Clinical trial NCT04505124: The Effect of an mHealth Intervention on Physical Activity and Nutrition: the FutureMe Trial
Official title: The Effect of a Future-Self Avatar mHealth Intervention on Physical Activity and Nutrition: the FutureMe Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: mHealth
Physical Activity
Nutrition
Motivation
Self-competence
Self-efficacy
Perceived behavior related control
Avatar
Randomized controlled trial
Lead sponsor: University of St.Gallen
Sponsor class: OTHER
Collaborators: name: Helsana Zusatzversicherungen AG
name: ETH Zurich
First posted: 2020-08-10
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical Activity
timeFrame: 12 weeks
measure: Nutri-Score
timeFrame: 12 weeks
Secondary outcomes:
measure: Food Purchasing Behavior - Salt
timeFrame: 12 weeks
measure: Food Purchasing Behavior - Proteins
timeFrame: Continuous measurement during study (12 weeks)
measure: Food Purchasing Behavior - Fibers
timeFrame: Continuous measurement during study (12 weeks)
measure: Food Purchasing Behavior - Saturated Fats
timeFrame: Continuous measurement during study (12 weeks)
measure: User Engagement 1
timeFrame: 12 weeks from beginning to end of intervention
measure: User Engagement 2
timeFrame: 12 weeks from beginning to end of intervention
measure: Food Purchasing Behavior - Fruit & Vegetable Purchases
timeFrame: 12 weeks
measure: Food Purchasing Behavior - Sugar (excluding Fructose & Lactose)
timeFrame: 12 weeks
measure: Motivational Self-Efficacy
timeFrame: 12 weeks
measure: Recovery Self-Efficacy
timeFrame: 12 weeks
measure: Perceived behavior-related control over future health
timeFrame: 12 weeks
measure: Autonomous Motivation
timeFrame: 12 weeks
measure: Controlled Motivation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Saint Gallen
country: Switzerland
facility: University of St. Gallen
Study officials:
affiliation: University of St. Gallen, Institute for Customer Insight
name: Annette Mönninghoff
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.