Can a Smartphone App That Includes a Chatbot-based Coaching and Incentives Increase Physical Activity in Healthy Adults?

NCT ID: NCT03384550

Last Updated: 2018-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-24
• Study Completion Date: 2018-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control

Participants in this arm receive no incentives.

As all participants, participants in this arm receive self-regulation coaching on 50% of the days during the intervention period. For each participant, days during the intervention period are randomly allocated to a coaching or a no coaching condition using an allocation ratio of 1:1.

As all participants, participants in this arm also receive either an action planning, a coping planning or no planning condition each Sunday during the intervention period. Participants are randomized to one out of nine sequences of planning interventions according to a uniform and strongly balanced intervention schedule

Group Type: ACTIVE_COMPARATOR

Self-regulation coaching

Intervention Type: BEHAVIORAL

Short (2-5 min.) dialogue with the digital coach who provides information relevant for behavioral self-regulation, such as a goal reminder, the distance between the current step count and the goal and strategies to increase daily steps. Participants are randomized to self-regulation coaching or control (no coaching) on a daily basis.

Planning

Intervention Type: BEHAVIORAL

A dialogue with the digital coach who prompts the participant to either formulate action plans (when and where the participant can go for a walk) or coping plans (strategies to respond to barriers for increasing daily steps) for the upcoming week. Participants are randomized on a weekly basis to action planning, coping planning or control (no planning).

Financial Incentives

Participants in this arm receive financial incentives.

As all participants, participants in this arm receive self-regulation coaching on 50% of the days during the intervention period. For each participant, days during the intervention period are randomly allocated to a coaching or a no coaching condition using an allocation ratio of 1:1.

As all participants, participants in this arm also receive either an action planning, a coping planning or no planning condition each Sunday during the intervention period. Participants are randomized to one out of nine sequences of planning interventions according to a uniform and strongly balanced intervention schedule

Group Type: EXPERIMENTAL

Self-regulation coaching

Intervention Type: BEHAVIORAL

Short (2-5 min.) dialogue with the digital coach who provides information relevant for behavioral self-regulation, such as a goal reminder, the distance between the current step count and the goal and strategies to increase daily steps. Participants are randomized to self-regulation coaching or control (no coaching) on a daily basis.

Planning

Intervention Type: BEHAVIORAL

A dialogue with the digital coach who prompts the participant to either formulate action plans (when and where the participant can go for a walk) or coping plans (strategies to respond to barriers for increasing daily steps) for the upcoming week. Participants are randomized on a weekly basis to action planning, coping planning or control (no planning).

Financial Incentives

Intervention Type: BEHAVIORAL

Participants receive CHF 1 ($1) for each day they meet a personalized adaptive step goal.

Charity Incentives

Participants in this receive charity incentives.

As all participants, participants in this arm receive self-regulation coaching on 50% of the days during the intervention period. For each participant, days during the intervention period are randomly allocated to a coaching or a no coaching condition using an allocation ratio of 1:1.

As all participants, participants in this arm also receive either an action planning, a coping planning or no planning condition each Sunday during the intervention period. Participants are randomized to one out of nine sequences of planning interventions according to a uniform and strongly balanced intervention schedule

Group Type: EXPERIMENTAL

Self-regulation coaching

Intervention Type: BEHAVIORAL

Short (2-5 min.) dialogue with the digital coach who provides information relevant for behavioral self-regulation, such as a goal reminder, the distance between the current step count and the goal and strategies to increase daily steps. Participants are randomized to self-regulation coaching or control (no coaching) on a daily basis.

Planning

Intervention Type: BEHAVIORAL

A dialogue with the digital coach who prompts the participant to either formulate action plans (when and where the participant can go for a walk) or coping plans (strategies to respond to barriers for increasing daily steps) for the upcoming week. Participants are randomized on a weekly basis to action planning, coping planning or control (no planning).

Charity Incentives

Intervention Type: BEHAVIORAL

Participants donate CHF 1 ($1) to a charity of choice for each day they meet a personalized adaptive step goal.

Interventions

Self-regulation coaching

Short (2-5 min.) dialogue with the digital coach who provides information relevant for behavioral self-regulation, such as a goal reminder, the distance between the current step count and the goal and strategies to increase daily steps. Participants are randomized to self-regulation coaching or control (no coaching) on a daily basis.

Intervention Type: BEHAVIORAL

Planning

A dialogue with the digital coach who prompts the participant to either formulate action plans (when and where the participant can go for a walk) or coping plans (strategies to respond to barriers for increasing daily steps) for the upcoming week. Participants are randomized on a weekly basis to action planning, coping planning or control (no planning).

Intervention Type: BEHAVIORAL

Financial Incentives

Participants receive CHF 1 ($1) for each day they meet a personalized adaptive step goal.

Intervention Type: BEHAVIORAL

Charity Incentives

Participants donate CHF 1 ($1) to a charity of choice for each day they meet a personalized adaptive step goal.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Possession of iPhone (5s or newer) or Android smartphone (Android 4.0 or higher)

Exclusion Criteria

• not enrolled in a complementary health insurance plan
• actively using an activity tracker or comparable smartphone app
• working night shifts
• presence of medical condition(s) that prohibit increased levels of physical activity

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CSS health insurance

UNKNOWN

Sponsor Role: collaborator

University of St.Gallen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tobias Kowatsch, PhD

Role: PRINCIPAL_INVESTIGATOR

University of St.Gallen

Locations

Center for Digital Health Interventions

Sankt Gallen, , Switzerland

Countries

Switzerland

References

Kramer JN, Kunzler F, Mishra V, Smith SN, Kotz D, Scholz U, Fleisch E, Kowatsch T. Which Components of a Smartphone Walking App Help Users to Reach Personalized Step Goals? Results From an Optimization Trial. Ann Behav Med. 2020 Jun 12;54(7):518-528. doi: 10.1093/abm/kaaa002.

Reference Type: DERIVED

PMID: 32182353 (View on PubMed)

Kramer JN, Kunzler F, Mishra V, Presset B, Kotz D, Smith S, Scholz U, Kowatsch T. Investigating Intervention Components and Exploring States of Receptivity for a Smartphone App to Promote Physical Activity: Protocol of a Microrandomized Trial. JMIR Res Protoc. 2019 Jan 31;8(1):e11540. doi: 10.2196/11540.

Reference Type: DERIVED

PMID: 30702430 (View on PubMed)

Other Identifiers

001-Ally

Identifier Type: -

Identifier Source: org_study_id