I-STAND R21: Reducing Sedentary Time in Older Adults

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692560
• Other study ID #: 1R21AG043853
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: February 2017

Study information

• Verified date: May 2018
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Sedentary Lifestyle

Intervention

Behavioral:
• I-STAND
Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time.

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

Locations

Country	Name	City	State
United States	Kaiser Permanente Washington Health Research Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sit-to-stand Transitions	Change in average daily number of activPAL-measured sit-to-stand transitions, from baseline to 12 weeks	12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Fasting Glucose (mg/dL)	Change in fasting glucose (mg/dL) from finger stick blood draw, from baseline to 12 weeks	12 weeks
Secondary	Total Cholesterol (mg/dL)	Change in total cholesterol (mg/dL) from finger stick blood draw, from baseline to 12 weeks	12 weeks
Secondary	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