Sedentary LifestyleNCT03511352
Sedentary Behavior Interrupted: A Trial of Acute Effects on Biomarkers of Healthy Aging
A study testing Frequent sit-to-stands and Stand More in people with Sedentary Lifestyle, run by University of California, San Diego at 1 site in United States.
Trial summary
This protocol "Sedentary Behavior Interrupted: A randomized crossover trial of acute effects on biomarkers of healthy aging in the laboratory (Project 1)" is part of a National Institutes of Aging Program Grant called "Sedentary Time \& Aging Mortality and Physical Function (STAR). Read more about this study
- Who is it for?
- Ages 55 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Frequent sit-to-stands and Stand More
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2018to 31 Dec 2024
- Phase
- Interventional
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female
- 55 years of age and above
- any ethnicity or race
- screened to sit for 8 or more hours per day, perform less than 60 sit-to-stand transitions per day \& engage in less than 20 minutes of moderate-to-vigorous physical activity (MVPA) per day
- BMI 25 - 45 kg/m2
- ambulatory
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- medically stable without any health conditions that would inhibit standing or PA;
- able to give informed consent \& comply with study protocols;
- able to read, communicate, and write fluently in English;
- able to travel to study visits;
- no menstruation for at least one year;
- not participating or not planning to participate in a physical activity or weight loss program or research study.
Who cannot join
- Mental state that would preclude complete understanding of the protocol or compliance;
- type 1 diabetes;
- type 2 diabetes using insulin or with poor glycemic control (greater than 10% for all participants);
- poorly controlled hypertension (Systolic Blood Pressure ≥165 or Diastolic Blood Pressure ≥100);
- chronic illness that may be associated with weight change (HIV/AIDS, active cancer, or uncontrolled thyroid disease),
- anemia (hemoglobin ≤11g/dL);
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- personal or first-degree relative history of venous thrombosis;
- weight instability in past 3 months (no more than 5% up or down);
- regular use of vasodilator medication and high risk of stroke and/or heart attack (i.e., history of multiple hospitalizations (>2X) in the last 6 months), congestive heart failure, atrial fibrillation, and/or stroke;
- regular use of immunosuppressant or corticosteroid medication;
- blood donation less than 56 days prior to screening visit,
- smoking cigarettes or smoking or ingesting anything, and other use of tobacco products including e-cigarettes.
- diagnosis of orthostatic hypotension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sedentary Behavior Interrupted: A Randomized Crossover Trial of Acute Effects on Biomarkers of Healthy Aging in the Laboratory (Project 1)
This protocol "Sedentary Behavior Interrupted: A randomized crossover trial of acute effects on biomarkers of healthy aging in the laboratory (Project 1)" is part of a National Institutes of Aging Program Grant called "Sedentary Time \& Aging Mortality and Physical Function (STAR). The overall purpose of the STAR program to is to better understand how to interrupt sitting time and the consequences for healthy aging in postmenopausal women. This protocol (also referred to Project 1 of the STAR program) is a 3-condition randomized crossover clinical trial of up to 86 postmenopausal women to test whether different interruptions to prolonged sitting improve metabolism.
Read the detailed description
The specific aims of this protocol include:
Aim 1. To investigate the acute effect of sitting interruption modalities on postprandial glucose and insulin concentrations, compared to prolonged sitting.
Aim 2. To investigate the acute effect of sitting interruption modalities on the physiologic parameters of endothelial function, compared to prolong sitting.
Aim 3. To explore the moderating effect of age.
- Conditions
- Sedentary Lifestyle
- Being tested
- Frequent sit-to-stands, Stand More
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequent sit-to-standsBehavioural
Also called Protocol B
Participants will visit the clinic for a 6-hour monitoring period. Following a 1-hour sitting run-in period, participants will sit for an additional 5-hour period including a 2-min stand every 15 min throughout the 5-hr protocol period. Baseline, mid-point, and end-of-visit bathroom breaks for urine sample collection will be conducted, with additional bathroom breaks allowed as needed.
Stand MoreBehavioural
Also called Protocol C
Participants will visit the clinic for a 6-hour monitoring period. Following a 1-hour sitting run-in period, participants will sit for an additional 5-hour period including 5 8-minute standing interruptions, 1 per hour. Baseline, mid-point, and end-of-visit bathroom breaks for urine sample collection will be conducted, with additional bathroom breaks allowed as needed.
| Study group | Role | What they receive |
|---|---|---|
| Control Condition (Protocol A) | No intervention | Following a one-hour sitting run-in period, participants will sit for a 5-hour period including a mid-point bathroom break. |
| Frequent Sit-to-Stands (Protocol B) | Experimental | Following a 1-hour sitting run-in period, participants will sit for a 5-hour period including a 2-min stand every 15 min throughout the 5-hr protocol period and a mid-point bathroom break. Receives: Behavioral: Frequent sit-to-stands |
| Stand More (Protocol C) | Experimental | Following a 1-hour sitting run-in period, participants will sit for a 5-hour period including 5 8-minute standing breaks, 1 per hour, and a mid-point bathroom break. Receives: Behavioral: Stand More |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucose
To investigate the acute effect of sitting interruption modalities on postprandial glucose compared to prolonged sitting.
Measured: 5 hours
Insulin
To investigate the acute effect of sitting interruption modalities on insulin concentrations compared to prolonged sitting.
Measured: 5 hours
Secondary outcomes (2)
Flow mediated dilation
To investigate the acute effect of sitting interruption modalities on flow mediated dilation compared to prolonged sitting
Measured: 5 hours
Blood pressure
To investigate the acute effect of sitting interruption modalities on blood pressure compared to prolonged sitting.
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start8 May 2018
- Primary completion30 Apr 2024
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorothy Sears, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511352
- Sponsor's protocol ID
- 171547
- Status last verified
- Jun 2024
- First submitted
- 26 Mar 2018
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedentary Behavior Interrupted: A Randomized Crossover Trial of Acute Effects on Biomarkers of Healthy Aging in the Laboratory (Project 1)
- ClinicalTrials.gov ID
- NCT03511352
- Acronym / sponsor ID
- 171547
- Conditions
- Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 8 May 2018 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Apr 2018 (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.
This protocol "Sedentary Behavior Interrupted: A randomized crossover trial of acute effects on biomarkers of healthy aging in the laboratory (Project 1)" is part of a National Institutes of Aging Program Grant called "Sedentary Time \& Aging Mortality and Physical Function (STAR). The overall purpose of the STAR program to is to better understand how to interrupt sitting time and the consequences for healthy aging in postmenopausal women. This protocol (also referred to Project 1 of the STAR program) is a 3-condition randomized crossover clinical trial of up to 86 postmenopausal women to test whether different interruptions to prolonged sitting improve metabolism.
Detailed description
The specific aims of this protocol include:
Aim 1. To investigate the acute effect of sitting interruption modalities on postprandial glucose and insulin concentrations, compared to prolonged sitting.
Aim 2. To investigate the acute effect of sitting interruption modalities on the physiologic parameters of endothelial function, compared to prolong sitting.
Aim 3. To explore the moderating effect of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Condition (Protocol A) | No intervention | –Following a one-hour sitting run-in period, participants will sit for a 5-hour period including a mid-point bathroom break. |
| Frequent Sit-to-Stands (Protocol B) | Experimental | Behavioral: Frequent sit-to-standsFollowing a 1-hour sitting run-in period, participants will sit for a 5-hour period including a 2-min stand every 15 min throughout the 5-hr protocol period and a mid-point bathroom break. |
| Stand More (Protocol C) | Experimental | Behavioral: Stand MoreFollowing a 1-hour sitting run-in period, participants will sit for a 5-hour period including 5 8-minute standing breaks, 1 per hour, and a mid-point bathroom break. |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- female
- 55 years of age and above
- any ethnicity or race
- screened to sit for 8 or more hours per day, perform less than 60 sit-to-stand transitions per day \& engage in less than 20 minutes of moderate-to-vigorous physical activity (MVPA) per day
- BMI 25 - 45 kg/m2
Key exclusion criteria (13 listed)
- Mental state that would preclude complete understanding of the protocol or compliance;
- type 1 diabetes;
- type 2 diabetes using insulin or with poor glycemic control (greater than 10% for all participants);
- poorly controlled hypertension (Systolic Blood Pressure ≥165 or Diastolic Blood Pressure ≥100);
- chronic illness that may be associated with weight change (HIV/AIDS, active cancer, or uncontrolled thyroid disease),
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 |
|---|---|---|
| Frequent sit-to-standsAlso: Protocol BParticipants will visit the clinic for a 6-hour monitoring period. Following a 1-hour sitting run-in period, participants will sit for an additional 5-hour period including a 2-min stand every 15 min throughout the 5-hr protocol period. Baseline, mid-point, and end-of-visit bathroom breaks for urine sample collection will be conducted, with additional bathroom breaks allowed as needed. | Behavioural | Frequent Sit-to-Stands (Protocol B) |
| Stand MoreAlso: Protocol CParticipants will visit the clinic for a 6-hour monitoring period. Following a 1-hour sitting run-in period, participants will sit for an additional 5-hour period including 5 8-minute standing interruptions, 1 per hour. Baseline, mid-point, and end-of-visit bathroom breaks for urine sample collection will be conducted, with additional bathroom breaks allowed as needed. | Behavioural | Stand More (Protocol C) |
Primary outcome
Postprandial glucose
Time frame: 5 hours
To investigate the acute effect of sitting interruption modalities on postprandial glucose compared to prolonged sitting.
Insulin
Time frame: 5 hours
To investigate the acute effect of sitting interruption modalities on insulin concentrations compared to prolonged sitting.
2 secondary outcomes
Flow mediated dilation
Time frame: 5 hours
Blood pressure
Time frame: 5 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frequent sit-to-stands and Stand More in people with Sedentary Lifestyle, run by University of California, San Diego 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 12 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 14 Jun 2024. 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.
Are results available for this study?
Results are not available in the source record.
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?
Postprandial glucose (time frame: 5 hours). The study lists 2 primary outcomes in all. 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 14 Jun 2024.