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Completed

NCT Number: NCT02692560

I-STAND R21: 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.

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Key information

Conditions

Obesity Behavior Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sedentary Behavior Sedentary Lifestyle Signs and Symptoms

Age range

60 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

i-STAND

Behavioral

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

Healthy Living

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 26, 2016
Registry last updated
Jun 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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