NCT04505124

Brief Summary

This study is a randomized controlled trial (RCT) which investigates the effect of a Future-Self Avatar intervention (FutureMe App) on physical activity (PA) and nutrition. The Health Action Process Approach (HAPA) and principles from consumer behavior theory were used to guide the development of the intervention. The study investigates the impact of avatar-based interventions on PA and food purchasing behavior and aims to understand if avatars can help increase the stand-alone effectiveness of mHealth interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Nov 2020

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

First Submitted

Initial submission to the registry

June 26, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

November 17, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

4 months

First QC Date

June 26, 2020

Last Update Submit

May 5, 2021

Conditions

Healthy

Keywords

mHealthPhysical ActivityNutritionMotivationSelf-competenceSelf-efficacyPerceived behavior related controlAvatarRandomized controlled trial

Outcome Measures

Primary Outcomes (2)

  • Physical Activity

    Steps will be measured daily via the GoogleFit or Apple Health application using the Smartphone's built-in accelerometer.

    12 weeks

  • Nutri-Score

    Nutri-Score calculated based on total food purchases; Minimum Value: -15 (A=Very Good), Maximum Value: 40 (E=Very Bad). Nutriscore will be measured by shopping basket, continuously over 12 weeks.

    12 weeks

Secondary Outcomes (13)

  • Food Purchasing Behavior - Salt

    12 weeks

  • Food Purchasing Behavior - Proteins

    Continuous measurement during study (12 weeks)

  • Food Purchasing Behavior - Fibers

    Continuous measurement during study (12 weeks)

  • Food Purchasing Behavior - Saturated Fats

    Continuous measurement during study (12 weeks)

  • User Engagement 1

    12 weeks from beginning to end of intervention

  • +8 more secondary outcomes

Study Arms (2)

FutureMe

EXPERIMENTAL

Participants use the FutureMe app for 12 weeks. The app has the following functionality: * Opportunity to personalize one's avatar * Tracking of PA (steps) and nutrition (purchasing behavior at food retailers) * Feedback on health behaviors represented through a Future-self avatar (consequential and visual feedback) * Individualized shopping tipps

Behavioral: FutureMe App

Control

ACTIVE COMPARATOR

Participants use the a control app for 12 weeks. The control app has the following functionality: * Tracking of PA (steps) and nutrition (purchasing behavior at food retailers) * Feedback on health behaviors represented through conventional dashboards (numeric \& text feedback) * Individualized shopping tipps

Behavioral: Conventional TrackingApp

Interventions

FutureMe AppBEHAVIORAL

The FutureMe app provides visual and consequential feedback through a future-self avatar, meaning that the avatar changes its body shape and some additional characteristics based on the participants' activity and food purchasing behaviors. The app tracks participants physical activity behavior (steps) by means of their smartphone (integration to GoogleFit and AppleHealth) and motivates them to increase their step counts. The app also connects to participants' grocery loyalty cards to evaluate their food shopping behavior leveraging the Nutri-score concept. The app motivates participants to improve their food purchases through concrete shopping tips provided in-app.

FutureMe
Conventional TrackingAppBEHAVIORAL

The Control Conventional Tracking app provides numeric and factual feedback through conventional data-dashboards. The app tracks participants physical activity behavior (steps) by means of their smartphone (integration to GoogleFit and AppleHealth) and motivates them to increase their step counts. The app also connects to participants' grocery loyalty cards to evaluate their food shopping behavior leveraging the Nutri-score concept. The app motivates participants to improve their food purchases through concrete shopping tips provided in-app.

Control

Eligibility Criteria

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

You may qualify if:

  • Living in Switzerland
  • German speaking
  • Participating in at least one grocery loyalty program (Migros Cumulus and/or Coop SuperCard)
  • Apple or Android smartphone
  • Healthy (self-declaration)

You may not qualify if:

  • \<18 years
  • Increasing PA or adjusting nutrition creates health risk (e.g. diabetic)
  • Not living in Switzerland
  • Not German speaking
  • Not using a grocery loyalty card

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of St. Gallen

Sankt Gallen, 9000, Switzerland

Location

Related Publications (3)

  • Steinemann N, Grize L, Ziesemer K, Kauf P, Probst-Hensch N, Brombach C. Relative validation of a food frequency questionnaire to estimate food intake in an adult population. Food Nutr Res. 2017 Mar 29;61(1):1305193. doi: 10.1080/16546628.2017.1305193. eCollection 2017.

    PMID: 28469546BACKGROUND

  • Schwarzer R, Schuz B, Ziegelmann JP, Lippke S, Luszczynska A, Scholz U. Adoption and maintenance of four health behaviors: theory-guided longitudinal studies on dental flossing, seat belt use, dietary behavior, and physical activity. Ann Behav Med. 2007 Apr;33(2):156-66. doi: 10.1007/BF02879897.

    PMID: 17447868BACKGROUND

  • Monninghoff A, Fuchs K, Wu J, Albert J, Mayer S. The Effect of a Future-Self Avatar Mobile Health Intervention (FutureMe) on Physical Activity and Food Purchases: Randomized Controlled Trial. J Med Internet Res. 2022 Jul 7;24(7):e32487. doi: 10.2196/32487.

    PMID: 35797104DERIVED

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Annette Mönninghoff

    University of St. Gallen, Institute for Customer Insight

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants are blinded. Investigators are also blinded. The intervention is delivered through a mobile phone application (care provider) and automatically and objectively assessed (through sensor and purchasing data). Some constructs are assessed via self-reported questionnaire at baseline, 12 weeks and during the 6 month voluntary follow-up (Treatment Self-Regulation Questionnaire (TSRQ); International Physical Activity Questionnaire (IPAQ short-form); Perceived competence maintaining a healthy diet (Williams, Deci \& Ryan); Perceived behavior-related control (Renner \& Schwarzer)).
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD Candidate and Project Leader

Study Record Dates

First Submitted

June 26, 2020

First Posted

August 10, 2020

Study Start

November 17, 2020

Primary Completion

March 9, 2021

Study Completion

April 30, 2021

Last Updated

May 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Based on the data privacy statement of the study and the ethic's commission application, data cannot be analyzed or shared on an individual participant basis.

Locations

CH(1)