Clinical trial NCT02692560: I-STAND R21: Reducing Sedentary Time in Older Adults
Official title: Take Active Breaks From Sitting (TABS): Reducing Sedentary Time in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Sedentary Lifestyle
Keywords: Sedentary time
Sit-to-stand transitions
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Hours of Sitting Time
timeFrame: 12 weeks
Secondary outcomes:
measure: Sit-to-stand Transitions
timeFrame: 12 weeks
measure: Periods of Sitting for 30+ Minutes
timeFrame: 12 weeks
measure: Physical Function
timeFrame: 12 weeks
measure: Blood Pressure (Systolic Blood Pressure)
timeFrame: 12 weeks
measure: Fasting Glucose (mg/dL)
timeFrame: 12 weeks
measure: Total Cholesterol (mg/dL)
timeFrame: 12 weeks
measure: Depressive Symptoms
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Dori E Rosenberg, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.