Investigating Sedentary Time in Aging: New Directions

Sedentary Lifestyle Clinical Trial

— ISTAND  

Official title:

Investigating Sedentary Time in Aging: New Directions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02670369
• Other study ID #: 5 K23 HL119352-1
• Status: Completed
• Phase: N/A
• First received: July 21, 2015
• Last updated: October 11, 2017
• Start date: July 2015
• Est. completion date: December 2015

Study information

• Verified date: October 2017
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedentary Lifestyle

Intervention

Behavioral:
• Sitting time prompt
Participants will receive a device that prompts them to take breaks from sitting approximately every 15-20 minutes.

Locations

Country	Name	City	State
United States	Group Health Research Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sit-to-stand transitions	Number of activPAL-measured sit-to-stand transitions measured at the day level	up to 28 days