NCT02670369

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

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

July 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

5 months

First QC Date

July 21, 2015

Last Update Submit

October 11, 2017

Conditions

Sedentary Lifestyle

Keywords

Sedentary timeSit-to-stand transitions

Outcome Measures

Primary Outcomes (1)

  • Sit-to-stand transitions

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

    up to 28 days

Study Arms (1)

Sitting time prompt

EXPERIMENTAL

All participants will receive a prompting device (one-arm intervention).

Behavioral: Sitting time prompt

Interventions

Sitting time promptBEHAVIORAL

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

Sitting time prompt

Eligibility Criteria

Age60 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +3 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Dori E Rosenberg, PhD, MPH

    Group Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2015

First Posted

February 1, 2016

Study Start

July 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 13, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)