Stand up for Your Health With a Sit-stand Desk

Obesity Clinical Trial

Official title:

Stand Up for Your Health: A Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05585190
• Other study ID #: 44431
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: Medical College of Wisconsin
• Contact: Jacquelyn Kulinski, MD
• Phone: 414-955-6896
• Email: jakulinski[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Metabolic Syndrome
• Obesity
• Pre Diabetes
• Prediabetic State
• Sedentary Behavior

Intervention

Other:
• Control
No intervention.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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