Physical Activities by Technology Help (PATH) (PATH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03212079|
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : August 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Prostate Cancer Lung Cancer Colorectal Cancer Cervical Cancer Oral Cancer||Behavioral: Mycoach Smart Text Behavioral: MyCoach on Amazon Alexa||Not Applicable|
If the participant agree to be in this study, the investigators will ask the participant to do the following things:
The participant will be asked questions about his/her physical activity (walking, running or other exercise) to determine if he/she are eligible to participate. If the participant is eligible and interested in participating, the investigators will ask hi/her to read and sign the consent form.
After that, the investigators will randomly assign the participant to a research group (this method would be similar to drawing numbers from a hat). The result will determine which group the participant will belong to. The study would have three different groups:
- Group one will be self-motivated to be physically active (control group)
- The second group will receive smart daily text messages only (text group);
The last group would have the Amazon Echo smart device installed in participants' homes and they will interact with a digital voice assist that will help them be active (Alexa group).
- All study participants will receive a Fitbit device which you can keep after the study.
- When the investigators start the study, the participant will be asked to start wearing wrist device immediately. For the next one week the investigators will monitor the participant daily number of steps to establish how active he/she is. The participant will not be required to change his/her daily routine in the first week.
- After the end of the first week, the investigators will ask the participant to increase his/her daily steps to at least 10 thousand steps per day for the next four weeks. In total the participant will have one week of hi/her normal daily routine and four weeks of trying to do 10 thousand steps per day or more.
- If the participant is in the control group, the investigators will ask you to try to do 10 thousand steps per day on his/her own.
- If the participant are in the text group, he/she will get smart text messages with healthy tips to help track his/her activities and reach his/her daily goal.
- If the participant is in Alexa group, a study member will visit the participant at his/her home before the end of the first week to install the Echo smart speaker and to explain to the participant how to use the voice assist to help him/her become more active for the next four weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a single center three arms randomized trial.|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Novel Individualized Intervention for Behavioral Change Among High-Risk Group Cancer Survivors : Physical Activities by Technology Help (PATH)|
|Actual Study Start Date :||April 3, 2017|
|Actual Primary Completion Date :||March 15, 2018|
|Actual Study Completion Date :||June 30, 2018|
No Intervention: Control
The participant will self motivate hi/herself to increase physical activities.
Experimental: Mycoach Smart Text
The participant will receive personalized smart text messages to encourage him/her to increase physical activities
Behavioral: Mycoach Smart Text
Personalized text messages to you cellphone to help you become more active
Other Name: Smart text
Experimental: MyCoach via Amazon Alexa
The participant will interact with intelligent coach on Amazon Alexa (a digital voice assist) to help him/her become more active
Behavioral: MyCoach on Amazon Alexa
This is an intelligent voice that you can communicate with via Amazon echo speaker
Other Name: Digital Voice Assist
- Average number of steps. Wearable sensor based [ Time Frame: 5 weeks ]The investigators will measure your physical activity by number of steps before and after intervention via wearable activity tracker.
- Total number and duration of activity bouts. Wearable sensor based [ Time Frame: 5 weeks ]Defined as 3 min. or more of uninterrupted activity measured by wearable sensor.
- Transitions between active/inactive periods. Wearable sensor based [ Time Frame: 5 weeks ]Time spent walking vs time spent sitting measured by all in one sensor.
- Daily patterns of activity. Wearable sensor based [ Time Frame: 5 weeks ]Distribution parameter of number of steps per/minute within 24 hours period. Measured by all in one sensor.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212079
|United States, Maryland|
|Johns Hopkins Bloomberg School of Public Health|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Ahmed Hassoon, MD,MPH,PMP||Johns Hopkins Bloomberg School of Public Health|