- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04505124
The Effect of an mHealth Intervention on Physical Activity and Nutrition: the FutureMe Trial
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
Conditions
Intervention / Treatment
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:
- To understand if avatar-based applications are more effective in promoting physical activity and improving food purchasing behavior compared to conventional tracking applications.
- To understand if providing individualized shopping tips promotes self-efficacy.
- To understand if providing consequential health behavior feedback increases behavior- related control over future health (outcome expectancy).
- To understand if avatar-based applications increase intrinsic motivation compared to conventional health-tracking applications.
- 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Saint Gallen, Switzerland, 9000
- University of St. Gallen
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
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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.
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|
Active Comparator: Control
Participants use the a control app for 12 weeks. The control app has the following functionality:
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Activity
Time Frame: 12 weeks
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Steps will be measured daily via the GoogleFit or Apple Health application using the Smartphone's built-in accelerometer.
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12 weeks
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Nutri-Score
Time Frame: 12 weeks
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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)
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Food Purchasing Behavior - Fibers
Time Frame: Continuous measurement during study (12 weeks)
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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.
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Continuous measurement during study (12 weeks)
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Food Purchasing Behavior - Saturated Fats
Time Frame: Continuous measurement during study (12 weeks)
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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.
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Continuous measurement during study (12 weeks)
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User Engagement 1
Time Frame: 12 weeks from beginning to end of intervention
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Number of app openings during 12 week intervention period.
App openings will be measured daily directly via tracking mechanisms in the app.
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12 weeks from beginning to end of intervention
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User Engagement 2
Time Frame: 12 weeks from beginning to end of intervention
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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.
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12 weeks from beginning to end of intervention
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Food Purchasing Behavior - Fruit & Vegetable Purchases
Time Frame: 12 weeks
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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.
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12 weeks
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Food Purchasing Behavior - Sugar (excluding Fructose & Lactose)
Time Frame: 12 weeks
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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.
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12 weeks
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Motivational Self-Efficacy
Time Frame: 12 weeks
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Motivational Self-Efficacy scale adjusted from Schwarzer et al. 2007; Minimum Value: 1 (totally disagree), Maximum Value: 7 (totally agree)
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12 weeks
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Recovery Self-Efficacy
Time Frame: 12 weeks
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Recovery Self-Efficacy scale adjusted from Schwarzer et al. 2007; Minimum Value: 1 (totally disagree), Maximum Value: 7 (totally agree)
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12 weeks
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Perceived behavior-related control over future health
Time Frame: 12 weeks
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Perceived behavior-related control scale adjusted from Renner and Schwarzer, 2005; Minimum Value: 1 (totally disagree), Maximum Value: 7 (totally agree)
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12 weeks
|
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Autonomous Motivation
Time Frame: 12 weeks
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Treatment Self-Regulation Questionnaire (TSRQ); Minimum Value: 1 (totally disagree), Maximum Value: 7 (totally agree)
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12 weeks
|
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Controlled Motivation
Time Frame: 12 weeks
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Treatment Self-Regulation Questionnaire (TSRQ); Minimum Value: 1 (totally disagree), Maximum Value: 7 (totally agree)
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Annette Mönninghoff, University of St. Gallen, Institute for Customer Insight
Publications and helpful links
General 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FSA2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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