Clinical trial NCT02544867: Optimizing Sedentary Behavior Interventions to Affect Acute Physiological Changes
Official title: Optimizing Sedentary Behavior Interventions to Affect Acute Physiological
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: An emerging body of epidemiological evidence suggests that various forms of sedentary behavior, including TV viewing, occupational sitting, and total daily sitting, may be associated with all-cause and cardiovascular mortality, overweight and obesity, type 2 diabetes, depression and psychological well-being. Importantly, many of these associations were independent of participation in moderate to vigorous intensity physical activity. We propose a pilot study to assess the feasibility, acceptability and preliminary efficacy of two interventions targeting sedentary behavior. Since it is currently unknown what component of sedentary behavior exposure presents the greatest risk to health, we propose separate interventions to reduce overall sedentary time and to promote breaks in sedentary time.

Detailed description: Primary aim: To determine the acceptability and feasibility of selected personal, social and environmental strategies to reduce overall sitting time and increase the number of times participants stand up in a day.

Secondary aim: To assess whether existing and new measurement approaches can detect specific changes in sedentary behavior.

Exploratory aim: To establish whether specified intervention strategies were efficacious in reducing sedentary behavior and whether intervention effects were specific to the targeted sedentary behavior construct (e.g. decreased overall sitting time or increased number of breaks in sitting).

Eligibility criteria: Inclusion Criteria:

1. Males or females 50 -70 years of age
2. Able to attend 4 measurement visits with study staff in 3 consecutive weeks
3. Spend at least 8 hours per day sitting
4. Willing and able to wear study device for 21 days
5. Able to read and write in English
6. Able to provide written informed consent

Exclusion Criteria:

1. Do not sit for at least 8 hours per day
2. Unable to attend 4 visits
3. Diagnosis of serious chronic condition that would limit the ability to stand

Primary outcomes:
measure: Acceptability and feasibility
timeFrame: 3 weeks
Secondary outcomes:
measure: Measurement
timeFrame: 3 weeks
measure: Sedentary behavior
timeFrame: 3 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: UCSD
name: Jacqueline Kerr, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Takemoto M, Godbole S, Rosenberg DE, Nebeker C, Natarajan L, Madanat H, Nichols J, Kerr J. The search for the ejecting chair: a mixed-methods analysis of tool use in a sedentary behavior intervention. Transl Behav Med. 2020 Feb 3;10(1):186-194. doi: 10.1093/tbm/iby106.
citation: Kerr J, Takemoto M, Bolling K, Atkin A, Carlson J, Rosenberg D, Crist K, Godbole S, Lewars B, Pena C, Merchant G. Two-Arm Randomized Pilot Intervention Trial to Decrease Sitting Time and Increase Sit-To-Stand Transitions in Working and Non-Working Older Adults. PLoS One. 2016 Jan 6;11(1):e0145427. doi: 10.1371/journal.pone.0145427. eCollection 2016.