Jovie Study 1.3

The Jovie Study platform, developed by ObvioHealth, serves as a specialized digital tool designed to facilitate the management of a clinical trial investigating the effects of an investigational infant formula on infant growth and tolerance. This platform enables direct engagement with participants' mobile devices, streamlining data collection and reducing logistical complexity.

By leveraging mobile technology, the Jovie app eliminates the need for frequent physical site visits, thereby offering a more efficient approach to clinical research. This method has demonstrated advantages such as comprehensive data capture, enhanced participant adherence, accelerated study timelines, and an estimated cost reduction of approximately 50% compared to traditional on-site trials.

Subject Enrollment: Participants deemed eligible during pre-screening are invited via email to download the Jovie app. Upon installation, participants are guided through the account creation process and complete an informed consent. The app provides clear explanations regarding:

• Privacy Policy
• Data Collection and Usage
• Study Tasks and Surveys
• Time Commitment
• Right to Withdraw

The platform allows participants to connect with study personnel for questions prior to providing consent, ensuring clarity and informed decision-making.

Intervention Period: Daily Data Collection Tasks Throughout a 5-day baseline phase followed by a 16-week active trial, participants will complete questionnaires and upload data as instructed. They have the option to communicate securely with the study team through real-time chat functionalities as needed.