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

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Physical Activity

Clinical Trial Details

NCT number	NCT03225521
Study type	Interventional
Source	Kaiser Permanente
Contact
Status	Completed
Phase	N/A
Start date	July 18, 2015
Completion date	February 1, 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms