Short Walks to Break Up Sitting for Type 2 Diabetes

Overseen By study coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

80 Participants Needed

Trial Summary

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}

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.

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.

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
• SB broken 1
• SB broken 2

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+

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 24-week behavioral modification program using pedometers and telephone support significantly increased physical activity by an average of 2744 steps per day and reduced sedentary behavior by 23 minutes per day in type 2 diabetes patients.

These positive changes in physical activity and reduced sedentary time were still evident one year later, with an increase of 1872 steps per day and a decrease of 12 minutes in sedentary behavior, demonstrating the program's lasting impact.

NCBI (Pubmed)

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. De Greef, KP., Deforche, BI., Ruige, JB., et al.[2022]

In a study of 808 participants at high risk for type 2 diabetes, reallocating 30 minutes from sedentary behavior to light-intensity physical activity (LPA) led to significant reductions in waist circumference and glucose levels, indicating improved cardiometabolic health.

The most substantial benefits were observed when reallocating 30 minutes from sedentary behavior to moderate-to-vigorous intensity physical activity (MVPA), which resulted in greater reductions in waist circumference and glucose levels, highlighting the importance of higher intensity activities for health improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospectively Reallocating Sedentary Time: Associations with Cardiometabolic Health. Yates, T., Edwardson, CL., Henson, J., et al.[2021]

This study involves a feasibility trial with 70 participants aged 18-85 with type 2 diabetes, aiming to assess the effectiveness of the RESIT intervention, which includes personalized behavior change techniques to reduce prolonged sitting.

The RESIT intervention combines online education, health coaching, and self-selected tools to encourage breaking up sitting time, with outcomes measured over 24 weeks to evaluate its impact on various health aspects, including cardiometabolic health and psychological well-being.

NCBI (Pubmed)

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. Bailey, DP., Edwardson, CL., Pappas, Y., et al.[2021]

Breaking up prolonged sedentary behavior with light to moderate activity can significantly lower blood pressure in individuals at elevated risk for type 2 diabetes, based on a systematic review of 20 articles.

However, the limited number of studies and their inadequate statistical power for assessing other vascular health outcomes, like flow-mediated dilation, means more research is needed to fully understand the benefits of interrupting sedentary behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effects of sedentary breaks on vascular health in adults at risk for type 2 diabetes: A systematic review. Whipple, MO., Masters, KS., Huebschmann, AG., et al.[2022]

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]

Sitting for long periods has harmful effects on cardiovascular and metabolic health, even for those who meet physical activity guidelines, highlighting the need to address sedentary behavior as a serious health risk.

Emerging evidence suggests that the physiological effects of inactivity are distinct from those of regular exercise, indicating that reducing sitting time and increasing breaks from sitting should be considered in health recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Too Little Exercise and Too Much Sitting: Inactivity Physiology and the Need for New Recommendations on Sedentary Behavior. Hamilton, MT., Healy, GN., Dunstan, DW., et al.[2022]

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]

In a randomized crossover trial, prolonged uninterrupted sitting was found to increase fatigue by 29% in individuals with type 2 diabetes compared to days with regular activity breaks.

This finding suggests that incorporating brief activity breaks into daily routines could improve quality of life and productivity for people with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged uninterrupted sitting increases fatigue in type 2 diabetes. Dempsey, PC., Dunstan, DW., Larsen, RN., et al.[2019]

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]