WorkWell: A Pre-clinical Pilot Study of Increased Standing and Light-intensity Physical Activity in Prediabetic Sedentary Office Workers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in 2-hour postprandial area-under-the-curve blood glucose at 2 weeks
研究概览
简要总结
This study will test whether a range of pre-clinical cardiometabolic biomarkers can be improved via regular intervals of standing and light-intensity physical activity in real-world office environments.
详细描述
This pilot study is being conducted to determine whether a range of pre-clinical cardiometabolic biomarkers (measured via gut microbiome, blood draw) can be improved via regular intervals of standing and light-intensity physical activity (i.e., leisurely walking) in real-world office environments. This trial is meant to generate pilot data which will lead to additional clinical trials.
Primary Hypothesis: Increasing both standing and light-intensity physical activity will improve biomarkers of metabolic function, as measured by blood metabolites and differential abundance of gut microbiome composition, compared to a control condition of normal workplace behavior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Flow-mediated dilation outcome: Images that are obtained will be analyzed by a blinded researcher using a previously validated, edge-detection software
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women and men age 18 yrs and older
- •Holds a job where primary work activities are done seated
- •Has the space and ability to use a sit-to-stand workstation in their primary workspace
- •Works in an office setting or remotely for ≥ 4 days per week
- •Have a BMI ≥ 25.0 (≥23.0 for individuals of Asian descent)
排除标准
- •Currently taking diabetes medication
- •Taking any of the following medications or treatments:
- •Medication to control high blood pressure
- •Medication to treat high glucose
- •Blood thinners
- •Hormone replacement therapy (in the past 12 months)
- •Corticosteroids
- •High dose statins (Dr. Reaven, MD to adjudicate eligibility based on dosage)
- •2nd generation antipsychotics
- •Current or previous foot or lower limb injuries
- •Current use of sit-stand workstation
- •Current smoker
- •Neuromuscular or cardiovascular disorders or other serious active medical issues, including deep vein thrombosis or respiratory issues
- •Has a physical impairment or musculoskeletal condition that will prevent the subject from standing or light-intensity walking for a maximum of 30 minutes
- •Has been advised to avoid prolonged periods of sitting or standing by a physician or other healthcare provider
- •History of inflammatory bowel or intestinal malabsorption conditions
- •Use of prebiotics, probiotics or antibiotics in the last 3 months
- •Serious food allergies or restrictions
- •Participants who will be travelling 3 or more days out of their typical week
研究组 & 干预措施
Move, Stand
Usual behavior condition, followed by the standing condition, followed by the LPA condition.
干预措施: Standing condition (Behavioral)
Move, Stand
Usual behavior condition, followed by the standing condition, followed by the LPA condition.
干预措施: Light physical activity (LPA) condition (Behavioral)
Move, Stand
Usual behavior condition, followed by the standing condition, followed by the LPA condition.
干预措施: Usual behavior condition (Behavioral)
Stand, Move
Usual behavior condition, followed by the LPA condition, followed by the standing condition.
干预措施: Standing condition (Behavioral)
Stand, Move
Usual behavior condition, followed by the LPA condition, followed by the standing condition.
干预措施: Light physical activity (LPA) condition (Behavioral)
Stand, Move
Usual behavior condition, followed by the LPA condition, followed by the standing condition.
干预措施: Usual behavior condition (Behavioral)
结局指标
主要结局
Change in 2-hour postprandial area-under-the-curve blood glucose at 2 weeks
时间窗: 2 weeks
Participants will be asked to wear the Abbott Freestyle Libre continuous glucose monitor during the usual behavior condition (week 1) and both experimental conditions (weeks 2-3 and weeks 5-6). Research staff will insert the CGM sensor at the screening and study visits. The training for this insertion will be conducted by a registered research nurse. The CGM sensors have been designed and tested to be worn continuously for up to 14 days. Sensors will be placed and removed by trained research staff at appropriate time-points throughout the study. Postprandial period will follow a standardize lunch meal. Area-under-the-curve calculations will be based on 2 hours following delivery of this lunch meal.
次要结局
- Change in baseline workplace standing time at 2 weeks(2 weeks)
- Change in baseline workplace stepping time at 2 weeks(2 weeks)