NCT04440553

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

June 17, 2020

Last Update Submit

June 22, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Steps (measured by phone pedometer)

    Change in daily step counts (today's steps count minus yesterday's steps count)

    24 hours (measured for a period of 6 weeks)

  • Steps (measured by phone pedometer)

    Mean change in daily step counts during the course of the study

    Change from baseline to 6 week follow-up

Secondary Outcomes (3)

  • Depression scores

    Change from baseline to 6 week follow-up

  • Anxiety scores

    Change from baseline to 6 week follow-up

  • Behavioral Activation

    Change from baseline to 6 week follow-up

Study Arms (2)

Uniform random

ACTIVE COMPARATOR

In this arm the types of messages were sent out randomly, i.e. with a uniform random distribution.

Behavioral: Uniform random message delivery

Reinforcement learning

EXPERIMENTAL

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.

Behavioral: Reinforcement learning message delivery

Interventions

The uniform random intervention group receives feedback and motivational messages chosen from the messaging banks with equal probabilities.

Uniform random

The adaptive intervention group receives messages chosen from the messaging banks by a reinforcement learning algorithm.

Reinforcement learning

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caroline Figueroa

Berkeley, California, 94709, United States

Location

Related Publications (1)

  • Figueroa CA, Deliu N, Chakraborty B, Modiri A, Xu J, Aggarwal J, Jay Williams J, Lyles C, Aguilera A. Daily Motivational Text Messages to Promote Physical Activity in University Students: Results From a Microrandomized Trial. Ann Behav Med. 2022 Feb 11;56(2):212-218. doi: 10.1093/abm/kaab028.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Adrian Aguilera, PhD

    University of California, Berkeley

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were unaware of their group membership. Investigators were not blinded to group membership.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants were randomized to a uniform random group, or a reinforcement learning group. Within these groups, participants received the same types of text-messages, but the delivery schedule differed.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 19, 2020

Study Start

September 12, 2019

Primary Completion

December 10, 2019

Study Completion

December 20, 2019

Last Updated

June 24, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

Individual participant data that underlies the results reported in the articles will be made available to researchers on request after deidentification.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
After publication of the data, no end date
Access Criteria
Anyone with a methodologically sound proposal.

Locations