30 Participants Needed

Strategies to Reduce Sedentary Time for Type 2 Diabetes

MO
Overseen ByMary O Whipple, PhD, RN, PHN
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What data supports the effectiveness of the treatment Collaborative Solutions for Breaking up Sedentary Time for Type 2 Diabetes?

Research shows that reducing sitting time can help manage type 2 diabetes by improving blood sugar control. Studies have found that programs encouraging people to sit less and move more can decrease sitting time and improve health outcomes for those with type 2 diabetes.12345

Is reducing sedentary time safe for humans?

The studies on reducing sedentary time, including those for people at risk of type 2 diabetes, do not report any safety concerns, suggesting that it is generally safe for humans.24567

How is the treatment 'Collaborative Solutions for Breaking up Sedentary Time' different from other treatments for type 2 diabetes?

This treatment is unique because it focuses on reducing sedentary time (sitting time) as a way to manage type 2 diabetes, rather than relying solely on traditional methods like medication or intense physical activity. It emphasizes breaking up long periods of sitting with light movement, which has been shown to improve blood sugar control.358910

What is the purpose of this trial?

The disparate burden of Type 2 Diabetes (T2D) faced by Black individuals makes attention to preventing or delaying the development of T2D and its associated cardiovascular (CV) complications, essential.Similar to differences in cardiovascular disease (CVD) rates across racial and ethnic groups of older people, there are differences in engagement in physical activity (PA), a significant contributor to CVD. Black adults are less likely to engage in physical activity PA than their non-Hispanic White peers, with 26.7% of Black Minnesotans reporting that they did not engage any leisure-time PA in the past month, compared to 19.6% of non-Hispanic White Minnesotans. Notably, recent research has demonstrated that high amounts SB (i.e., sitting or lying with low levels of energy expenditure) also have significant detrimental effects on health, beyond those of physical inactivity. Experimental data from lab-based studies demonstrate that breaking up prolonged SB can rapidly improve markers of cardiometabolic risk (e.g., glucose and endothelial function) but the majority of these studies have focused on young, healthy, White adults. Given the significant inequities and health disparities faced by Black individuals and the lack of adequate representation of Black older adults in studies examining SB in individuals with T2D, understanding psychosocial and societal contributors to and consequences of SB experienced by this population is an essential first step toward developing relevant interventions targeting SB, and ultimately, CV health.The disparate burden of T2D faced by Black individuals makes attention to preventing or delaying the development of T2D and its associated CV complications, essential.Similar to differences in CVD rates across racial and ethnic groups of older people, there are differences in engagement in physical activity (PA), a significant contributor to CVD. Black adults are less likely to engage in PA than their non-Hispanic White peers, with 26.7% of Black Minnesotans reporting that they did not engage any leisure-time PA in the past month, compared to 19.6% of non-Hispanic White Minnesotans. Notably, recent research has demonstrated that high amounts SB (i.e., sitting or lying with low levels of energy expenditure) also have significant detrimental effects on health, beyond those of physical inactivity. Experimental data from lab-based studies demonstrate that breaking up prolonged SB can rapidly improve markers of cardiometabolic risk (e.g., glucose and endothelial function) but the majority of these studies have focused on young, healthy, White adults. Given the significant inequities and health disparities faced by Black individuals and the lack of adequate representation of Black older adults in studies examining SB in individuals with T2D, understanding psychosocial and societal contributors to and consequences of SB experienced by this population is an essential first step toward developing relevant interventions targeting SB, and ultimately, CV health.The goal is to develop a deeper understanding of individuals' experiences of sedentary behavior (SB) and collaborate to design strategies to reduce SB. Using the Center for Chronic Disease Reduction and Equity Promotion Across Minnesota (C2DREAM) conceptual model, social-ecological framework, and COM-B model, the study will seek to understand the relationship between SB and individual, relationship, community, and societal factors. The study will also examine the context of SB and strategies that participants have used and could or would consider using to break up the time they spend sitting.

Research Team

MO

Mary O Whipple, PhD, RN, PHN

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for Black older adults with Type 2 Diabetes who are interested in reducing sedentary behavior to potentially improve their cardiovascular health. The study aims to understand and develop strategies tailored to this group's unique experiences and challenges.

Inclusion Criteria

Self-identify as Black or African American
Speak and read English
I am 55 years old or older.
See 1 more

Exclusion Criteria

Unstable medical/psychiatric condition that in the opinion of the PI could impact study participation
My mental ability to understand and participate is not impaired.
I have a physical condition that makes it hard for me to be physically active.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants collaborate to design strategies to reduce sedentary behavior using the C2DREAM model

8 weeks
Weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for changes in sedentary behavior and cardiometabolic risk markers

4 weeks
2 visits (in-person)

Treatment Details

Interventions

  • Collaborative Solutions for Breaking up Sedentary Time
Trial Overview The study is testing personalized strategies designed collaboratively with participants to break up long periods of sitting or lying down, which can be harmful to health. It focuses on the relationship between sedentary behavior and various personal and societal factors.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Experimental groupExperimental Treatment1 Intervention
Black adults aged 55 and older with T2D

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Findings from Research

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.
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]
The randomized controlled trial (RCT) involving 71 young adults at high risk for type 2 diabetes found no significant reduction in sedentary behavior after a 12-month intervention, despite positive feedback on the educational workshops.
Barriers to reducing sedentary time included a lack of perceived health risk, preference for active behaviors, motivational drift after initial follow-ups, and issues with the self-monitoring tool, suggesting that future interventions should enhance participant engagement and address these challenges.
Reducing sedentary time in adults at risk of type 2 diabetes: process evaluation of the STAND (Sedentary Time ANd Diabetes) RCT.Biddle, SJ., Edwardson, CL., Gorely, T., et al.[2021]
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.
Sedentary Behavior Counseling Intervention in Aging People With Type 2 Diabetes: A Feasibility Study.Alothman, S., Alenazi, AM., Alshehri, MM., et al.[2021]

References

The effects of a pedometer-based behavioral modification program with telephone support on physical activity and sedentary behavior in type 2 diabetes patients. [2022]
Reducing sedentary time in adults at risk of type 2 diabetes: process evaluation of the STAND (Sedentary Time ANd Diabetes) RCT. [2021]
Sedentary Behavior Counseling Intervention in Aging People With Type 2 Diabetes: A Feasibility Study. [2021]
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]
Sitting Less and Moving More: Improved Glycaemic Control for Type 2 Diabetes Prevention and Management. [2023]
A Standardised Core Outcome Set for Measurement and Reporting Sedentary Behaviour Interventional Research: The CROSBI Consensus Study. [2022]
Multicomponent intervention to reduce daily sedentary time: a randomised controlled trial. [2022]
Sedentary behaviour as a new behavioural target in the prevention and treatment of type 2 diabetes. [2018]
Rationale and study design for a randomised controlled trial to reduce sedentary time in adults at risk of type 2 diabetes mellitus: project stand (Sedentary Time ANd diabetes). [2022]
Type 2 diabetes sits in a chair. [2018]
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