Strategies to Reduce Sedentary Time for Type 2 Diabetes

Overseen By Mary O Whipple, PhD, RN, PHN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Minnesota

Disqualifiers: Cognitive impairment, Physical impairment, Unstable condition

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop strategies to reduce sedentary behavior (sitting for long periods) in Black adults aged 55 and older with Type 2 Diabetes (T2D). The research focuses on understanding how sitting affects health and finding ways to encourage more movement, which can improve heart health and better manage diabetes. Participants will collaborate using Collaborative Solutions for Breaking up Sedentary Time to identify and try different methods to interrupt prolonged sitting. The trial specifically seeks Black adults with T2D who are interested in exploring new ways to be more active in their daily lives. As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group, offering participants a chance to contribute to potentially impactful health solutions.

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 prior data suggests that these strategies to reduce sedentary time are safe for Black adults with Type 2 Diabetes?

Research shows that taking breaks from long periods of sitting benefits health. Lab studies have found that standing up and moving around quickly improves blood sugar levels and heart health. This approach is generally safe and easy to implement.

Less information exists on how this method specifically affects Black adults with type 2 diabetes. However, past studies have not raised major safety concerns about the general idea of moving more and sitting less. Since this trial is in an early stage, it primarily focuses on assessing the method's safety and effectiveness.

In summary, while more research is needed for this specific group, current evidence suggests that taking breaks from sitting is likely safe and may offer health benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Collaborative Solutions for Breaking up Sedentary Time" approach because it offers a fresh way to tackle Type 2 Diabetes (T2D) by focusing on reducing sedentary behavior, especially for Black adults aged 55 and older. Unlike standard treatments that usually involve medication or diet changes, this method emphasizes breaking up long periods of sitting with active movement. This behavioral strategy could lead to more sustainable lifestyle changes and potentially improve blood sugar control without relying solely on medication. By targeting sedentary habits directly, this approach hopes to address a significant but often overlooked factor in managing T2D.

What evidence suggests that this trial's strategies could be effective for reducing sedentary time in Black adults with Type 2 Diabetes?

Research shows that taking breaks from long periods of sitting can quickly improve health markers related to type 2 diabetes, such as blood sugar levels and blood vessel health. Studies have found that reducing daily sitting time can help manage type 2 diabetes by enhancing blood sugar control. Even short breaks from sitting can improve heart and metabolic health, which are crucial for people with type 2 diabetes. Programs that focus on reducing sitting time encourage more active lifestyles, leading to healthier outcomes. In this trial, participants will engage in "Collaborative Solutions for Breaking up Sedentary Time," which involves working together on plans and strategies to reduce sitting time and increase physical activity. ^{1 2 6 7 8}

Who Is on the Research Team?

Mary O Whipple, PhD, RN, PHN

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Experimental group Experimental Treatment 1 Intervention

Black adults aged 55 and older with T2D

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

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]

Increased sedentary time, or 'sitting time', is a significant factor in the development and worsening of type 2 diabetes (T2D), highlighting the need for effective prevention strategies.

The review raises the question of whether reducing sitting time could serve as a beneficial treatment for T2D, suggesting that lifestyle changes may play a crucial role in managing the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type 2 diabetes sits in a chair. Solomon, TP., Thyfault, JP.[2018]

The multicomponent technology intervention significantly reduced daily sedentary time by an average of 58.7 minutes per day among 40 overweight university employees over a 12-week period, indicating its efficacy in promoting physical activity.

Participants engaged well with the intervention, using the provided tools like the pedal machine and online program, which suggests that such technology-based approaches could be effective in reducing sedentary behavior in workplace settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicomponent intervention to reduce daily sedentary time: a randomised controlled trial. Carr, LJ., Karvinen, K., Peavler, M., et al.[2022]

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]

The Core Research Outcomes for Sedentary Behaviour Interventions (CROSBI) study established a standardized core outcome set (COS v1.0) consisting of 53 data items across 12 domains to improve the consistency of reporting in sedentary behavior research.

The consensus emphasizes the importance of using devices that measure posture and sedentary behavior accurately, which will help enhance the quality and comparability of future intervention studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Standardised Core Outcome Set for Measurement and Reporting Sedentary Behaviour Interventional Research: The CROSBI Consensus Study. Curran, F., Dowd, KP., Peiris, CL., 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]

Project STAND is a randomized controlled trial aimed at reducing sedentary behavior in younger adults (ages 18-40) at high risk for Type 2 Diabetes Mellitus (T2DM), involving 178 participants split between intervention and control groups.

The primary outcome of the study is to measure the reduction in sedentary behavior over 12 months using accelerometers, with secondary outcomes including various health metrics like physical activity levels, glucose tolerance, and body weight, which will help inform future interventions for this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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). Wilmot, EG., Davies, MJ., Edwardson, CL., et al.[2022]

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. withpower.com withpower.com/trial/phase-2-cardiovascular-diseases-4-2024-59347

Strategies to Reduce 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 ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06283849/collaborative-solutions-for-breaking-up-sedentary-time-in-black-older-adults-with-type-2-diabetes-the-interrupt-diabetes-study

The Interrupt Diabetes Study | Clinical Research Trial Listing Experimental data from lab-based studies demonstrate that breaking up prolonged SB can rapidly improve markers of cardiometabolic risk (e.g., ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9331801/

Health effects of reduced occupational sedentary behaviour in ... The aim of this study is to evaluate the effects of a mHealth intervention on sedentary behaviour and physical activity and the associated changes in health in ...

4. journals.plos.org journals.plos.org/plosone/article/file?type=printable&id=10.1371/journal.pone.0330393

Quasi-experimental controlled study protocol to reduce ... The general objective of the study is to know the effect of decreasing sedentary time and increasing motivation to adopt an active lifestyle of ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0277953621006687

Can individual, dyadic, or collaborative planning reduce ... Collaborative planning may prompt a short-term reduction of SB time and result in a shift towards a healthier balance between SB time and PA time among target ...

6. ijclinicaltrials.com ijclinicaltrials.com/index.php/ijct/article/view/632

Breaking up sedentary time to improve glucose control in a ... Primary outcomes will be daily glycemic mean and variability, fasting glucose and HbA1c, postprandial plasma glucose and insulin, glucose kinetics, and content ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04142346

Breaking-up Sedentary Time and 2 Weeks Detraining Regularly interrupting sedentary behavior (SB) with activity breaks may attenuate postprandial glucose (PPG) excursions and improve glycemic control.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6985064/

Effects of Interrupting Prolonged Sitting with Physical Activity ... Physical activity (PA) breaks in sitting time might attenuate metabolic markers relevant to the prevention of type 2 diabetes. The primary aim of this paper ...