Physical ActivityNCT03384550
Can a Smartphone App That Includes a Chatbot-based Coaching and Incentives Increase Physical Activity in Healthy Adults?
A study testing Self-regulation coaching, Planning and Financial Incentives in people with Physical Activity, run by University of St.Gallen at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Self-regulation coaching, Planning and Financial Incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Oct 2017to 31 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Possession of iPhone (5s or newer) or Android smartphone (Android 4.0 or higher)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Center for Digital Health Interventions
Sankt Gallen, 9000
About this study
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.
Read the 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:
- To quantify main effects and interactions of three intervention components of Ally, a mHealth intervention for physical activity.
- To identify moderators for these intervention components to formulate evidence-based decision rules.
- 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
- Being tested
- Self-regulation coaching, Planning, Financial Incentives, Charity Incentives
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-regulation coachingBehavioural
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.
PlanningBehavioural
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 IncentivesBehavioural
Participants receive CHF 1 ($1) for each day they meet a personalized adaptive step goal.
Charity IncentivesBehavioural
Participants donate CHF 1 ($1) to a charity of choice for each day they meet a personalized adaptive step goal.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 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 Receives: Behavioral: Self-regulation coaching; Behavioral: Planning |
| Financial Incentives | Experimental | 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 Receives: Behavioral: Self-regulation coaching; Behavioral: Planning; Behavioral: Financial Incentives |
| Charity Incentives | Experimental | 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 Receives: Behavioral: Self-regulation coaching; Behavioral: Planning; Behavioral: Charity Incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily goal achievement
Goal achievement will be assessed daily by comparing participants daily step count to the respective individualized step goal
Measured: seven weeks
Secondary outcomes (4)
Steps per day
Steps will be measured daily via the GoogleFit or Apple Health application using the smartphone's built-in accelerometer
Measured: seven weeks
Behavioral regulation in physical activity
Behavioral regulation in physical activity will be measured using the second version of the Behavioral Regulation in Exercise Questionnaire (BREQ-2). The BREQ-2 consists of five subscales which represent different forms of regulation along the extrinisc-intrinsic continuum of motivation. Because the external regulation subscale in the BREQ-2 exclusively relates to external regulation by other people, it is substituted by the corresponding sub-scale of the Situational Motivation Scale (SIMS). Scores will be reported for each subscale separately. Answers are given on a five-point likert scale with the endpoints 0-not true for me and 4-very true for me.
Scores range from 0 to 16 for the subscales amotivation, external regulation, identified regulation and intrinsic regulation and from 0-12 for the subscale introjected regulation with higher scores representing a stronger manifestation of the respective form of regulation.
Measured: seven weeks
Engagement
App engagement is measured using the number and length of app launch sessions per day. An app launch session is defined as any interaction of the user with the Ally app, separated by five minutes between events. If a user left the app open and did not take action for 5 minutes or more, then the next interaction with the app counts as a new session.
Measured: seven weeks
Non-usage attrition
Non-usage attrition is measured using the proportion of users that have stopped using the app for at least 7 days (i.e. there are >7 days between their last session and the end of the study,
Measured: seven weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start24 Oct 2017
- Primary completion17 Dec 2017
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of St.Gallen
- Sponsor type
- University, hospital or other
- Collaborators
- CSS health insurance
- Responsible party
- Sponsor
- Investigators
- Tobias Kowatsch, PhD, Principal investigator, University of St.Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384550
- Sponsor's protocol ID
- 001-Ally
- Status last verified
- Dec 2017
- First submitted
- 14 Dec 2017
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data will be irreversibly anonymized and made available in a public non-profit data repository. Data that can potentially identify participants will be deleted (e.g. e-mail addresses) or altered in a way that prevents identification (e.g. global positioning system (GPS) data will be converted to abstract features, such as "at home/not at home"). Consent to publish anonymized data is obtained from all participants.
Publications
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.
PubMed 32182353Kramer 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.
PubMed 30702430
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Different Intervention Components of a Smartphone App to Promote Physical Activity: The ALLY Micro-Randomized Trial
- ClinicalTrials.gov ID
- NCT03384550
- Acronym / sponsor ID
- 001-Ally
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- University of St.GallenUniversity, hospital or other
- Collaborators
- CSS health insurance
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 17 Dec 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To quantify main effects and interactions of three intervention components of Ally, a mHealth intervention for physical activity.
- To identify moderators for these intervention components to formulate evidence-based decision rules.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Self-regulation coaching, Behavioral: PlanningParticipants 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 |
| Financial Incentives | Experimental | Behavioral: Self-regulation coaching, Behavioral: Planning, Behavioral: Financial IncentivesParticipants 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 |
| Charity Incentives | Experimental | Behavioral: Self-regulation coaching, Behavioral: Planning, Behavioral: Charity IncentivesParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Possession of iPhone (5s or newer) or Android smartphone (Android 4.0 or higher)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-regulation coachingShort (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. | Behavioural | Charity Incentives, Control, Financial Incentives |
| PlanningA 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). | Behavioural | Charity Incentives, Control, Financial Incentives |
| Financial IncentivesParticipants receive CHF 1 ($1) for each day they meet a personalized adaptive step goal. | Behavioural | Financial Incentives |
| Charity IncentivesParticipants donate CHF 1 ($1) to a charity of choice for each day they meet a personalized adaptive step goal. | Behavioural | Charity Incentives |
Primary outcome
Daily goal achievement
Time frame: seven weeks
Goal achievement will be assessed daily by comparing participants daily step count to the respective individualized step goal
4 secondary outcomes
Steps per day
Time frame: seven weeks
Behavioral regulation in physical activity
Time frame: seven weeks
Engagement
Time frame: seven weeks
Non-usage attrition
Time frame: seven weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Derived from this study: PubMed 32182353Kramer 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.
- Derived from this study: PubMed 30702430Kramer 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.
- Individual participant dataSharing planned: Yes. All collected data will be irreversibly anonymized and made available in a public non-profit data repository. Data that can potentially identify participants will be deleted (e.g. e-mail addresses) or altered in a way that prevents identification (e.g. global positioning system (GPS) data will be converted to abstract features, such as "at home/not at home"). Consent to publish anonymized data is obtained from all participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Kowatsch, PhD principal investigator
University of St.Gallen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-regulation coaching, Planning and Financial Incentives in people with Physical Activity, run by University of St.Gallen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily goal achievement (time frame: seven weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03384550, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018; AzTrials last refreshed its copy on 27 Oct 2026.