Physical Activity Clinical Trial
Official title:
Investigating Different Intervention Components of a Smartphone App to Promote Physical Activity: The ALLY Micro-Randomized Trial
The investigators conduct a micro-randomized trial to test main effects and moderators of three different intervention components of Ally, a mHealth intervention to promote physical activity that is offered to customers of a large Swiss health insurance. Interventions include the use of different incentive strategies, a weekly planning intervention and daily message prompts to support self-regulation. The Health Action Process Approach (HAPA) as well as principles from behavioral economics were used to guide the development of interventions. Further, sensor data is collected in order to enable prediction of latent contextual variables. These data can be used to build prediction models for the user's state of receptivity, i.e. points in time where the user is able and/or willing to receive, process and utilize the support provided. The results of this study enable the evidence-based development of a just-in-time adaptive intervention for physical activity.
Just-in-time adaptive interventions (JITAIs) have recently been proposed as framework for
health interventions that exploit the potential of mobile health information and sensing
technologies. By obtaining contextual information for example from smartphone sensors (e.g.
location, time of day), a JITAI adapts the provision of interventions over time with the goal
to deliver support when the person needs it most (state of vulnerability) and is most likely
to be receptive (state of receptivity).
To facilitate the development of a JITAI for physical activity, the present study has the
following objectives:
1. To quantify main effects and interactions of three intervention components of Ally, a
mHealth intervention for physical activity.
2. To identify moderators for these intervention components to formulate evidence-based
decision rules.
3. To train machine learning models that predict the user's state of receptivity
A micro-randomized trial design is used to meet the objectives of the study. Customers of a
large Swiss health insurance company will use Ally over a 10-day baseline and a 6-week study
period. During the baseline period, participants only have access to the dashboard of the app
and no interventions are administered. During the intervention period, Ally provides daily
personalized step goals and different interventions via an interactive chatbot interface
based on the MobileCoach system (www.mobile-coach.eu). We investigate the following
intervention components as between-subject or within-subject experimental factors during the
intervention period: daily self-regulation coaching (two levels, within-subjects), a weekly
planning intervention (3 levels, within-subjects) and different incentive strategies (3
levels, between-subjects).
Primary outcome will be the difference in achievement of the daily personalized step goal
between intervention and control conditions for all intervention components. We expect all
intervention components to increase the probability of goal achievement. Sensitivity analyses
will be conducted for per protocol analysis and adjustment for covariates. Moderators of
intervention components will be investigated exploratively.
To reach objective 3, we will collect a wide range of smartphone sensor data as well as usage
logs of the Ally app throughout the study.
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