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

Physical Activity Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03225521
• Other study ID #: HUM00103127
• Secondary ID: 5R01HL125440
• Status: Completed
• Phase: N/A
• Start date: July 18, 2015
• Est. completion date: February 1, 2016

Study information

• Verified date: October 2018
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 1, 2016
• Est. primary completion date: February 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (3)

Boruvka, A., Almirall, D., Witkiewitz, K., & Murphy, S. A. (2017). Assessing Time-Varying Causal Effect Moderation in Mobile Health. Journal of the American Statistical Association, (just-accepted).

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:1220-8. doi: 10.1037/hea0000305. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 minute step count	30-minute window after each available decision point	30 minutes
Primary	Daily step count	Daily step count on the day following treatment	24 hour day
Secondary	Thumbs up/down	User ratings of message usefulness (thumbs up/thumbs down rating)	30-minute window while message is available