I-STAND R21: Reducing Sedentary Time in Older Adults

• ClinicalTrials.gov Identifier: NCT02692560
• Recruitment Status: Completed
• First Posted: February 26, 2016
• Results First Posted: May 11, 2018
• Last Update Posted: June 29, 2018
• Sponsor: Kaiser Permanente
• Information provided by (Responsible Party): Kaiser Permanente

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obesity; Sedentary Lifestyle	Behavioral: I-STAND; Other: Healthy Living	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Take Active Breaks From Sitting (TABS): Reducing Sedentary Time in Older Adults
• Study Start Date: February 2016
• Actual Primary Completion Date: February 2017
• Actual Study Completion Date: February 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in Hours of Sitting Time [ Time Frame: 12 weeks ]
   Average hours of sitting time over the last 7 days measured at baseline and 12 weeks later

Secondary Outcome Measures :

1. Sit-to-stand Transitions [ Time Frame: 12 weeks ]
   Change in average daily number of activPAL-measured sit-to-stand transitions, from baseline to 12 weeks
2. Periods of Sitting for 30+ Minutes [ Time Frame: 12 weeks ]
   Change in average daily number of activPAL-measured periods of sitting for 30+ minutes without standing, from baseline to 12 weeks
3. Physical Function [ Time Frame: 12 weeks ]
   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.
4. Blood Pressure (Systolic Blood Pressure) [ Time Frame: 12 weeks ]
   Change in average of second and third blood pressure reading (for systolic blood pressure), from baseline to 12 weeks
5. Fasting Glucose (mg/dL) [ Time Frame: 12 weeks ]
   Change in fasting glucose (mg/dL) from finger stick blood draw, from baseline to 12 weeks
6. Total Cholesterol (mg/dL) [ Time Frame: 12 weeks ]
   Change in total cholesterol (mg/dL) from finger stick blood draw, from baseline to 12 weeks
7. Depressive Symptoms [ Time Frame: 12 weeks ]
   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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Washington

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, United States, 98101

Sponsors and Collaborators

Kaiser Permanente

Investigators

• Principal Investigator: Dori E Rosenberg, PhD, MPH; Kaiser Permanente

  Study Documents (Full-Text)

Documents provided by Kaiser Permanente:

Study Protocol  [PDF] February 12, 2018

Statistical Analysis Plan  [PDF] February 12, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT02692560
• Other Study ID Numbers: 1R21AG043853 ( U.S. NIH Grant/Contract )
• First Posted: February 26, 2016
• Results First Posted: May 11, 2018
• Last Update Posted: June 29, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Kaiser Permanente:

Sedentary time; Sit-to-stand transitions