Cardiovascular DiseasesPhase 2NCT06283849
Collaborative Solutions for Breaking up Sedentary Time in Black Older Adults With Type 2 Diabetes: The Interrupt Diabetes Study
A Phase 2 study testing strategies to break up SB in people with Cardiovascular Diseases and Type 2 Diabetes, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Cardiovascular Diseases, Type 2 Diabetes
- What is being tested?
- strategies to break up SB
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 20 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identify as Black or African American.
- Aged 55 years and older.
- Speak and read English.
- Self-reported diagnosis of T2D.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
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.
Read more
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.
- Conditions
- Cardiovascular Diseases, Type 2 Diabetes
- Being tested
- strategies to break up SB
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strategies to break up SBBehavioural
Participants will be asked to implement strategies to break up their SB every hour for at least 8 hours a day for one week. Strategies will be developed through collaboration with participants during the first study interview and may include (but are not limited to): calf raises, brief (~5 min) self-paced walking), squats, sit to stand, etc. Participants will wear an activity monitor for assessment of SB and walking. This device (activPAL, PALTechnologies, Glasgow, Scotland) is not an investigational device; it is used for monitoring sedentary behavior.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Black adults aged 55 and older with T2D Receives: Behavioral: strategies to break up SB |
What is being measured
The primary outcome is the main question the study is designed to answer.
sedentary time
measured via accelerometer
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 May 2024
- Primary completion20 Nov 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Explanatory sequential mixed methods study of N=30 Black adults aged 55 and older with T2D.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary O Whipple, PhD, RN, PHN, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283849
- Sponsor's protocol ID
- SON-2024-32671
- Status last verified
- Feb 2026
- First submitted
- 21 Feb 2024
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Solutions for Breaking up Sedentary Time in Black Older Adults With Type 2 Diabetes: The Interrupt Diabetes Study
- ClinicalTrials.gov ID
- NCT06283849
- Acronym / sponsor ID
- SON-2024-32671
- Conditions
- Cardiovascular Diseases, Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Explanatory sequential mixed methods study of N=30 Black adults aged 55 and older with T2D.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: strategies to break up SBBlack adults aged 55 and older with T2D |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-identify as Black or African American.
- Aged 55 years and older.
- Speak and read English.
- Self-reported diagnosis of T2D.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| strategies to break up SBParticipants will be asked to implement strategies to break up their SB every hour for at least 8 hours a day for one week. Strategies will be developed through collaboration with participants during the first study interview and may include (but are not limited to): calf raises, brief (~5 min) self-paced walking), squats, sit to stand, etc. Participants will wear an activity monitor for assessment of SB and walking. This device (activPAL, PALTechnologies, Glasgow, Scotland) is not an investigational device; it is used for monitoring sedentary behavior. | Behavioural | Experimental group |
Primary outcome
sedentary time
Time frame: 7 days
measured via accelerometer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary O Whipple, PhD, RN, PHN principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing strategies to break up SB in people with Cardiovascular Diseases and Type 2 Diabetes, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sedentary time (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.