Clinical trial NCT06283849: Collaborative Solutions for Breaking up Sedentary Time in Black Older Adults With Type 2 Diabetes: The Interrupt Diabetes Study
Official title: Collaborative Solutions for Breaking up Sedentary Time in Black Older Adults With Type 2 Diabetes: The Interrupt Diabetes Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cardiovascular Diseases
Type 2 Diabetes
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Explanatory sequential mixed methods study of N=30 Black adults aged 55 and older with T2D.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Self-identify as Black or African American.
* Aged 55 years and older.
* Speak and read English.
* Self-reported diagnosis of T2D.

Exclusion Criteria:

* Evidence of cognitive impairment that could impact ability to consent and/or participation (Mini-Cog score \<3).
* Physical impairment or disability that interferes with ability to engage in PA (e.g., severe osteoarthritis, lower extremity amputation \[other than toe(s)/partial foot\], regular use of a walker or wheelchair, etc.).
* Unstable medical/psychiatric condition that in the opinion of the PI could impact study participation.

Primary outcomes:
measure: sedentary time
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Mary O Whipple, PhD, RN, PHN
role: PRINCIPAL_INVESTIGATOR
References: