Stand up for Your Health With a Sit-stand Desk

Stand Up for Your Health: A Randomized Study

More than 84 million - or 1 out of every 3 U.S. adults - have prediabetes, a condition that if not treated often leads to type 2 diabetes within five years. Average medical expenditures among diabetics are about 2.3 times higher than expenditures for people without diabetes. Physical inactivity and elevated body mass index (BMI) are major risk factors for the disease. Sedentary behavior is becoming increasingly prevalent with the growth of a 'work from home' culture, most recently driven by the COVID-19 pandemic. Cross-sectional epidemiologic data report significant associations between high amounts of sedentary (sitting) time and prevalent cardiovascular disease and diabetes. In our pilot study of 15 subjects with sedentary office jobs, 6 months of sit-stand desk use resulted in a 23% improvement in insulin resistance, most substantial in those who decreased daily sitting by over 90 minutes/day. Additional improvements in vascular endothelial function and triglyceride levels were seen without any change in exercise activity, step counts, or body weight. These findings not only corroborate epidemiologic findings on this topic but suggest causality and warrant a randomized control trial.

The investigators hypothesize that adult subjects at-risk for diabetes will improve insulin sensitivity, metabolic and vascular (endothelial) health with a sit-stand desk intervention at work (whether in the office or at home), in the context of a randomized, controlled trial. The investigators will randomize 198 sedentary office workers with a BMI≥25 at risk for type 2 diabetes mellitus in a 1:1:1 ratio of three groups: (a) sit-stand desk intervention targeting 2 hours standing per day; (b) sit-stand desk intervention targeting 3 hours standing per day; or (c) control arm over 6 months. The block randomization design will allow for important dose-response analyses.

The investigators will objectively quantify standing time, sedentary time, sedentary bouts, daily steps, and exercise activity times using a compact and re-usable accelerometer that adheres to the subject's thigh. This will provide objective assessments of activity levels and sedentary times for 7 full days each at baseline, 3 and 6 months. The device is equipped with an inclinometer to classify posture (sitting verses standing).

Study Overview

• Status: Recruiting
• Conditions: Obesity; Metabolic Syndrome; Sedentary Behavior; Pre Diabetes
• Intervention / Treatment: Other: Control; Other: 2-Hour Stand Group; Other: 3-Hour Stand Group

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacquelyn Kulinski, MD; Phone Number: 414-955-6896; Email: jakulinski@mcw.edu
• Study Contact Backup: Name: Ryan Kacala; Phone Number: 414-955-6885; Email: rkacala@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin
      • Contact: Jacquelyn P Kulinski, MD; Phone Number: 414-955-6896; Email: jakulinski@mcw.edu
      • Contact: Ryan Kacala; Phone Number: 414-955-6885; Email: rkacala@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Overweight or obese (body mass index > 25 kg/m2)
2. An employee of the Medical College of Wisconsin with "sedentary" jobs, defined as spending at least 75% of their (8 hours or more) workday sitting at a desk (at home or in an office)

3. Defined as "at-risk" for diabetes, defined as either:

   1. Prediabetes (HbA1c of 5.7% to 6.4%) or a fasting glucose of 100 to 125 mg/dL

   2. Having one or more additional risk factors: (beyond BMI>25)

      • Age 45 years or older
      • Family history of diabetes mellitus in a first-degree relative
      • Physical inactivity (no structured exercise activity)
      • History of gestational diabetes, hypertension, or dyslipidemia
      • African American, Alaska Native, American Indian, Asian American, Hispanic/Latino, Native Hawaiian, or Pacific Islander ethnicity

Exclusion Criteria:

1. Established cardiovascular disease (myocardial infarction, coronary stent, coronary artery bypass grafting, cardiac transplant, or angina)
2. Established congestive heart failure or cardiomyopathy
3. Established peripheral vascular disease
4. Established diabetes (HbA1c ≥ 6.5% or on diabetes medications or insulin)
5. Chronic musculoskeletal disorders involving the lower extremities, such as arthritis of the knees or hips, or regular use of ambulatory assist devices such as a walker or cane
6. Neuropathy of any etiology
7. Positional syncope or history of orthostasis
8. Less than 4 days/week at any single office (or work-from-home) location.
9. Current use of a standing desk for work
10. Tobacco use within the previous 12 months
11. Current illicit drug use or excessive alcohol use (defined as more than 14 drinks/week for women, more than 28 drinks/week for men)
12. Steroid use ≥21 days/year
13. Fasting triglyceride level ≥ 500 mg/dL
14. Thyroid disease
15. Uncontrolled or untreated hypertension(>150/90 mm Hg)
16. Pregnant or lactating (or plans to become pregnant in the next 6 months)
17. LDL cholesterol ≥ 190mg/dL
18. Currently enrolled or plans to diet or join a weight loss program over the next 6 months.
19. Non-English speaker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; Subjects will not receive a sit/stand desk for the duration of the study and will be asked to follow their normal work day routine.	Other: Control; No intervention.
Active Comparator: 2-Hour Group; Sit-stand desk intervention group, subjects are asked to maintain the desk in the standing position at LEAST 2 hours each work day.	Other: 2-Hour Stand Group; Subjects will also receive a weekly email/text reminding them to maintain the desk in the standing position at LEAST 2 hours each work day.
Active Comparator: 3-Hour Group; Sit-stand desk intervention group, subjects are asked to maintain the desk in the standing position at LEAST 3 hours each work day.	Other: 3-Hour Stand Group; Subjects will also receive a weekly email/text reminding them to maintain the desk in the standing position at LEAST 3 hours each work day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin sensitivity (HOMA-IR)	Determine if use of a sit-stand desk improves insulin sensitivity and ascertain if there is a dose-response relationship with changes in sedentary time.	baseline to 6 months and baseline to 3 months changes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c, fasting glucose, fasting insulin	Determine if use of a sit-stand desk improves insulin sensitivity.	baseline to 6 months and baseline to 3 months changes
metabolic syndrome and metabolic syndrome severity (MetS) score	Determine if use of a sit-stand desk at work improves metabolic health, as assessed by number of (NCEP ATP III) metabolic syndrome criteria and MetS severity score, in sedentary office workers at-risk for type 2 diabetes mellitus.	baseline to 6 months and baseline to 3 months changes
fasting triglycerides, very low density lipoprotein (VLDL)	To quantify changes in serum fasting triglyceride levels and triglyceride-rich, remnant lipoproteins with the sit-stand desk (compared to no desk), while accounting for dietary intake.	baseline to 6 months and baseline to 3 months changes
vascular endothelial function (superficial femoral and brachial arteries) and resilience to a high-glucose load	To measure the changes in vascular endothelial function with the sit-stand desk compared to control.	baseline to 6 months and baseline to 3 months changes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
free fatty acids	Measure the impact of the sit-stand desk on changes in fasting serum free fatty acids (FFAs) and correlate with changes in endothelial function.	baseline to 6 months and baseline to 3 months changes
Acceptability Questionnaire	Includes questions on ease of use, comfort, perceived work productivity, and musculoskeletal discomforts related to use of the sit-stand desk. Higher scores are more favorable.	6 months

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin

Publications and helpful links

General Publications

• Bodker A, Visotcky A, Gutterman D, Widlansky ME, Kulinski J. The impact of standing desks on cardiometabolic and vascular health. Vasc Med. 2021 Aug;26(4):374-382. doi: 10.1177/1358863X211001934. Epub 2021 Apr 5. Erratum In: Vasc Med. 2023 Feb;28(1):NP1.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Anticipated): December 31, 2027
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: October 15, 2022
• First Submitted That Met QC Criteria: October 15, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Physical Activity; Obesity; Insulin resistance; Overweight; Metabolic Syndrome; Cardiovascular; Sedentary; Pre Diabetes; Standing desk; Sit-stand desk
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Insulin Resistance; Hyperinsulinism; Hyperglycemia; Metabolic Syndrome; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: 44431

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Within 1 year of completion of all studies procedures
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No