NCT04043650

Brief Summary

The aim of this research is to evaluate the efficacy of contextually tailored activity suggestions and activity planning for increasing physical activity among sedentary adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

June 10, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

2.2 years

First QC Date

July 31, 2019

Last Update Submit

October 20, 2022

Conditions

Physical Activity

Keywords

Physical ActivityMobile HealthSelf MonitoringWearable SensorsTailored Health CommunicationImplementation IntentionsMobile AppsAnti-Sedentary BehaviorOpportunistic Physical ActivityHealth Belief Model

Outcome Measures

Primary Outcomes (2)

  • 30 minute step count

    step count within the 30-minute window after each available decision point when activity suggestions are randomized. Assessed using the Fitbit Versa Activity tracker.

    30 minutes

  • Daily step count

    Daily step count on the day of treatment. Assessed using the Fitbit Versa activity tracker.

    24 hours

Secondary Outcomes (1)

  • Moderate or Vigorous Physical Activity (MVPA)

    24 hours

Study Arms (1)

HeartSteps Intervention

EXPERIMENTAL

For activity suggestions, at each available decision time, each participant is randomly assigned to either receive an activity suggestion or not.

Behavioral: HeartSteps

Interventions

HeartStepsBEHAVIORAL

HeartSteps is a smartphone based mHealth intervention that contains the following intervention components: (1) contextually-tailored suggestions for activity; (2) motivational messages aimed at keeping individuals motivated to be active; (3) planning of the next week's activity; and (4) adaptive weekly activity goals. Activity suggestions provide individuals with suggestions for how they can be active, and are tailored based on time of day, user's location, day of the week (weekend/weekday), and weather. Motivational messages are delivered to individuals via a push notification. Activity planning asks users to create a plan of how they will be active in the coming week. Participants are prompted to plan once a week. Each week, as part of the weekly planning, HeartSteps suggests an activity goal for the coming week based on their activity levels the previous week. Participants can edit the suggested goal, and the system-suggested goals top out at 150 minutes of activity per week.

Also known as: A just-in-time intervention for increasing physical activity among sedentary adults
HeartSteps Intervention

Eligibility Criteria

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

You may qualify if:

  • Individuals are able to participate in mild or moderate physical activity
  • They are competent to give informed consent
  • Individuals are regular (daily) users of a smartphone (iPhone or Android)
  • Individuals are willing to participate in the study protocols, including regularly carrying a mobile phone, using the HeartSteps application, answering phone-based questionnaires, and tracking their physical activity using the Fitbit Versa activity tracker
  • Body Mass Index (BMI, weight in kilograms (kg) divided by height in meters squared) between 25--45
  • Able to walk one mile without significant discomfort.

You may not qualify if:

  • Being mentally incapable of giving informed consent
  • Current enrollment in a formal exercise program
  • Psychiatric disorder which limits patients' ability to follow the study protocol, including psychosis or dementia
  • Orthopedic problems that prevent participation in a walking program
  • Significant peripheral neuropathy
  • Severe cognitive impairment
  • Pregnancy
  • Non-English speaking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90032, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Donna Spruijt-Metz, MFA, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: At each "decision time"-a time point when an intervention component can be delivered-each day of the study each participant is randomized between intervention or no intervention (delivery of a contextually tailored activity suggestion or no suggestion; morning motivational message or no motivational message)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 2, 2019

Study Start

June 10, 2020

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

October 24, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

A de-identified dataset (i.e., containing no raw location/GPS information) will be generated and made available to the research community. The dataset will be stripped of all codes or any other information that could be linked back to the original data or to an individual participant. Prospective users of this dataset must agree to a confidentiality agreement, meaning that they must get permission from the HeartSteps Primary Investigator to share the data with anyone else. All external requests for data will be directed to Dr. Donna Spruijt-Metz. Prospective investigators will submit a written proposal to the HeartSteps Investigator Team outlining the question they will investigate, the specific variables that they need to answer that question, their analytic plan for answering that question, and documentation of sufficient Institutional Review Board oversight (e.g., approval or exemption). Investigators will also need to sign a confidentiality agreement.

Shared Documents
STUDY PROTOCOL
Time Frame
The investigators will make de-identified versions of the data, and meta data describing these data sets, available after the main papers have been written and no later than 1 year after the close of the project. The source code for the HeartSteps system will be made available in a publicly accessible repository on github.com. At the close of the study, the de-identified data, analyzed data, and metadata could be mined by other researchers for understanding human behavior on many levels. Data from all secondary analyses datasets will be de-identified a priori where this is possible, and the de-identified data will be made available via the project website after publication of the main outcomes papers, or at one year after the close of the study, whichever comes first.
Access Criteria
The model specification files, and documentation for this project will be made available on http://github.com (or similar open-source code-sharing service) under a permissive BSD-style open-source license ( http://www.linfo.org/bsdlicense.html). Similarly, design documents, images and descriptions of new modeling techniques will be made available to the public via the project website under a Creative Commons Attribution license (http://creativecommons.org). These licenses will allow others to re-use, re-distribute, and produce derivatives of the work royalty-free and with minimal conditions. The investigators plan to release documentation along with or shortly after the publication of related research articles.

Locations

US(1)