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Active, not recruitingNCT03511352Updated Jun 14, 2024

Sedentary Behavior Interrupted: A Trial of Acute Effects on Biomarkers of Healthy Aging

An interventional study of Frequent sit-to-stands and Stand More in Sedentary Lifestyle, sponsored by University of California, San Diego. Active, not recruiting at 1 site in United States. Open to female participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-14.

Sponsored by University of California, San Diego · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
55 Years and older
Sex
Female
01

Study 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). 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.

02

Conditions studied

  • Sedentary Lifestyle
03

In context

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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);
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
78 participants (estimated)

Study arms

  • No intervention
    Control Condition (Protocol A)

    Following a one-hour sitting run-in period, participants will sit for a 5-hour period including a mid-point bathroom break.

  • Experimental
    Frequent Sit-to-Stands (Protocol B)

    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.

    Behavioral: Frequent sit-to-stands

  • Experimental
    Stand More (Protocol C)

    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.

    Behavioral: Stand More

Interventions

  • BehavioralFrequent sit-to-stands

    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.

    Also known as: Protocol B

  • BehavioralStand More

    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.

    Also known as: Protocol C

06

What researchers measure

Primary outcomes

  1. Postprandial glucose

    To investigate the acute effect of sitting interruption modalities on postprandial glucose compared to prolonged sitting.

    Time frame: 5 hours

  2. Insulin

    To investigate the acute effect of sitting interruption modalities on insulin concentrations compared to prolonged sitting.

    Time frame: 5 hours

Secondary outcomes

  1. Flow mediated dilation

    To investigate the acute effect of sitting interruption modalities on flow mediated dilation compared to prolonged sitting

    Time frame: 5 hours

  2. Blood pressure

    To investigate the acute effect of sitting interruption modalities on blood pressure compared to prolonged sitting.

    Time frame: 5 hours

07

Study locations

1 site
  • UC San Diego
    La Jolla, California 92093, United States
08

References and documents

Study documents

  • Informed consent form · Jun 13, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03511352
Lead sponsor
University of California, San Diego
Responsible party
Dorothy Sears (Associate Professor, University of California, San Diego) — Principal investigator
First posted
Apr 27, 2018
Start date
May 8, 2018
Primary completion
Apr 30, 2024
Completion
Dec 31, 2024 (estimated)
Last update
Jun 14, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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