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Completed

NCT Number: NCT03632694

The Move for Your Health Pilot Study

The Move for Your Health Pilot Study is a 16-week study in older cancer survivors to replace and break-up sedentary activity with short bouts of light physical activity.

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Key information

Conditions

Cancer Behavior Neoplasms Sedentary Behavior

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This pilot study will determine the feasibility and acceptability of a mobile health (mHealth) intervention to replace and break-up sedentary time with intermittent bouts of light physical activity. The intervention uses an electronic activity monitor ("Jawbone UP2"; worn on the wrist) that pairs with a mobile app, which together promote awareness and enable self-monitoring of both physical activity (steps per day) and inactivity (wristband gently vibrates after a specified time of inactivity). Pre-post intervention change in objective, subjective, and biologic data will be compared between groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 60 years or older at the time of enrollment
  • Diagnosed with local or regionally staged cancer (any site) and completed primary treatment
  • Own a smartphone capable of running the "Jawbone UP2" app
  • Willingness to be randomized to any of the 3 study arms, attend 2 clinic visits, and wear activity monitors (activPAL and actiGraph) at weeks 1 and 16 for 7 days; "Jawbone UP2" wristband monitor during weeks 2-16 during waking hours.
  • Able to read, speak, and understand English.
  • Living independently and capable of walking 3 blocks (approximately 1300 steps or 0.25 mile) without an assistive device (e.g., cane, walker)
  • Residence within Bernalillo County or the four surrounding counties (to reduce travel burden)

Exclusion criteria

  • Currently participating in a program to decrease sedentary time or increase physical activity
  • Paid employment or volunteer position for greater than 20 hours per week
  • Severe impairments or pre-existing medical limitations for engaging in daily light physical activity
  • Wrist size >20 cm

Treatment and study plan

Health Coaching and Tech Support

Behavioral

Participants will receive a "Jawbone UP2" activity monitor and education materials about the negative consequences of sedentary behavior and suggestions for breaking up sedentary time with light physical activity. Participants receive 5 telephone coaching calls to set up the "Jawbone UP2" monitor with their smartphone app and receive tech support help with changing the settings/goals on the app. Additionally, this arm receives health coaching to provide encouragement and further motivate and help study participants to modify their sedentary behavior.

Tech Support Only

Behavioral

Participants will receive a "Jawbone UP2" activity monitor and education materials about the negative consequences of sedentary behavior and suggestions for breaking up sedentary time with light physical activity. Participants receive 5 telephone coaching calls to set up the "Jawbone UP2" monitor with their smartphone app and receive tech support help with changing the settings/goals on the app. However, there is no additional health coaching.

Primary outcomes

  1. Change in total volume of sedentary time (hours/day)

    Time frame: Baseline to 16-weeks

    Change in the average number of hours/day of sedentary time measured over a 1-week period using activPAL, at both baseline and 16-weeks post-intervention

  2. Change in the number of breaks in sedentary time

    Time frame: Baseline to 16-weeks

    Change in the average number of breaks in sedentary time measured over a 1-week period using activPAL, at both baseline and 16-weeks post-intervention

Secondary outcomes

  1. Change in light physical activity

    Time frame: Baseline to 16-weeks

    Change in the average number of hours per day spent in light physical activity (or higher intensity) measured over a 1-week period using activPAL, at both baseline and 16-weeks post-intervention

  2. Change in steps per day

    Time frame: Baseline to 16-weeks

    Change in the average number of steps per day measured over a 1-week period using activPAL, at both baseline and 16-weeks post-intervention

  3. Change in physical performance

    Time frame: Baseline to 16-weeks

    Change in the average physical performance score as measured by the Short Physical Performance Battery (SPPB). This performance battery includes chair stands, balance tests, and the 8-foot usual gait speed. Each subscale score ranges from 0 (cannot do) to 4 (good performance). The subscales are summed for a total score, which ranges from 0 (lowest level of performance) to 12 (highest level of performance)

  4. Change in physical functioning (ranging from basic to strenuous activities)

    Time frame: Baseline to 16-weeks

    Change in self-reported physical functioning as measured by the 36-item Short Form Survey (SF-36) physical functioning subscale. Raw scores range from 0 (worst functioning) to 100 (best functioning)

  5. Change in health-related quality of life (self-reported mental, physical, and social health and well-being)

    Time frame: Baseline to 16-weeks

    Change in quality of life as measured by the SF-36; each of the 8 subscales and 2 component summary scores; scores based on proprietary algorithm from Optum; higher scores represent better quality of life)

  6. Change in cardiometabolic markers

    Time frame: Baseline to 16-weeks

    Change in fasting glucose, insulin and lipids, as well as high-sensitivity C-Reactive Protein (CRP)

Sponsors and collaborators

Lead sponsor

Cindy Blair, PhD, MPH

Other

Collaborators

  • American Cancer Society, Inc.
  • University of New Mexico Cancer Center

Registry information

Official study title

Replacing Sedentary Time With Light Activity

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 15, 2018
Registry last updated
Aug 15, 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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