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Investigating Sedentary Time in Aging: New Directions

NCT ID: NCT02670369

Last Updated: 2017-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sedentary Lifestyle

Keywords

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Sedentary time Sit-to-stand transitions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Sitting time prompt

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

Group Type EXPERIMENTAL

Sitting time prompt

Intervention Type BEHAVIORAL

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

Interventions

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Sitting time prompt

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dori E Rosenberg, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Group Health Research Institute

Locations

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Group Health Research Institute

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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5K23HL119352

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5 K23 HL119352-1

Identifier Type: -

Identifier Source: org_study_id