The Move for Your Health Pilot Study

NCT ID: NCT03632694

Last Updated: 2018-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-06

Study Completion Date

2017-07-20

Brief Summary

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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

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Health Coaching and Tech Support

Intervention Type 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

Participants receive tech support for using the "Jawbone UP2" activity monitor and smartphone app and education materials on reducing sedentary behavior.

Group Type ACTIVE_COMPARATOR

Tech Support Only

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of New Mexico Cancer Center

OTHER

Sponsor Role collaborator

American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Cindy Blair, PhD, MPH

OTHER

Sponsor Role lead

Responsible Party

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Cindy Blair, PhD, MPH

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Cindy K Blair, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

References

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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.

Reference Type DERIVED
PMID: 33847588 (View on PubMed)

Other Identifiers

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INST UNM 1520

Identifier Type: OTHER

Identifier Source: secondary_id

16-003

Identifier Type: -

Identifier Source: org_study_id

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