AzTrials
AzTrials

Sedentary LifestyleNCT02743286

Sedentary Behavior Interrupted - A Pilot Study of Acute Interventions on Prolonged Sitting

A study testing Frequent sit-to-stands, Walking breaks and Stand more in people with Sedentary Lifestyle, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Sedentary behavior, characterized by excess sitting time during waking hours, is detrimental to health and increases cardiometabolic disease risk, independent of moderate-to-vigorous physical activity. 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, Walking breaks and Stand more
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Apr 2016to Jul 2016
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

  • Postmenopausal woman, any ethnicity/race, 55+ years of age.
  • Ambulatory, medically stable, able to give informed consent, and safely complete the protocols.
  • Fluent in the English language.
  • Body Mass Index range of 27-45kg/m2.
  • Sedentary: Average ≥6hr sitting time, and <20min physical activity on 3 or more days per week, as assessed by self report.

Who cannot join

  • Mental states that would preclude complete understanding of the protocol and compliance.
  • Chronic illness that may be associated with weight change (HIV/AIDS, active cancer, or uncontrolled thyroid disease).
  • Body Mass Index <27 or >45kg/m2.
  • Anemia (hemoglobin ≤11g/dL) - determined by CBC test done at screening.
  • Arthritis or degenerative joint disease affecting knees where repeated sitting/standing interruptions might cause pain.
  • Personal or family history of venous thrombosis.
Show all 16Show fewer
  • Type 1 diabetes mellitus
  • Poorly controlled hypertension (SBP ≥165 or DBP ≥100).
  • Weight instability in past 3 months (no more than 5% up or down).
  • Participants <65 years of age with HbA1c ≥53 mmol/mol (7%) and participants ≥65 years of age with HbA1c ≥58mmol/mol (7.5%) will be excluded for uncontrolled diabetes.34,35
  • Use of insulin medications.
  • 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).
  • Use of any immunosuppressant or corticosteroid medication.
  • Use of medications that might cause weight change (e.g., second generation anti-psychotics).
  • < 6hr average daily sitting time.
  • 17) ≥20min physical activity average on 3 or more days per week 18) Participating in another clinical trial. 19) Blood donation less than 56 days prior to screening visit. 20) Smoking cigarettes or anything, and other use of tobacco products.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, San Diego

    La Jolla, California, 92093

Other trials in United States

About this study

Sedentary behavior, characterized by excess sitting time during waking hours, is detrimental to health and increases cardiometabolic disease risk, independent of moderate-to-vigorous physical activity. The mechanisms that mediate this are unknown and there are no evidence-based methods known for effectively intervening on sedentary behavior. The consequences of prolonged sitting time are of particular interest in older adults as sedentary behavior and cardiometabolic disease risk both increase with aging and moderate-to-vigorous physical activity may not be feasible. This pilot study will assess interventions for sedentary older adults designed to interrupt prolonged sitting time. Interrupting sitting time through sit-to-stand transitions, and standing and walking breaks increases muscle use and blood flow in the lower parts of the body. Thus, the investigators believe that frequent sit-to-stand interruptions of sitting time are the most efficacious sedentary behavior interventions, compared to simply reducing sitting time or less frequent walking breaks, for improving health outcomes and healthy aging. The investigators hypothesize that frequency of sit-to-stands during a 5-hour sitting period will result in health benefits that can be observed with a simple 2-minute standing interruption, and that this will be associated with improvements in metabolism and endothelial function. This pilot, 10-participant study will 1) generate preliminary data for a revised Program Project Grant application to the National Institute of Aging (NIA) that focuses on postmenopausal women, the fastest growing aged population with high life-time risk of cardiometabolic risk. This pilot study will inform sitting interruption modality design for two projects in the investigators' Program Project Grant application: "Project 1: Sedentary Behavior Interrupted: A randomized crossover treatment trial of acute effects on biomarkers of healthy aging in the laboratory (86 participants)" and "Project 2: Sedentary Behavior Interrupted: A randomized trial of 6 month effects on biomarkers of healthy aging and physical functioning in the real world (660 participants)." The current design of this pilot study is enhanced by and responsive to feedback from our initial NIA submission. This pilot study will increase our knowledge about how sedentary behavior and sitting interruption interventions influence healthy aging in postmenopausal women.

Read the detailed description

Sedentary behavior, characterized by excess sitting time during waking hours, is detrimental to health and increases cardiometabolic disease (e.g., type 2 diabetes) risk, independent of moderate-to-vigorous physical activity. The mechanisms that mediate this are unknown and there are no evidence-based methods known for effectively intervening on sedentary behavior. The consequences of prolonged sitting time are of particular interest in older adults as sedentary behavior and cardiometabolic disease risk both increase with aging and moderate-to-vigorous physical activity may not be feasible. The investigators propose pilot and feasibility testing of interventions for sedentary older adults that are designed to interrupt prolonged sitting time. Interrupting sitting time through sit-to-stand transitions, and standing and walking breaks increases muscle use and blood flow in the lower parts of the body. Thus, the investigators believe that frequent sit-to-stand interruptions of sitting time are the most efficacious sedentary behavior interventions, compared to simply reducing sitting time or less frequent walking breaks, for improving health outcomes and healthy aging. The investigators hypothesize that frequent sit-to-stands during a 5-hour sitting period will result in health benefits that can be observed with a simple 2-minute standing interruption, and that this will be associated with improvements in metabolism and endothelial function. This pilot, 10-participant study will 1) generate preliminary data for a revised Program Project Grant application to the National Institute of Aging (NIA) that focuses on postmenopausal women, the fastest growing aged population with high life-time risk of cardiometabolic risk. This pilot study will inform sitting interruption modality design for two projects in the investigators' Program Project Grant application: "Project 1: Sedentary Behavior Interrupted: A randomized crossover treatment trial of acute effects on biomarkers of healthy aging in the laboratory (86 participants)" and "Project 2: Sedentary Behavior Interrupted: A randomized trial of 6 month effects on biomarkers of healthy aging and physical functioning in the real world (660 participants)." The current design of this pilot study is enhanced by and responsive to feedback from our initial NIA submission. This pilot study will increase our knowledge about how sedentary behavior and sitting interruption interventions influence healthy aging in postmenopausal women.

SPECIFIC AIM The deleterious health consequences of too much sitting are independent of moderate-to-vigorous physical activity. Understanding the health consequences of sitting time is particularly relevant for older adults who are extremely sedentary and at high risk of several chronic diseases that have been linked with sitting time, including type 2 diabetes. Interestingly, sedentary behavior is least studied among older adults who may benefit the most from reducing sitting time. Reducing uninterrupted sitting time in older adults is a research priority because the pervasiveness of sitting time, typically >8 hours per day, provides many opportunities for intervention. Specific interventions are required to reduce sitting because it is such a habitual behavior and is reinforced by social norms and chair-dominant contexts.

In this pilot study, the investigators focus on three different types of prolonged sitting interruptions as variables. Studies have shown that frequent breaks in sitting may reduce risk for cardiometabolic disease. In older adults, the investigators anticipate that frequent sit-to-stand transitions will impact metabolic, inflammatory and other biomarkers, in particular those related to mitochondrial and endothelial function. A key limitation of previous sedentary intervention studies is that they have not impacted frequency of sit-to-stand transitions; rather, they decreased total sitting and increased standing time. Further, previous sedentary intervention studies have not directly compared frequent sit-to-stand transition interruptions with other interruption modalities associated with less frequent sit-to-stand transitions, for example, reduced overall sitting time (standing more) or with occasional walking breaks. The investigators propose to test these sedentary behavior interruptions modalities to disrupt prolonged sitting and explore mitochondrial- and endothelial function-based mechanisms of action. Biologic theories suggest that interrupting sitting via sit-to-stand muscle contraction and increased blood flow to extremities is key to improving in healthy aging outcomes.

In a controlled laboratory study of prolonged sitting, 3 different interruption break types will be utilized. Ten sedentary, postmenopausal participants 55+ years of age and body mass index (BMI) of 27-45 will be enrolled. After screening and enrollment, participants will visit the clinic on 4 occasions for a 6-hour monitoring period and, following a 1-hour sitting run-in period, complete each of 4 5-hour sitting protocols. The 3 sitting interruption protocols will each include sitting interruptions of different break frequency and type and will allow evaluation of the effect of sit-to-stand transitions and interruption type on acute metabolism and health outcomes. All study protocols include baseline, mid-point, and end-of-study bathroom breaks for urine sample collection with additional bathroom breaks allowed as needed. During each protocol at multiple time points, blood samples will be collected to assess changes in biomarkers of glycemic regulation (glucose and insulin areas under the curve) and mitochondrial function over the course of the sitting protocols. During each protocol at multiple time points, changes in endothelial function, specifically, blood pressure (indirect measure) and femoral flow-mediated dilation (direct measure), will be assessed. Changes in these measures will be compared between protocols. A small aliquot (0.5mL) of plasma samples and urine samples collected during the protocol will be banked for possible ancillary, exploratory studies. This study is a crossover design and each participant will be her own control. The investigators hypothesize that frequent sit-to-stands during a 5-hour sitting period will result in health benefits that can be observed with a simple 2-minute standing interruption, and that this will be associated with improvements in metabolism and endothelial function. The investigators will test this hypothesis in the following aim:

Study Aim: Using a randomized, controlled crossover study design, assess the feasibility and metabolic and endothelial function outcomes of an acute bout of prolonged sitting ± standing or walking interruptions using targeted metabolic and endothelial function biomarker analyses.

Being tested
Frequent sit-to-stands, Walking breaks, Stand more
Keywords
sedentary behavior, sitting, feasibility, endothelial function, metabolism
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 15 2-minute standing interruptions, 3 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.

  • Walking breaksBehavioural

    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 2-minute walking interruptions, 3 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.

  • Stand moreBehavioural

    Also called Protocol D

    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 10-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 groups in NCT02743286
Study groupRoleWhat they receive
Control condition (Protocol A)No interventionFollowing 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)ExperimentalFollowing a 1-hour sitting run-in period, participants will sit for a 5-hour period including 15 2-minute standing interruptions, 3 per hour, and a mid-point bathroom break.
Receives: Behavioral: Frequent sit-to-stands
Walking breaks (Protocol C)ExperimentalFollowing a 1-hour sitting run-in period, participants will sit for a 5-hour period including 5 2-minute walking interruptions, 3 per hour, and a mid-point bathroom break.
Receives: Behavioral: Walking breaks
Stand More (Protocol D)ExperimentalFollowing a 1-hour sitting run-in period, participants will sit for a 5-hour period including 5 10-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.

  1. Change in endothelial function

    Change in endothelial function will be assessed by femoral flow-mediated dilation (FMD) and blood pressure measurements collected during the course of each study visit condition. Intervention-induced change will be compared to change observed during the control condition.

    Measured: Five hours

  2. Change in glycemic regulation

    Change in glycemic regulation will be assessed by measuring plasma glucose and insulin concentrations in blood collected at 30-min intervals during each study visit condition. Intervention-induced change will be compared to change observed during the control condition.

    Measured: Five hours

Secondary outcomes (2)
  1. Study feasibility

    Feasibility will be assess by tabulating the following: number of recruitment inquiries, number of participants screened at clinic, number of participants enrolled, number of participants completing all protocols, and acceptability of sitting protocols to participants.

    Measured: 3 months

  2. Change in mitochondrial metabolites

    Change in mitochondrial metabolites will be assessed by mass spectrometry measurements of plasma samples collected at the beginning and end of each study visit condition. Intervention-induced change will be compared to change observed during the control condition.

    Measured: Five hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

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
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02743286
Sponsor's protocol ID
150509
Status last verified
Sep 2016
First submitted
30 Mar 2016
Last updated
8 Sep 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Kerr J, Crist K, Vital DG, Dillon L, Aden SA, Trivedi M, Castellanos LR, Godbole S, Li H, Allison MA, Khemlina GL, Takemoto ML, Schenk S, Sallis JF, Grace M, Dunstan DW, Natarajan L, LaCroix AZ, Sears DD. Acute glucoregulatory and vascular outcomes of three strategies for interrupting prolonged sitting time in postmenopausal women: A pilot, laboratory-based, randomized, controlled, 4-condition, 4-period crossover trial. PLoS One. 2017 Nov 30;12(11):e0188544. doi: 10.1371/journal.pone.0188544. eCollection 2017.

    PubMed 29190761

Questions about this trial

What is this clinical trial studying?

A study testing Frequent sit-to-stands, Walking breaks 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 5 inclusion and 16 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 8 Sep 2016. 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?

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?

Change in endothelial function (time frame: Five 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?

On the ClinicalTrials.gov record for NCT02743286, which also lists 1 linked publication.

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 8 Sep 2016.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in