- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04440553
A Mobile App to Increase Physical Activity in Students
An mHealth App Using Adaptive Learning to Increase Physical Activity in University Students
Background: Insufficient physical activity is one of the leading risk factors of death worldwide. Behavioral treatments delivered via smartphone apps, hold great promise for helping people engage in healthy behaviors including becoming more physically active. However, similar to 'face-to-face' treatments, effects typically do not seem to be sustained over longer periods of time.
Methods: the investigators developed a smartphone application that uses different types of motivational and feedback text-messaging to motivate individuals to increase physical activity. Here, participants are randomized to either receive messages by a uniform random distribution (n=50), or chosen by a reinforcement learning algorithm (n=50), which learns from daily participant data to personalize the frequency and type of motivation of messages.
Objectives: In the current study, the investigators examine this application in undergraduate and graduate students at the University of California, Berkeley. The investigators compare whether participants in the uniform random or adaptive group have higher increases in steps during the study. The investigators also examine the effect of the different types of messages on step counts. Further the investigators assess the influence of patient characteristics, such as socio-demographic, psychological questionnaire scores and baseline physical activity on the effect of the adaptive arm and effectiveness of the messages. Finally, the investigators assess participant qualitative feedback on the text-messaging program, through feedback provided via questionnaires, text-message and phone interviews.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators developed a smartphone application, the DIAMANTE app, that uses machine learning to generate adaptive text messages, learning from daily participant data to personalize the frequency and type of motivation of messages. In the current study, the investigators will compare this application in undergraduate and graduate students at the University of Berkeley, to text-messaging chosen randomly. This study will provide insight into the effectiveness of this smartphone application for increasing physical activity in university students. Further, it will provide preliminary knowledge on the working mechanisms and variables that moderate the effectiveness of the intervention.
This study is characterized by a factorial design with a total of 3 factors representing Motivational Messages (M), Feedback Messages (F) and the Time Frame (T) when the message was sent, of 4, 5 and 4 levels each, respectively. One level of M and F corresponded to a control treatment, i.e., no message sent. Each participant received one different combination of M, F and T every day.
Both the adaptive and uniform random group will receive the same types of messages: feedback (4 active categories plus no message) and motivation (3 active categories plus no message). However, the message categories, timing and frequency will be optimized by a reinforcement learning algorithm in the adaptive group, and will be delivered with equal probabilities in the uniform random group (following a uniform random distribution).
For the reinforcement learner group, the algorithm training data consists of the historical data of all participants (contextual variables), which include which messages were sent previously and within which time periods, and select clinical/demographic data (such as age, day of the week and depression scores) to improve prediction abilities. Subsequently, the message is chosen based on the predicted effectiveness of messages, combined with a sampling method. As such, it frequently picks out from the most rewarding messages and occasionally explores the messages with uncertainty in their reward.
The aims of this study are:
- to assess if participants in the reinforcement learning policy show a greater increase in daily steps after six week follow-up, than participants receiving messages with a uniform random distribution
- to assess if sociodemographic, baseline physical activity behavior/attitudes and psychological factors influence the effect of the adaptive intervention.
- to assess which messages are most beneficial in increasing physical activity.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Berkeley, California, United States, 94709
- Caroline Figueroa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: We will include currently enrolled undergraduate and graduate students ages 18 to 65.
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Exclusion Criteria: Students that do not have a smartphone, are not able to exercise due to disability, or have plans to leave the country during the 6 week study will be excluded.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Uniform random
In this arm the types of messages were sent out randomly, i.e. with a uniform random distribution.
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The uniform random intervention group receives feedback and motivational messages chosen from the messaging banks with equal probabilities.
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Experimental: Reinforcement learning
In this arm the types of messages were chosen by a reinforcement learning algorithm.
The decision about which message to send was based on several contextual variables, including data for the pedometer app, and consecutive days since messages from different categories were sent.
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The adaptive intervention group receives messages chosen from the messaging banks by a reinforcement learning algorithm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Steps (measured by phone pedometer)
Time Frame: 24 hours (measured for a period of 6 weeks)
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Change in daily step counts (today's steps count minus yesterday's steps count)
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24 hours (measured for a period of 6 weeks)
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Steps (measured by phone pedometer)
Time Frame: Change from baseline to 6 week follow-up
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Mean change in daily step counts during the course of the study
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Change from baseline to 6 week follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression scores
Time Frame: Change from baseline to 6 week follow-up
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Patient Health Questionnaire 9 item (PHQ-9).
The PHQ-9 has scores from 0 to 27.
Higher scores mean a worse outcome.
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Change from baseline to 6 week follow-up
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Anxiety scores
Time Frame: Change from baseline to 6 week follow-up
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General Anxiety Disorder 7 item (GAD-7).
The GAD-7 has scores from 0 to 21.
Higher scores mean a worse outcome.
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Change from baseline to 6 week follow-up
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Behavioral Activation
Time Frame: Change from baseline to 6 week follow-up
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Behavioral Activation for Depression Scale - Short Form (BADS-SF).
The BADS-SF has scores from 0-54.
Higher scores mean better outcomes.
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Change from baseline to 6 week follow-up
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Collaborators and Investigators
Investigators
- Principal Investigator: Adrian Aguilera, PhD, University of California, Berkeley
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019-04-12118
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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