NCT02544867

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

6 months

First QC Date

September 4, 2015

Last Update Submit

September 4, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Acceptability and feasibility

    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

    3 weeks

Secondary Outcomes (2)

  • Measurement

    3 weeks

  • Sedentary behavior

    3 weeks

Study Arms (2)

Reduction in sitting time

EXPERIMENTAL

Those randomized to this condition focused on reducing their overall sitting time by two hours per day (a goal achieved in similar studies \[17,18\] that represented approximately a 25% reduction in daily sitting time). Participants were encouraged to reach this goal by standing in bouts of roughly 10 minutes per hour. The purpose of this arm was to investigate whether we could replicate improvements in sitting time achieved in other worksite studies in our cohort of older adults, which included both workers and non-workers.

Behavioral: Sedentary behavior

Increase in sit-to-stand transitions

EXPERIMENTAL

Those randomized to the sit-to-stand condition focused on increasing the number of sit-to-stand transitions they performed throughout the day with a goal of adding 30 additional transitions per day. Previous studies have not succeeded in increasing the number of sit-to-stand transitions in older adults, possibly because they focused on reducing overall sitting time, encouraged longer standing breaks and did not provide a specific goal for sit-to-stand transitions \[26-28\]. An increase in sit-to-stand transitions would not be expected with an increase standing intervention alone, as prolonged standing reduces the opportunity for sit-to-stand transitions.

Behavioral: Sedentary behavior

Interventions

Participants were randomized to either reduce their total sitting time or increase sit-to-stand transitions. Information was provided in person, through written materials and by emails and phone calls in both conditions. Both groups received written educational materials on the dangers of excessive sitting and reviewed a generic day to illustrate how many sitting opportunities individuals face each day. During each session, the health educator also discussed the benefits of sitting less or increasing sit-to-stand transitions (depending on study condition) and brainstormed potential barriers to implementing the new behavior as well as strategies to overcome these barriers.

Increase in sit-to-stand transitionsReduction in sitting time

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jacqueline Kerr, Phd

    UCSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 4, 2015

First Posted

September 9, 2015

Study Start

September 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

September 9, 2015

Record last verified: 2015-09

Locations