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OpenTrials
Completed

NCT Number: NCT02670369

Investigating Sedentary Time in Aging: New Directions

The investigators are doing a study to learn how to support patients aged 60+ in taking more breaks from sitting. The goal of the study is to find out if using commercially available devices are helpful in reducing sitting time.

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Key information

Age range

60 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Group Health Research Institute

Seattle, Washington, 98101, United States

About this study

To date, no one has tested whether the prompting features of commercially available wrist-worn devices (e.g., Jawbone Up) improve breaks from sitting. Single case designs are a cost-effective way to conduct a controlled, randomized study that can inform larger intervention trials. Because the investigators are interested in ascertaining the effect of a very specific intervention on a very specific/single outcome, this study is well-suited to this approach.

The investigators will conduct iterative single case experimental studies using randomization tests. This design can help evaluate technologies for behavior change. To increase statistical power, the investigators opted to conduct an ABA study design (also termed a reversal design) where A is baseline and B is an intervention. Using randomization tests, the length of each A and B phase are determined to vary randomly in length prior to the beginning of each participant's experiment. The investigators will constrain the total time of each A and B phase to last a minimum of 5 days to provide adequate exposure to the A (measurement only) and B (intervention) conditions. The maximum total number of days participants will be enrolled is 28.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female
  • BMI of 25+
  • Ages 60+
  • Continuously enrolled at Group Health for previous 12 months
  • No record of death
  • Not on the No Contact list
  • Speaks, reads, and writes English
  • Able to hold a conversation by phone (no hearing or other limitations)
  • Self-reported ability to stand
  • Self-reported ability to walk one block unassisted
  • No history of an injury from a fall in past 3 months
  • Work or retirement situations allows for taking breaks from sitting throughout the day
  • Available for the study duration
  • No unusual activities planned (e.g. travel, moving) during the study period
  • Able to come to Group Health Capitol Hill/Central for measurement visits
  • Willing to wear activity monitor (activPAL)
  • Self-reports taking less than 4 breaks from sitting during an average hour
  • Self-reports sitting more than 7 hours per day

Exclusion criteria

  • Resides in long-term care, hospice care, or skilled nursing facility (previous 12 months)
  • Wheelchair bound
  • Diagnosis of dementia, serious mental health disorder, or substance use disorder (previous 24 months)
  • Use of an assistive device

Treatment and study plan

Sitting time prompt

Behavioral

Participants will receive a device that prompts them to take breaks from sitting approximately every 15-20 minutes.

Primary outcomes

  1. Sit-to-stand transitions

    Time frame: up to 28 days

    Number of activPAL-measured sit-to-stand transitions measured at the day level

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Acronym: ISTAND

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 1, 2016
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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