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

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ClinicalTrials.gov Identifier: NCT03511352
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Dorothy Sears, University of California, San Diego

Brief 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.

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Behavioral: Frequent sit-to-stands Behavioral: Stand More Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Sedentary Behavior Interrupted: A Randomized Crossover Trial of Acute Effects on Biomarkers of Healthy Aging in the Laboratory (Project 1)
Actual Study Start Date : May 8, 2018
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.
Other Name: Protocol B

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
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.
Other Name: Protocol C




Primary Outcome Measures :
  1. Postprandial glucose [ Time Frame: 5 hours ]
    To investigate the acute effect of sitting interruption modalities on postprandial glucose compared to prolonged sitting.

  2. Insulin [ Time Frame: 5 hours ]
    To investigate the acute effect of sitting interruption modalities on insulin concentrations compared to prolonged sitting.


Secondary Outcome Measures :
  1. Flow mediated dilation [ Time Frame: 5 hours ]
    To investigate the acute effect of sitting interruption modalities on flow mediated dilation compared to prolonged sitting

  2. Blood pressure [ Time Frame: 5 hours ]
    To investigate the acute effect of sitting interruption modalities on blood pressure compared to prolonged sitting.



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511352


Contacts
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Contact: Lindsay Dillon 8585349329 ldillon@ucsd.edu

Locations
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United States, California
UC San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Brittany Lewars, MPH    858-534-9333    blewars@ucsd.edu   
Contact: Lindsay Dillon, MPH    8585349329    ldillon@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego

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Responsible Party: Dorothy Sears, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03511352     History of Changes
Other Study ID Numbers: 171547
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No