- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07555262
Reminder Strategies to Improve Meal-Logging Adherence
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mia Jovanova, Dr.
- Phone Number: +41 44 632 05 41
- Email: mia.jovanova@unisg.ch
Study Locations
-
-
Canton of St. Gallen
-
Sankt Gallen, Canton of St. Gallen, Switzerland, 9000
- Recruiting
- HOCH Health and School of Medicine, University of St. Gallen
-
Contact:
- Mia Jovanova, Dr.
- Phone Number: +41 44 632 05 41
- Email: mia.jovanova@unisg.ch
-
Principal Investigator:
- Mia Jovanova, Dr.
-
Principal Investigator:
- Tobias Kowatsch, Prof.Dr.
-
Principal Investigator:
- Michael Brändle, Prof.Dr.med
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Loss-Framed Reminder
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.
|
Push notification emphasizing loss of daily financial reward for not logging the upcoming meal.
|
|
Experimental: Logging Consistency Reminder
A push notification providing feedback on the participant's recent meal logging streak.
Assigned with 1/3 probability at each decision point.
|
Push notification providing feedback on recent meal logging streak.
|
|
Active Comparator: Neutral Reminder (Active Control)
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.
|
Push notification reminding participants to log a meal.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Meal Logging Adherence
Time Frame: 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).
|
Within 2 hours of each decision point, assessed over 28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Moderators of Reminder Responsiveness
Time Frame: Assessed over 28 days
|
Meal logging adherence (binary, within 2 hours of a decision point) examined as a function of participant-level moderators including physiological (e.g., heart rate variability), demographic (e.g., age, sex), and behavioral characteristics, to identify moderators of differential responsiveness to reminder types.
|
Assessed over 28 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLOWUP-MRT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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