A Micro-randomized Trial of HeartSteps, an mHealth Intervention for Increasing Physical Activity (HS)

HeartSteps: a Just-in-Time Adaptive Intervention for Increasing Physical Activity Amongst Sedentary Adults.

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity
• Intervention / Treatment: Behavioral: HeartSteps: A just-in-time adaptive intervention for increasing physical activity amongst sedentary adults.

Detailed Description

Physical activity is a key behavioral strategy for prevention of non-communicable diseases such as diabetes and heart disease. Mobile health (mHealth) interventions have shown promise for supporting physical activity adoption and maintenance in ways that are highly acceptable to users, scalable, and cost-efficient. This study examines two intervention strategies-contextually tailored activity suggestions and daily planning of the activity for the next day-that a mobile health intervention can use to encourage physical activity in sedentary adults.

Study participants use HeartSteps, an mHealth physical intervention developed by the research team, in their daily lives for six weeks. Over the course of the study both of the HeartSteps intervention components-contextually-tailored activity suggestions and activity planning-are micro-randomized for each participant on each of the day of the study, in order the effects on physical activity of each component separately and how those effects change over time.

The primary hypothesis for suggestions is that providing a contextually tailored activity suggestion increases participant step count over the subsequent 30 minutes following message delivery.

The first secondary hypothesis for suggestions is that the proximal effect of the contextually tailored activity suggestions on the subsequent 30-minute step count will decrease with duration in the study.

The primary hypothesis for planning is that receiving evening planning will increase step count on the following day.

The primary analyses will use the methods developed in Boruvka et al. (2017). The primary longitudinal outcome for activity suggestions will be the log of the step count in the 30 minutes subsequent to decision points. The log of the step count in the 30 minutes prior to randomization will be included as a control variable. The primary longitudinal outcome for planning will be the square root of the step count on the day following the randomization of planning treatment.

All missing but "available" minute-by-minute step counts from the wrist band will be imputed as 0. See "Allocation" section for the definition of availability. Sensitivity analyses using step counts from the mobile phone (secondary data source) will be conducted.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• English speakers,
• between 18 and 60 years of age,
• could walk for exercise without discomfort, and
• either had a full-time daytime job or a regular schedule outside the home (e.g., students)
• have a personal phone running Android 5.0 or higher or willing to use a study-provided phone as their primary phone for the duration of the study.

Exclusion Criteria:

• Need medical supervision to exercise
• Currently using an activity tracker (e.g., FitBit)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: HeartSteps intervention; For activity suggestions, at each available decision time, each participant is randomly assigned to either receive an activity suggestion or not. The randomization probability is 0.6 for receiving a message and 0.4 for not receiving a message. For activity planning, at each decision point, the participant is randomized to either receive evening planning or not at that decision time. The randomization probability for receiving planning is 0.5, and 0.5 for not receiving planning.

Behavioral: HeartSteps: A just-in-time adaptive intervention for increasing physical activity amongst sedentary adults.; HeartSteps is an Android-based mHealth intervention that contains two main intervention components: contextually-tailored suggestions for activity and planning of the next day's activity. Activity suggestions provide individuals with actionable suggestions for how they can be active in their current context. Delivered suggestions are tailored based on time of day, user's location, day of the week (weekend/weekday), and weather. HeartSteps can deliver a user activity suggestions up to five times a day. Evening planning asks users to create or choose a plan of how they will be active on the following day. Planning can be delivered once a day, in the evening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 minute step count	30-minute window after each available decision point	30 minutes
Daily step count	Daily step count on the day following treatment	24 hour day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thumbs up/down	User ratings of message usefulness (thumbs up/thumbs down rating)	30-minute window while message is available

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

General Publications

• Liao P, Klasnja P, Tewari A, Murphy SA. Sample size calculations for micro-randomized trials in mHealth. Stat Med. 2016 May 30;35(12):1944-71. doi: 10.1002/sim.6847. Epub 2015 Dec 28.
• Klasnja P, Hekler EB, Shiffman S, Boruvka A, Almirall D, Tewari A, Murphy SA. Microrandomized trials: An experimental design for developing just-in-time adaptive interventions. Health Psychol. 2015 Dec;34S(0):1220-8. doi: 10.1037/hea0000305.
• Boruvka A, Almirall D, Witkiewitz K, Murphy SA. Assessing Time-Varying Causal Effect Moderation in Mobile Health. J Am Stat Assoc. 2018;113(523):1112-1121. doi: 10.1080/01621459.2017.1305274. Epub 2017 Mar 29.
• Klasnja P, Smith S, Seewald NJ, Lee A, Hall K, Luers B, Hekler EB, Murphy SA. Efficacy of Contextually Tailored Suggestions for Physical Activity: A Micro-randomized Optimization Trial of HeartSteps. Ann Behav Med. 2019 May 3;53(6):573-582. doi: 10.1093/abm/kay067.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: July 19, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): October 25, 2018
• Last Update Submitted That Met QC Criteria: October 23, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Physical Activity; Mobile Health; Health Belief Model; Wearable Sensors; Implementation Intentions; Mobile Apps; Self Monitoring; Tailored Health Communication; Anti-Sedentary Behavior; Opportunistic Physical Activity
• Other Study ID Numbers: HUM00103127; 5R01HL125440 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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. Predrag Klasnja. 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No