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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 : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Dorothy Sears, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE March 26, 2018
First Posted Date  ICMJE April 27, 2018
Last Update Posted Date November 3, 2020
Actual Study Start Date  ICMJE May 8, 2018
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2018)
  • Change in postprandial glucose [ Time Frame: 5 hours ]
    To investigate the acute effect of sitting interruption modalities on postprandial glucose compared to prolonged sitting.
  • Change in insulin [ Time Frame: 5 hours ]
    To investigate the acute effect of sitting interruption modalities on insulin concentrations compared to prolonged sitting.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
  • Flow mediated dilation [ Time Frame: 5 hours ]
    To investigate the acute effect of sitting interruption modalities on flow mediated dilation compared to prolonged sitting
  • Blood pressure [ Time Frame: 5 hours ]
    To investigate the acute effect of sitting interruption modalities on blood pressure compared to prolonged sitting.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2018)
  • Change in flow mediated dilation [ Time Frame: 5 hours ]
    To investigate the acute effect of sitting interruption modalities on flow mediated dilation compared to prolonged sitting
  • Change in blood pressure [ Time Frame: 5 hours ]
    To investigate the acute effect of sitting interruption modalities on blood pressure compared to prolonged sitting.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sedentary Behavior Interrupted: A Trial of Acute Effects on Biomarkers of Healthy Aging
Official Title  ICMJE Sedentary Behavior Interrupted: A Randomized Crossover Trial of Acute Effects on Biomarkers of Healthy Aging in the Laboratory (Project 1)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Sedentary Lifestyle
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Behavioral: Stand More
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 17, 2018)
78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2022
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Lindsay Dillon 8585349329 ldillon@ucsd.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03511352
Other Study ID Numbers  ICMJE 171547
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Dorothy Sears, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, San Diego
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP