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临床试验/NCT04645875
NCT04645875已完成不适用

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

University of Bedfordshire1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2020年11月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
Glycaemia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Self-identified South Asian ethnicity.
  • Self-report sitting at least 7 hours per day.
  • Overweight or obese (BMI>23.0 kg/m2)

排除标准

  • Unable to speak and read English.
  • Not able to perform light-intensity activities.
  • Diagnosed cardiovascular disease or diabetes.

结局指标

主要结局

Glycaemia

时间窗: 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.

次要结局

  • Sitting Time(Mean total sitting time per day for 4 valid days during each intervention)
  • Standing Time(Mean standing time per day for 4 valid days during each intervention)
  • Total Stepping Time(Mean total stepping time per day for 4 valid days during each intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Daniel Bailey

Reader in Sedentary Behaviour and Health

University of Bedfordshire

研究点 (1)

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