NCT02692560

Brief Summary

The investigators are doing a study to learn how to support patients aged 60+ in taking more breaks from sitting and reducing total sitting time. The goal of the study is to find out if a sitting time reduction intervention reduces sitting time compared with a control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable obesity

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

February 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 11, 2018

Completed
Last Updated

June 29, 2018

Status Verified

May 1, 2018

Enrollment Period

1 year

First QC Date

February 24, 2016

Results QC Date

February 22, 2018

Last Update Submit

May 30, 2018

Conditions

Keywords

Sedentary timeSit-to-stand transitions

Outcome Measures

Primary Outcomes (1)

  • Change in Hours of Sitting Time

    Average hours of sitting time over the last 7 days measured at baseline and 12 weeks later

    12 weeks

Secondary Outcomes (7)

  • Sit-to-stand Transitions

    12 weeks

  • Periods of Sitting for 30+ Minutes

    12 weeks

  • Physical Function

    12 weeks

  • Blood Pressure (Systolic Blood Pressure)

    12 weeks

  • Fasting Glucose (mg/dL)

    12 weeks

  • +2 more secondary outcomes

Study Arms (2)

I-STAND

EXPERIMENTAL

Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.

Behavioral: I-STAND

Healthy Living

ACTIVE COMPARATOR

Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.

Other: Healthy Living

Interventions

I-STANDBEHAVIORAL

Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time.

I-STAND

Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees.

Healthy Living

Eligibility Criteria

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

You may qualify if:

  • Kaiser Permanente Washington enrollees
  • Men and women
  • Age 60 - 89
  • BMI 30 - 50 (calculated based on most recent height ever and most recent weight taken within previous 18 months)
  • Primary care within Integrated Group Practice
  • Continuously enrolled at Kaiser Permanente Washington for previous 12 months
  • No record of death
  • Not on the No Contact list
  • Speaks and writes English
  • Able to hold a conversation by phone (no hearing or other limitations)
  • Self-reported sitting time of 6 hours/day or more
  • Self-reported ability to stand with or without an assistive device
  • Self-reported ability to walk one block with or without an assistive device
  • Available for the study duration
  • Able to come to Kaiser Permanente Washington Health Research Institute's research clinic for measurement visits
  • +1 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)

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (2)

  • Matson TE, Renz AD, Takemoto ML, McClure JB, Rosenberg DE. Acceptability of a sitting reduction intervention for older adults with obesity. BMC Public Health. 2018 Jun 7;18(1):706. doi: 10.1186/s12889-018-5616-1.

  • Rosenberg DE, Lee AK, Anderson M, Renz A, Matson TE, Kerr J, Arterburn D, McClure JB. Reducing Sedentary Time for Obese Older Adults: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Feb 12;7(2):e23. doi: 10.2196/resprot.8883.

MeSH Terms

Conditions

ObesitySedentary Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Results Point of Contact

Title
Dori Rosenberg, PhD, MPH
Organization
Kaiser Permanente Washington Health Research Institute

Study Officials

  • Dori E Rosenberg, PhD, MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2016

First Posted

February 26, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

June 29, 2018

Results First Posted

May 11, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations