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Идёт набор NCT07555262

Reminder Strategies to Improve Meal-Logging Adherence

Без фазы С лечением Patient Compliance Mobile Applications Reminder Systems

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Loss-Framed Reminder, Logging Consistency Reminder, Neutral Reminder.
Кому может быть актуально
Состояния в реестре: Patient Compliance, Mobile Applications, Reminder Systems. Базовые параметры: от 45 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

  • Поведенческое Loss-Framed Reminder
    Push notification emphasizing loss of daily financial reward for not logging the upcoming meal.
  • Поведенческое Logging Consistency Reminder
    Push notification providing feedback on recent meal logging streak.
  • Поведенческое Neutral Reminder
    Push notification reminding participants to log a meal.

Первичные конечные точки

  • Meal Logging Adherence [Срок оценки: Within 2 hours of each decision point, assessed over 28 days]
Вторичные конечные точки (1)
  • Moderators of Reminder Responsiveness [Срок оценки: Assessed over 28 days]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Швейцария · 1 центр
  • HOCH Health and School of Medicine, University of St. Gallen — Sankt Gallen

Идентификаторы

NCT: NCT07555262 · GLOWUP-MRT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗