I-STAND R21: Reducing Sedentary Time in Older Adults

Take Active Breaks From Sitting (TABS): Reducing Sedentary Time in Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Sedentary Lifestyle
• Intervention / Treatment: Behavioral: I-STAND; Other: Healthy Living

Detailed Description

More than one-third of American adults over 60 have a body mass index > 30 kg/m2. These older adults have more sedentary time than any other group -- an average of 10-11 hours per day. Reducing the sedentary behavior of older adults with obesity, rather than only promoting more intensive physical activity, could provide a more feasible approach to health promotion.

This randomized control pilot trial will evaluate a 12-week intervention to decrease sitting time and increase standing time and light physical activity among sedentary older adults a body mass index > 30 kg/m2 as compared to control group. Baseline and 12-week measurements include anthropometric measures, blood draw by finger stick, cardiovascular health assessments, physical function tasks, and a survey. The intervention will consist of two in-person visits with a health coach followed by phone-based coaching.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Kaiser Permanente Washington Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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
• Willing to wear study activity monitors

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I-STAND; 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; Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time.
Active Comparator: Healthy Living; 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; Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sit-to-stand Transitions	Change in average daily number of activPAL-measured sit-to-stand transitions, from baseline to 12 weeks	12 weeks
Periods of Sitting for 30+ Minutes	Change in average daily number of activPAL-measured periods of sitting for 30+ minutes without standing, from baseline to 12 weeks	12 weeks
Physical Function	Change in Short Physical Performance Battery (SPPB) scale score, from baseline to 12 weeks. The range of scores is 0 to 12, higher values represent better physical function.	12 weeks
Blood Pressure (Systolic Blood Pressure)	Change in average of second and third blood pressure reading (for systolic blood pressure), from baseline to 12 weeks	12 weeks
Fasting Glucose (mg/dL)	Change in fasting glucose (mg/dL) from finger stick blood draw, from baseline to 12 weeks	12 weeks
Total Cholesterol (mg/dL)	Change in total cholesterol (mg/dL) from finger stick blood draw, from baseline to 12 weeks	12 weeks
Depressive Symptoms	Change in Patient Health Questionnaire (PHQ-8) scale score, from baseline to 12 weeks. The scale range is 0 to 24 with higher scores representing higher depressive symptoms. Scores of 10 or more are considered major depression.	12 weeks

Collaborators and Investigators

• Sponsor: Kaiser Permanente

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: February 24, 2016
• First Submitted That Met QC Criteria: February 25, 2016
• First Posted (Estimate): February 26, 2016

Study Record Updates

• Last Update Posted (Actual): June 29, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Sedentary time; Sit-to-stand transitions
• Other Study ID Numbers: 1R21AG043853 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO