Short Walks to Break Up Sitting for Type 2 Diabetes

Recruiting in Palo Alto (17 mi)

Overseen by Mary O Whipple, PhD, RN, PHN

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Minnesota

Disqualifiers: Type 1 diabetes, Uncontrolled hypertension, Renal dialysis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Type 2 diabetes (T2D) confers a high risk of cardiovascular disease (CVD), particularly among older adults who tend to be physically inactive. Prolonged sedentary behavior (SB) has been shown to negatively influence markers of cardiovascular risk (e.g., blood glucose, blood pressure), even among individuals who are physically active. Most studies that have examined the effects of breaking up SB have focused on young healthy males and prioritized glycemic outcomes. Additionally, sex differences in these outcomes have not been adequately examined. The present study will address these gaps. This 3-arm crossover randomized controlled trial will compare the effects of 3 SB conditions on markers of vascular function. The 3 conditions are: 1) 4 hours of prolonged SB, 2) 4 hours of SB broken up by 5 minutes of self-paced walking every hour, and 3) 4 hours of SB with one 20-minute bout of self-paced walking. In addition to examining the overall effects of each condition, sex differences in physiological responses will be evaluated.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment of breaking up sitting time with short walks for people with type 2 diabetes?

Research shows that breaking up long periods of sitting with light or moderate activity can help lower blood pressure in people at risk for type 2 diabetes. Additionally, a study found that reducing sitting time improved blood sugar control in people with type 2 diabetes. ^{1 2 3 4 5}

Is breaking up sitting time with short walks safe for humans?

Research suggests that taking breaks from sitting with light to moderate activity, like short walks, is generally safe and can help lower blood pressure in people at risk for type 2 diabetes. However, more studies are needed to fully understand the long-term effects on vascular health. ^{5 6 7 8 9}

How does the treatment of breaking up sitting time differ from other treatments for type 2 diabetes?

This treatment is unique because it focuses on reducing and interrupting prolonged sitting time with short walks, which can improve blood sugar control and reduce fatigue, unlike traditional treatments that primarily emphasize medication or intense exercise. ^{4 8 9 10 11}

Research Team

Mary O Whipple, PhD, RN, PHN

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for people over 60 with Type 2 diabetes who are mostly inactive, sitting for more than 6 hours a day. It's not for those on dialysis, with a history of DVT, unstable conditions, recent hormone therapy changes, meeting exercise guidelines, physical disabilities affecting movement, Type 1 diabetes or uncontrolled high blood pressure.

Inclusion Criteria

I have type 2 diabetes with an A1c of 6.5% or higher.

I can avoid food, caffeine, alcohol, exercise for 24 hours, and smoking for 12 hours before each visit.

I am a woman and have not had a period for at least 12 months.

Exclusion Criteria

You have trouble thinking and understanding things clearly, which could make it difficult for you to agree to participate in the study.

You are physically active for at least 150 minutes a week, measured using a questionnaire.

Your blood pressure is very high and not under control.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 3 different sedentary behavior conditions to assess vascular function

12 weeks

Multiple visits for each condition

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• prolonged SB (Behavioural Intervention)
• SB broken 1 (Behavioural Intervention)
• SB broken 2 (Behavioural Intervention)

Trial Overview The study tests how breaking up sitting time affects heart health in older adults with Type 2 diabetes. Participants will try three different routines: just sitting for four hours; walking five minutes every hour; and one longer walk of twenty minutes during the four hours.

Participant Groups

Group I: CON Experimental Treatment 1 Intervention

Control group

Group II: Break Experimental Treatment 1 Intervention

Group III: BOUT Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Shashank Priya

University of Minnesota

Chief Executive Officer since 2023

PhD in Materials Engineering from Penn State

Charles Semba

University of Minnesota

Chief Medical Officer since 2021

MD from the University of Minnesota Medical School

Findings from Research

The study demonstrated that sedentary behavior counseling significantly reduced total sitting time from an average of 11.8 hours to 10.29 hours over three months in 10 adults with type 2 diabetes, indicating the intervention's effectiveness.

Participants also experienced a notable improvement in glycemic control, with a decrease in HbA1c levels by 0.51%, suggesting that reducing sedentary behavior can positively impact diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sedentary Behavior Counseling Intervention in Aging People With Type 2 Diabetes: A Feasibility Study. Alothman, S., Alenazi, AM., Alshehri, MM., et al.[2021]

A pilot study involving 82 university students showed that a text message-based intervention significantly increased nonsedentary behaviors, such as taking more breaks from sitting and engaging in light to moderate physical activity over 6 weeks.

The intervention also improved self-efficacy beliefs regarding reducing sedentary behavior, which were found to predict actual reductions in sitting time and increases in physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Nonsedentary Behaviors in University Students Using Text Messages: Randomized Controlled Trial. Cotten, E., Prapavessis, H.[2018]

Experimental studies support the idea that reducing and breaking up sedentary time can lower the risk of type 2 diabetes (T2D), aligning with previous epidemiological evidence.

New findings are prompting updates to diabetes-related physical activity guidelines, emphasizing the importance of not just engaging in moderate-vigorous exercise, but also minimizing and interrupting prolonged sitting throughout the day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sitting Less and Moving More: Improved Glycaemic Control for Type 2 Diabetes Prevention and Management. Dempsey, PC., Owen, N., Yates, TE., et al.[2023]

A randomized controlled trial involving 187 young adults at risk of type 2 diabetes showed that a structured education workshop aimed at reducing sedentary behavior did not lead to significant changes in sitting time after 12 months.

The lack of effectiveness may be attributed to the brief nature of the intervention and a possible misfocus on increasing physical activity rather than specifically reducing sitting time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomised Controlled Trial to Reduce Sedentary Time in Young Adults at Risk of Type 2 Diabetes Mellitus: Project STAND (Sedentary Time ANd Diabetes). Biddle, SJ., Edwardson, CL., Wilmot, EG., et al.[2022]

Sedentary behavior, defined as sitting, is a significant risk factor for various chronic diseases, including type 2 diabetes, cardiovascular disease, and certain cancers, even when accounting for physical activity levels.

Breaking up prolonged sitting with light movement or substituting sitting with standing can improve glucose regulation, suggesting that reducing sedentary time is crucial for managing and preventing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sedentary behaviour as a new behavioural target in the prevention and treatment of type 2 diabetes. Henson, J., Dunstan, DW., Davies, MJ., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sedentary Behavior Counseling Intervention in Aging People With Type 2 Diabetes: A Feasibility Study. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

The effects of a pedometer-based behavioral modification program with telephone support on physical activity and sedentary behavior in type 2 diabetes patients. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Prospectively Reallocating Sedentary Time: Associations with Cardiometabolic Health. [2021]

4. England pubmed.ncbi.nlm.nih.gov

A randomised-controlled feasibility study of the REgulate your SItting Time (RESIT) intervention for reducing sitting time in individuals with type 2 diabetes: study protocol. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Acute effects of sedentary breaks on vascular health in adults at risk for type 2 diabetes: A systematic review. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Increasing Nonsedentary Behaviors in University Students Using Text Messages: Randomized Controlled Trial. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Too Little Exercise and Too Much Sitting: Inactivity Physiology and the Need for New Recommendations on Sedentary Behavior. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Sitting Less and Moving More: Improved Glycaemic Control for Type 2 Diabetes Prevention and Management. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

A Randomised Controlled Trial to Reduce Sedentary Time in Young Adults at Risk of Type 2 Diabetes Mellitus: Project STAND (Sedentary Time ANd Diabetes). [2022]

10. Ireland pubmed.ncbi.nlm.nih.gov

Prolonged uninterrupted sitting increases fatigue in type 2 diabetes. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Sedentary behaviour as a new behavioural target in the prevention and treatment of type 2 diabetes. [2018]