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HealthyNCT04505124

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

A study testing FutureMe App and Conventional TrackingApp in people with Healthy, run by Annette Mönninghoff at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
FutureMe App and Conventional TrackingApp
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
1 siteSwitzerland
Study dates
17 Nov 2020to 30 Apr 2021
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

  • 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)

Who cannot join

  • <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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University of St. Gallen

    Sankt Gallen, 9000

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Conditions
Healthy
Being tested
FutureMe App, Conventional TrackingApp
Keywords
mHealth, Physical Activity, Nutrition, Motivation, Self-competence, Self-efficacy, Perceived behavior related control, Avatar, Randomized controlled trial
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FutureMe AppBehavioural

    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.

  • Conventional TrackingAppBehavioural

    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.

Study groups in NCT04505124
Study groupRoleWhat they receive
FutureMeExperimentalParticipants 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
Receives: Behavioral: FutureMe App
ControlActive comparatorParticipants 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
Receives: Behavioral: Conventional TrackingApp

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical Activity

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

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

Secondary outcomes (13)

  1. Food Purchasing Behavior - Salt

    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.

    Measured: 12 weeks

  2. Food Purchasing Behavior - Proteins

    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.

    Measured: Continuous measurement during study (12 weeks)

  3. Food Purchasing Behavior - Fibers

    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.

    Measured: Continuous measurement during study (12 weeks)

  4. Food Purchasing Behavior - Saturated Fats

    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.

    Measured: Continuous measurement during study (12 weeks)

  5. User Engagement 1

    Number of app openings during 12 week intervention period. App openings will be measured daily directly via tracking mechanisms in the app.

    Measured: 12 weeks from beginning to end of intervention

  6. User Engagement 2

    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.

    Measured: 12 weeks from beginning to end of intervention

  7. Food Purchasing Behavior - Fruit & Vegetable Purchases

    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.

    Measured: 12 weeks

  8. Food Purchasing Behavior - Sugar (excluding Fructose & Lactose)

    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.

    Measured: 12 weeks

  9. Motivational Self-Efficacy

    Motivational Self-Efficacy scale adjusted from Schwarzer et al. 2007; Minimum Value: 1 (totally disagree), Maximum Value: 7 (totally agree)

    Measured: 12 weeks

  10. Recovery Self-Efficacy

    Recovery Self-Efficacy scale adjusted from Schwarzer et al. 2007; Minimum Value: 1 (totally disagree), Maximum Value: 7 (totally agree)

    Measured: 12 weeks

  11. Perceived behavior-related control over future health

    Perceived behavior-related control scale adjusted from Renner and Schwarzer, 2005; Minimum Value: 1 (totally disagree), Maximum Value: 7 (totally agree)

    Measured: 12 weeks

  12. Autonomous Motivation

    Treatment Self-Regulation Questionnaire (TSRQ); Minimum Value: 1 (totally disagree), Maximum Value: 7 (totally agree)

    Measured: 12 weeks

  13. Controlled Motivation

    Treatment Self-Regulation Questionnaire (TSRQ); Minimum Value: 1 (totally disagree), Maximum Value: 7 (totally agree)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2020
  2. Study start17 Nov 2020
  3. Primary completion9 Mar 2021
  4. Study completion30 Apr 2021

Resources

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04505124
Sponsor's protocol ID
FSA2020
Status last verified
May 2021
First submitted
26 Jun 2020
Last updated
6 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 28469546

  • 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.

    PubMed 17447868

  • 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.

    PubMed 35797104

Questions about this trial

What is this clinical trial studying?

A study testing FutureMe App and Conventional TrackingApp in people with Healthy, run by Annette Mönninghoff 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 5 inclusion and 5 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 6 May 2021. 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?

Physical Activity (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT04505124, which also lists 3 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 6 May 2021.

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