The Effect of an mHealth Intervention on Physical Activity and Nutrition: the FutureMe Trial

May 5, 2021 updated by: Annette Mönninghoff

The Effect of a Future-Self Avatar mHealth Intervention on Physical Activity and Nutrition: the FutureMe Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Consumer behavior is a key determinant for chronic disease risk. Mobile health (mHealth) technologies are promising in addressing the rise in risky lifestyle behaviors, as they can be leveraged in large population samples without high human resource or monetary requirements. However, research shows that mHealth technologies are less effective when used stand-alone, meaning without intervention components that require human to human interaction. Leveraging virtual reality in mHealth applications could help increase their stand-alone effectiveness.

Building on behavioral biases, and the health-action-process approach (HAPA), this trial investigates the use of a future-self avatar smartphone intervention (FutureMe app) on consumers' physical activity and food purchasing behavior. A 12-week field experiment aims to show that avatar-based health applications can support behavior change towards more active lifestyles and healthier food choices.

The FutureMe trial has the following objectives:

  1. To understand if avatar-based applications are more effective in promoting physical activity and improving food purchasing behavior compared to conventional tracking applications.
  2. To understand if providing individualized shopping tips promotes self-efficacy.
  3. To understand if providing consequential health behavior feedback increases behavior- related control over future health (outcome expectancy).
  4. To understand if avatar-based applications increase intrinsic motivation compared to conventional health-tracking applications.
  5. To understand if self-efficacy, outcome expectancy, user engagement or specific types of motivation moderate the effect on PA and foor purchasing.

The study participants recruitment process is supported by a large Swiss health insurance company. The insurer only provides access to potential study participants and is not involved in the design or execution of the study. The insurer has no access to participant study data. Participants are randomized into two groups and either receive the innovative FutureMe intervention or a control intervention consisting of a more conventional nutrition and physical activity tracking app (numeric feedback). Participants will download the respective apps to their personal mobile phone.

Step counts and food purchasing data is collected continuously throughout the trial. The respective psychological constructs (see outcome overview) are collected at baseline and after 12 weeks (end of intervention) via an online questionnaire.

The results of this study enable the evidence-based development of scalable interventions for sustainable physical activity and nutrition behavior change and advance the understanding of the psychological processes behind health behavior change.

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Saint Gallen, Switzerland, 9000
        • University of St. Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria

  • <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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FutureMe

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
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.
Active Comparator: Control

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity
Time Frame: 12 weeks
Steps will be measured daily via the GoogleFit or Apple Health application using the Smartphone's built-in accelerometer.
12 weeks
Nutri-Score
Time Frame: 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food Purchasing Behavior - Salt
Time Frame: 12 weeks
Salt in grams (g) per 100g food purchases (based on loyalty card data). Salt purchases will be measured by shopping basket, continuously over 12 weeks.
12 weeks
Food Purchasing Behavior - Proteins
Time Frame: Continuous measurement during study (12 weeks)
Proteins in grams (g) per 100g food purchases (based on loyalty card data). Protein purchases will be measured by shopping basket, continuously over 12 weeks.
Continuous measurement during study (12 weeks)
Food Purchasing Behavior - Fibers
Time Frame: Continuous measurement during study (12 weeks)
Fibers in grams (g) per 100g food purchases (based on loyalty card data). Fiber purchases will be measured by shopping basket, continuously over 12 weeks.
Continuous measurement during study (12 weeks)
Food Purchasing Behavior - Saturated Fats
Time Frame: Continuous measurement during study (12 weeks)
Saturated Fats in grams (g) per 100g food purchases (based on loyalty card data). Saturated fat purchases will be measured by shopping basket, continuously over 12 weeks.
Continuous measurement during study (12 weeks)
User Engagement 1
Time Frame: 12 weeks from beginning to end of intervention
Number of app openings during 12 week intervention period. App openings will be measured daily directly via tracking mechanisms in the app.
12 weeks from beginning to end of intervention
User Engagement 2
Time Frame: 12 weeks from beginning to end of intervention
Time spent in app measured in seconds during 12 week intervention period. Time spent in app will be measured daily directly via tracking mechanisms in the app.
12 weeks from beginning to end of intervention
Food Purchasing Behavior - Fruit & Vegetable Purchases
Time Frame: 12 weeks
Fruits and Vegetables in grams (g) per 100g food purchases (based on loyalty card data). Fruit and Vegetable purchases will be measured by shopping basket, continuously over 12 weeks.
12 weeks
Food Purchasing Behavior - Sugar (excluding Fructose & Lactose)
Time Frame: 12 weeks
Sugar in grams (g) per 100g food purchases (based on loyalty card data). Sugar purchases will be measured by shopping basket, continuously over 12 weeks.
12 weeks
Motivational Self-Efficacy
Time Frame: 12 weeks
Motivational Self-Efficacy scale adjusted from Schwarzer et al. 2007; Minimum Value: 1 (totally disagree), Maximum Value: 7 (totally agree)
12 weeks
Recovery Self-Efficacy
Time Frame: 12 weeks
Recovery Self-Efficacy scale adjusted from Schwarzer et al. 2007; Minimum Value: 1 (totally disagree), Maximum Value: 7 (totally agree)
12 weeks
Perceived behavior-related control over future health
Time Frame: 12 weeks
Perceived behavior-related control scale adjusted from Renner and Schwarzer, 2005; Minimum Value: 1 (totally disagree), Maximum Value: 7 (totally agree)
12 weeks
Autonomous Motivation
Time Frame: 12 weeks
Treatment Self-Regulation Questionnaire (TSRQ); Minimum Value: 1 (totally disagree), Maximum Value: 7 (totally agree)
12 weeks
Controlled Motivation
Time Frame: 12 weeks
Treatment Self-Regulation Questionnaire (TSRQ); Minimum Value: 1 (totally disagree), Maximum Value: 7 (totally agree)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Annette Mönninghoff, University of St. Gallen, Institute for Customer Insight

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2020

Primary Completion (Actual)

March 9, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

June 26, 2020

First Submitted That Met QC Criteria

August 6, 2020

First Posted (Actual)

August 10, 2020

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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