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NCT Number: NCT07800078

Evaluation of a Wearable Technology to Support Breastfeeding Women

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.

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lokman Hekim University

Ankara, 06300, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Electrical Sensor Signals Obtained From the Wearable Prototype

    Time frame: During the 15-day intervention period

    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.

  2. Milk Flow Pattern Parameters Measured by the Wearable Sensor System

    Time frame: During the 15-day intervention period

    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.

  3. Expressed Breast Milk Volume Assessed Using the Breast Milk Expression Volume Record Form

    Time frame: During the 15-day intervention period

    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.

Secondary outcomes

  1. User Experience and Satisfaction Assessed Using the User Experience and Satisfaction Evaluation Form

    Time frame: At the end of the 15-day intervention period

    User experience and satisfaction will be assessed using the researcher-developed 14-item User Experience and Satisfaction Evaluation Form. Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 14 to 70, with higher scores indicating a more positive user experience and greater satisfaction with the wearable prototype and mobile application. The form also includes three open-ended questions to obtain additional qualitative feedback.

Sponsors and collaborators

Lead sponsor

Özlem Ülkü BULUT

Other Gov

Collaborators

  • Lokman Hekim University

Registry information

Official study title

Development of a Breast Milk-sensitive Wearable Technology and Evaluation of Its Effects Through the Experiences of Breastfeeding Women

Acronym: Lactogame

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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