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临床试验/NCT04505124
NCT04505124已完成不适用

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

Annette Mönninghoff2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2020年11月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
95
试验地点
2
主要终点
Physical Activity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

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)).

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • <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

结局指标

主要结局

Physical Activity

时间窗: 12 weeks

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

Nutri-Score

时间窗: 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.

次要结局

  • Recovery Self-Efficacy(12 weeks)
  • Food Purchasing Behavior - Proteins(Continuous measurement during study (12 weeks))
  • Food Purchasing Behavior - Fruit & Vegetable Purchases(12 weeks)
  • Food Purchasing Behavior - Salt(12 weeks)
  • Food Purchasing Behavior - Saturated Fats(Continuous measurement during study (12 weeks))
  • User Engagement 2(12 weeks from beginning to end of intervention)
  • Perceived behavior-related control over future health(12 weeks)
  • User Engagement 1(12 weeks from beginning to end of intervention)
  • Food Purchasing Behavior - Sugar (excluding Fructose & Lactose)(12 weeks)
  • Autonomous Motivation(12 weeks)
  • Food Purchasing Behavior - Fibers(Continuous measurement during study (12 weeks))
  • Motivational Self-Efficacy(12 weeks)
  • Controlled Motivation(12 weeks)

研究者

发起方
Annette Mönninghoff
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Annette Mönninghoff

PhD Candidate and Project Leader

University of St.Gallen

研究点 (2)

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