose Profile in South Asians

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.

Completed

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bedfordshire

Bedford, MK41 9EA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SIT regimen

Other

See SIT regimen arm description

SITless regimen

Other

See SITless regimen arm description

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Bedfordshire

Other

Collaborators

  • Brunel University

Registry information

Official study title

Substituting Sitting With Standing and Walking in Free-living Conditions Improves Daily Glucose Concentrations in South Asian Adults Living With Overweight/Obesity

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 27, 2020
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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