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临床试验/NCT07555262
NCT07555262招募中不适用

Reminder Strategies to Improve Meal-Logging Adherence

University of St.Gallen1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年12月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Meal Logging Adherence

研究概览

简要总结

This study is a single-center micro-randomized trial, aiming to examine the effects of two theory-driven reminder strategies on adherence to repeated, image-based meal logging in adults age 45 and older. Three times daily, participants are automatically randomized to receive one of three reminder messages prior to each habitual mealtime. The main research questions the trial aims to answer are:

  • Do loss-framed reminders (emphasizing loss of a daily financial reward for not logging) increase meal logging adherence in the two hours following a reminder, compared to a neutral reminder?
  • Do logging consistency reminders (providing feedback on recent logging streaks) increase meal logging adherence in the two hours following a reminder, compared to a neutral reminder?
  • Do the effects of loss-framed and logging consistency reminders differ from each other?

Primary aim: To estimate the proximal effect of each reminder type on whether a participant logs a meal within two hours of receiving a reminder.

Secondary aim: To examine whether within-person physiological patterns (e.g., heart rate variation) moderate response to reminders, with the goal of identifying physiological markers of receptivity to behavioral prompts.

The trial aims to enroll 200 adults aged 45 and older. Participants attend a baseline visit for onboarding, consent, and device setup, followed by a 28 day remote intervention period during which they should photograph their meals three times daily (breakfast, lunch, dinner) and wear a smartwatch and smart ring continuously. Prior to each mealtime, they receive an automatically randomized reminder message. Participants earn a daily financial reward contingent on completing meal logging for that day.

Note: This trial was registered retrospectively as enrollment began prior to registration. However, registration was completed before data collection was finished and before any data analysis was conducted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Citizens or residents of Switzerland who are German-speaking (main place of living or employment in Switzerland).
  • Age ≥45 years.
  • BMI ≥25 kg/m² (overweight or obese).
  • Regular access to a smartphone (iOS or Android) with a data plan.
  • Able to use smartphone applications.
  • Able to walk independently.

排除标准

  • History of stroke, heart disease, renal failure, cancer, or diabetes (type 1 or type 2).
  • Past vascular bypass surgery or angioplasty.
  • Current or planned use of glucose-lowering medications during the upcoming 4 weeks (e.g., GLP-1 receptor agonists, metformin).
  • Pregnant or breastfeeding.
  • Relevant skin conditions at wearable placement sites (e.g., upper arm).
  • BMI <25 kg/m² confirmed at enrollment.
  • FPG ≥7.0 mmol/L and/or HbA1c ≥6.5% (newly identified type 2 diabetes); Individuals who meet type-2 diabetes criteria at enrollment, based on Swiss/ADA diagnostic criteria will be informed of blood test results and referred to a GP. These individuals will be deemed ineligible and excluded from the study.

研究组 & 干预措施

Neutral Reminder (Active Control)

Active Comparator

A push notification reminding the participant to log a meal without loss-framing or consistency feedback. Serves as the reference condition against which the two experimental reminders are compared. Assigned with 1/3 probability at each decision point.

干预措施: Neutral Reminder (Behavioral)

Loss-Framed Reminder

Experimental

A push notification emphasizing the loss of a daily financial reward for not logging the upcoming meal. Assigned with 1/3 probability at each decision point.

干预措施: Loss-Framed Reminder (Behavioral)

Logging Consistency Reminder

Experimental

A push notification providing feedback on the participant's recent meal logging streak. Assigned with 1/3 probability at each decision point.

干预措施: Logging Consistency Reminder (Behavioral)

结局指标

主要结局

Meal Logging Adherence

时间窗: Within 2 hours of each decision point, assessed over 28 days

Proportion of decision points at which a participant logs a meal within 2 hours of receiving a reminder, compared across reminder types (loss-framed, logging consistency, and neutral control).

次要结局

  • Moderators of Reminder Responsiveness(Assessed over 28 days)

研究者

发起方
University of St.Gallen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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