An interventional study of Self-regulation coaching and Planning in Physical Activity, sponsored by University of St.Gallen. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-27.
Sponsored by University of St.Gallen · Not applicable, Interventional, and Prevention
Among 143 studies in Motor Activity with a site in Switzerland — 24 open to participants now, 25 under way, none of them phase 3. Motor Activity · Switzerland.
Among the 143 studies in Motor Activity with a site in Switzerland, this one is the 11th largest by enrollment of the 110 interventional ones that give a count, is one of 7 that started in 2017, is one of 102 with no phase, and was the 54th registered.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
Browse Motor Activity studies →24 of the 143 studies in Motor Activity with a site in Switzerland are open now. Recruiting first, the newest first:
University of Lausanne · Sites in Switzerland
Mona Lichtblau · Sites in Switzerland
University Hospital, Basel, Switzerland · Sites in Switzerland
Bern University of Applied Sciences · Sites in Switzerland
St.Gallen University of Applied Sciences · Sites in Switzerland
A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →
Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
143 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 4 · Phase 3 1 · Phase 4 2
First in 2000; this study’s year is marked. 7 started in 2017.
This study's enrollment of 274 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Median enrollment 60 across the 110 interventional studies, 120 across the 33 observational. Of the 105 that completed or were terminated, 2 (2%) have results posted.
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4 of 143 have an industry lead sponsor. The 10 most frequent:
University of St.Gallen is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
University of St.Gallen has 1 study filed under Motor Activity — fewer than ten, so there is no comparison to draw.
4 of the studies in Motor Activity with a site in Switzerland that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07305389Elena TessitoreThe MUSICare Project: Effects of Differentiated Music Exposure on Exercise-Related Affect Among Cardiac Rehabilitation Inpatients | 2027-01-30 |
| NCT07430943Mona LichtblauFeasibility of Integrating Street Racket Into Ambulatory Pulmonary Rehabilitation | 2027-02-28 |
| NCT07815366University of ZurichEffectiveness of Eccentric Cycling Exercise in Ambulatory Rehabilitation for Patients With Cardiopulmonary Diseases: A Pragmatic Randomized Controlled Trial | 2027-05-01 |
| NCT07074639Eleftheria GiannouliCognitive-Motor Exergame Training in Frail Adults | 2027-05-31 |
Among the 143 studies in Motor Activity with a site in Switzerland, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Behavioral: Self-regulation coaching · Behavioral: Planning
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
Behavioral: Self-regulation coaching · Behavioral: Planning · Behavioral: Financial 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
Behavioral: Self-regulation coaching · Behavioral: Planning · Behavioral: Charity Incentives
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.
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).
Participants receive CHF 1 ($1) for each day they meet a personalized adaptive step goal.
Participants donate CHF 1 ($1) to a charity of choice for each day they meet a personalized adaptive step goal.
Daily goal achievement
Goal achievement will be assessed daily by comparing participants daily step count to the respective individualized step goal
Time frame: seven weeks
Steps per day
Steps will be measured daily via the GoogleFit or Apple Health application using the smartphone's built-in accelerometer
Time frame: 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.
Time frame: 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.
Time frame: 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,
Time frame: seven weeks
Plan to share: 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.
Time frame: After completion of all analyses and publication of the main results of the study
Ran from Oct 2017 to primary completion in Dec 2017, 1 month.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 1 month is below that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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University of St.Gallen