- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03632694
The Move for Your Health Pilot Study
August 10, 2018 updated by: Cindy Blair, PhD, MPH
Replacing Sedentary Time With Light Activity
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Health Coaching and Tech Support
Participants receive tech support for using the "Jawbone UP2" activity monitor and smartphone app, and education materials and health coaching to achieve their goals to reduce sedentary time and increase their daily steps.
|
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.
|
Active Comparator: Tech Support Only
Participants receive tech support for using the "Jawbone UP2" activity monitor and smartphone app and education materials on reducing sedentary behavior.
|
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.
|
No Intervention: Waitlist Control
Participants are instructed to maintain their regular activities.
Upon completion of the 16-week intervention, participants receive the "Jawbone UP2" activity monitor, education materials, and one session of tech support/health coaching.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline to 16-weeks
|
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
|
Baseline to 16-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline to 16-weeks
|
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
|
Baseline to 16-weeks
|
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)
|
Baseline to 16-weeks
|
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)
|
Baseline to 16-weeks
|
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)
|
Baseline to 16-weeks
|
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)
|
Baseline to 16-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cindy K Blair, PhD, MPH, University of New Mexico
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 6, 2016
Primary Completion (Actual)
July 20, 2017
Study Completion (Actual)
July 20, 2017
Study Registration Dates
First Submitted
August 8, 2018
First Submitted That Met QC Criteria
August 10, 2018
First Posted (Actual)
August 15, 2018
Study Record Updates
Last Update Posted (Actual)
August 15, 2018
Last Update Submitted That Met QC Criteria
August 10, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 16-003
- INST UNM 1520 (Other Identifier: UNM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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