I-STAND R21: Reducing Sedentary Time in Older Adults

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02692560

Enrollment

Registered

2016-02-26

Start date

2016-02-29

Completion date

2017-02-28

Last updated

2018-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Sedentary Lifestyle

Keywords

Sedentary time, Sit-to-stand transitions

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.

Interventions

BEHAVIORALI-STAND

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

OTHERHealthy Living

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to 89 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Hours of Sitting Time	12 weeks	Average hours of sitting time over the last 7 days measured at baseline and 12 weeks later

Secondary

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

Countries

United States

Participant flow

Participants by arm

Arm	Count
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. I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time.	29
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. Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees.	31
Total	60

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	0	6

Baseline characteristics

Characteristic	I-STAND	Healthy Living	Total
Age, Continuous	69.0 years STANDARD_DEVIATION 4.7	67.8 years STANDARD_DEVIATION 5.2	68.4 years STANDARD_DEVIATION 4.9
Body mass index	36.6 kg/m^2 STANDARD_DEVIATION 6.1	36.0 kg/m^2 STANDARD_DEVIATION 3.8	36.3 kg/m^2 STANDARD_DEVIATION 5
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	1 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants	29 Participants	57 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	2 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	1 Participants	4 Participants	5 Participants
Race (NIH/OMB) More than one race	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) White	28 Participants	23 Participants	51 Participants
Region of Enrollment United States	29 Participants	31 Participants	60 Participants
Sex: Female, Male Female	20 Participants	21 Participants	41 Participants
Sex: Female, Male Male	9 Participants	10 Participants	19 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 29	0 / 31
other Total, other adverse events	4 / 29	0 / 31
serious Total, serious adverse events	0 / 29	0 / 31

Outcome results

Primary