NCT03384550

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2017

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 27, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

March 27, 2018

Status Verified

December 1, 2017

Enrollment Period

2 months

First QC Date

December 14, 2017

Last Update Submit

March 24, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Daily goal achievement

    Goal achievement will be assessed daily by comparing participants daily step count to the respective individualized step goal

    seven weeks

Secondary Outcomes (4)

  • Steps per day

    seven weeks

  • Behavioral regulation in physical activity

    seven weeks

  • Engagement

    seven weeks

  • Non-usage attrition

    seven weeks

Study Arms (3)

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

Behavioral: Self-regulation coachingBehavioral: 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

Behavioral: Self-regulation coachingBehavioral: PlanningBehavioral: 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

Behavioral: Self-regulation coachingBehavioral: PlanningBehavioral: Charity Incentives

Interventions

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.

Charity IncentivesControlFinancial Incentives
PlanningBEHAVIORAL

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 IncentivesControlFinancial Incentives

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

Financial Incentives

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

Charity Incentives

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Digital Health Interventions

Sankt Gallen, 9000, Switzerland

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Tobias Kowatsch, PhD

    University of St.Gallen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2017

First Posted

December 27, 2017

Study Start

October 24, 2017

Primary Completion

December 17, 2017

Study Completion

January 31, 2018

Last Updated

March 27, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will share

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

Locations