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

NCT03511352 | Active Not Recruiting DMC

• 1 other identifier: 171547
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 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.

Conditions

Sedentary Lifestyle

Outcome Measures

Primary Outcomes (2)

• Postprandial glucose

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

  5 hours

• Insulin

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

  5 hours

Secondary Outcomes (2)

• Flow mediated dilation

  5 hours

• Blood pressure

  5 hours

Study Arms (3)

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.

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.

Behavioral: Stand More

Interventions

Frequent sit-to-stands BEHAVIORAL

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

Frequent Sit-to-Stands (Protocol B)

Stand More BEHAVIORAL

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

Stand More (Protocol C)

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 27, 2018
• Study Start: May 8, 2018
• Primary Completion: April 30, 2024
• Study Completion: December 31, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)