NCT07555262

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
Dec 2025Jan 2027

Study Start

First participant enrolled

December 8, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

April 21, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

micro-randomized trialadherence

Outcome Measures

Primary Outcomes (1)

  • Meal Logging Adherence

    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 Outcomes (1)

  • Moderators of Reminder Responsiveness

    Assessed over 28 days

Study Arms (3)

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.

Behavioral: Loss-Framed Reminder

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.

Behavioral: Logging Consistency Reminder

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.

Behavioral: Neutral Reminder

Interventions

Push notification emphasizing loss of daily financial reward for not logging the upcoming meal.

Loss-Framed Reminder

Push notification providing feedback on recent meal logging streak.

Logging Consistency Reminder

Push notification reminding participants to log a meal.

Neutral Reminder (Active Control)

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HOCH Health and School of Medicine, University of St. Gallen

Sankt Gallen, Canton of St. Gallen, 9000, Switzerland

RECRUITING

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: Micro-randomized trial (MRT). Participants are randomized independently at each decision point (prior to each of 3 daily mealtimes) over 28 days, resulting in up to 84 randomizations per participant. At each decision point, participants are assigned with equal probability to one of three reminder conditions: loss-framed, logging consistency, or neutral control.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2026

First Posted

April 29, 2026

Study Start

December 8, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations