The Move for Your Health Pilot Study

Cancer Clinical Trial

Official title:

Replacing Sedentary Time With Light Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03632694
• Other study ID #: 16-003
• Secondary ID: INST UNM 1520
• Status: Completed
• Phase: N/A
• Start date: July 6, 2016
• Est. completion date: July 20, 2017

Study information

• Verified date: August 2018
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 20, 2017
• Est. primary completion date: July 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Health Coaching and Tech Support
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Cindy Blair, PhD, MPH	American Cancer Society, Inc., University of New Mexico Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total volume of sedentary time (hours/day)	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	Baseline to 16-weeks
Primary	Change in the number of breaks in sedentary time	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	Baseline to 16-weeks
Secondary	Change in light physical activity	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	Baseline to 16-weeks
Secondary	Change in steps per day	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	Baseline to 16-weeks
Secondary	Change in physical performance	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)	Baseline to 16-weeks
Secondary	Change in physical functioning (ranging from basic to strenuous activities)	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)	Baseline to 16-weeks
Secondary	Change in health-related quality of life (self-reported mental, physical, and social health and well-being)	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)	Baseline to 16-weeks
Secondary	Change in cardiometabolic markers	Change in fasting glucose, insulin and lipids, as well as high-sensitivity C-Reactive Protein (CRP)	Baseline to 16-weeks