Evaluation of a Wearable Technology to Support Breastfeeding Women

NCT07800078 | Not Yet Recruiting

• 1 other identifier: LactoGameWear01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate a wearable technology developed to support breastfeeding women. The study will assess the performance of sensors in the wearable prototype for monitoring breast milk fullness and milk flow and compare the sensor measurements with the amount of breast milk obtained through breast pumping. The study will also evaluate women's experiences, satisfaction, perceived usefulness, and ease of use of the wearable prototype and its mobile application. The technology is intended for monitoring and support purposes and will not be used for diagnosis, treatment, or clinical decision-making.

Conditions

Breastfeeding

Keywords

Wearable Technology; Breast Milk; Breastfeeding Support; Digital Health; Milk Flow; User Experience

Outcome Measures

Primary Outcomes (3)

• Electrical Sensor Signals Obtained From the Wearable Prototype

  The wearable sensor system will acquire and analyze sensor signals to generate a Breast Milk Fullness Index ranging from 0 to 100. Higher values indicate greater estimated breast milk fullness. Measurements will be obtained in relation to breastfeeding and/or breast pumping sessions and compared with reference measurements of milk removal.

  During the 15-day intervention period

• Milk Flow Pattern Parameters Measured by the Wearable Sensor System

  Milk flow-related signal patterns will be acquired and analyzed by the LactoGame wearable sensor system during breastfeeding and/or breast pumping. Quantitative system-derived parameters, including average and peak signal characteristics, will be used to characterize milk flow patterns.

  During the 15-day intervention period

• Expressed Breast Milk Volume Assessed Using the Breast Milk Expression Volume Record Form

  Expressed breast milk volume will be recorded using the Breast Milk Expression Volume Record Form. For each pumping session, the amount of breast milk obtained will be recorded in milliliters (mL), together with breast side, expression method, and expression duration. Expressed milk volume will be used as a reference measurement for comparison with sensor-derived measurements.

  During the 15-day intervention period

Secondary Outcomes (1)

• User Experience and Satisfaction Assessed Using the User Experience and Satisfaction Evaluation Form

  At the end of the 15-day intervention period

Study Arms (1)

Wearable Breastfeeding Support Technology

EXPERIMENTAL

Participants will use the wearable prototype and its accompanying mobile application. Sensor measurements obtained during use will be evaluated and compared with the amount of breast milk obtained through breast pumping. Participants' experiences with the technology will also be assessed.

Device: Breast Milk-Sensitive Wearable Technology

Interventions

Breast Milk-Sensitive Wearable Technology DEVICE

Participants will use a breast milk-sensitive wearable prototype integrated with a mobile application. The wearable technology collects sensor-based measurements related to breast milk fullness and milk flow. Sensor measurements will be compared with the amount of breast milk obtained through breast pumping. Participants' experiences, satisfaction, perceived usefulness, and ease of use of the wearable technology and mobile application will also be evaluated.

Wearable Breastfeeding Support Technology

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18-45 years
• Currently breastfeeding
• Having an infant aged 0-6 months
• Willing to use the wearable technology and accompanying mobile application for 15 days
• Able to express breast milk for comparison with sensor measurements
• Voluntarily agreeing to participate in the study

You may not qualify if:

• Having a medical condition that prevents breastfeeding or breast milk expression
• Having an active breast or nipple condition that prevents the use of the wearable prototype
• Being unable to use the wearable technology or mobile application during the study period
• Withdrawing consent at any stage of the study

Sponsors & Collaborators

• Özlem Ülkü BULUT: lead
• Lokman Hekim University: collaborator

Study Sites (1)

Lokman Hekim University

Ankara, Ankara, 06300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Profesor

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 2, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)