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

NCT02743286 | Completed DMC

• 1 other identifier: 150509
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sedentary Lifestyle

Keywords

sedentary behavior; sitting; feasibility; endothelial function; metabolism

Outcome Measures

Primary Outcomes (2)

• 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.

  Five hours

• 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.

  Five hours

Secondary Outcomes (2)

• Study feasibility

  3 months

• Change in mitochondrial metabolites

  Five hours

Study Arms (4)

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 15 2-minute standing interruptions, 3 per hour, and a mid-point bathroom break.

Behavioral: Frequent sit-to-stands

Walking breaks (Protocol C)

EXPERIMENTAL

Following 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.

Behavioral: Walking breaks

Stand More (Protocol D)

EXPERIMENTAL

Following 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.

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 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.

Also known as: Protocol B

Frequent sit-to-stands (Protocol B)

Walking breaks 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 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.

Also known as: Protocol C

Walking breaks (Protocol C)

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 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.

Also known as: Protocol D

Stand More (Protocol D)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Related Publications (1)

• 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.

  PMID: 29190761 DERIVED

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 19, 2016
• Study Start: April 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 8, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)