Clinical trial NCT03632694: The Move for Your Health Pilot Study
Official title: Replacing Sedentary Time With Light Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: cancer survivor
cancer survivorship
light physical activity
sedentary behavior
mHealth
Jawbone
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: University of New Mexico Cancer Center
name: American Cancer Society, Inc.
First posted: 2018-08-15
Enrollment: 54
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3-arm randomized controlled trial; participants were block randomized with equal allocation to 3 arms within 2 strata defined by body mass index (BMI; \<30 vs. \>=30 kg/m2)
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in total volume of sedentary time (hours/day)
timeFrame: Baseline to 16-weeks
measure: Change in the number of breaks in sedentary time
timeFrame: Baseline to 16-weeks
Secondary outcomes:
measure: Change in light physical activity
timeFrame: Baseline to 16-weeks
measure: Change in steps per day
timeFrame: Baseline to 16-weeks
measure: Change in physical performance
timeFrame: Baseline to 16-weeks
measure: Change in physical functioning (ranging from basic to strenuous activities)
timeFrame: Baseline to 16-weeks
measure: Change in health-related quality of life (self-reported mental, physical, and social health and well-being)
timeFrame: Baseline to 16-weeks
measure: Change in cardiometabolic markers
timeFrame: Baseline to 16-weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of New Mexico
name: Cindy K Blair, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blair CK, Harding E, Wiggins C, Kang H, Schwartz M, Tarnower A, Du R, Kinney AY. A Home-Based Mobile Health Intervention to Replace Sedentary Time With Light Physical Activity in Older Cancer Survivors: Randomized Controlled Pilot Trial. JMIR Cancer. 2021 Apr 13;7(2):e18819. doi: 10.2196/18819.