UC Davis’ GROWell Intervention & Virtual Trial Powered by Pattern Health
GROWell is a study designed to learn whether a mobile health program can help women to have healthy pregnancies and return to pre-pregnancy health after giving birth. The GROWell program offers a digital behavioral intervention that delivers personalized messaging to support healthy eating behaviors during pregnancy and through six months postpartum. The GROWell intervention and virtual clinical trial are both powered by Pattern Health’s digital health platform.
Official Title: Goals for Reaching Optimal Wellness: GROWell
Study Type: Interventional (Clinical Trial) Estimated Enrollment: 480 participants
Investigator: Leigh Ann Simmons, Ph.D.
Professor & Chair
Department of Human Ecology
Most maternal-child health interventions focus on the health of the baby, and Dr. Simmons believes there is a gap to fill in terms of research-validated programs focused on maternal health. In 2017, she began piloting behavioral interventions for soon-to-be and recovering mothers through text messages. She found that healthy eating guidance could have a positive effect on maternal health.
In 2019, Dr. Simmons began the development of the GROWell program and the associated clinical trials. The GROWell intervention expanded upon her earlier research with a mobile app as the primary delivery method and data collection solution. The randomized, double-blind study was initially envisioned as a hybrid trial, but her needs transitioned to a fully-virtual trial design due to the COVID pandemic.
Dr. Simmons needed a technology partner to develop two solutions:
A mobile app to deliver the GROWell intervention and collect data
A platform to manage a completely virtual clinical trial
Finding A Partner
Dr. Simmons needed a partner that could accomplish her vision within a reasonable budget and time frame. She found vendors that could solve for mobile app development, text deployment, digital surveys, and virtual trial management, but each was a partial solution that would require her to make compromises and manage many separate projects. Pattern Health presented a unique set of capabilities that could support her end-to-end while meeting her budget and timeline requirements.
“I spoke to a number of companies that could partially meet my requirements, but they were very regimented. The Pattern Health solution & team impressed me with their flexibility and openness.”
-Dr. Leigh Ann Simmons
Pattern Health was an ideal fit for Dr. Simmons’ use case, offering the following:
Ability to deliver the intervention, collect data, and manage the virtual trial in one solution.
Existing integrations with a wide range of third-party services including best-of-breed solutions for biometrics, e-consent, patient recruitment, and more.
A flexible platform that could scale to support the project as it evolves in the future.
A track record of success supporting similar interventions and clinical trials.
Pattern Health worked with Dr. Simmons to develop and optimize a mobile application to deliver the GROWell behavioral intervention, and a platform to support a virtual clinical trial.
The study leverages Pattern Health’s integrations with StudyPages to create a seamless participant experience from recruitment, screening, consent, and enrollment. Once screened, participants are automatically enrolled and configured as study participants on the Pattern Health mobile app. After the enrollment process, participants become a part of the 12-month behavioral intervention program. The GROWell program delivers a personalized behavioral intervention that is detailed on the next page and it collects PROs and biometric data through surveys and integrated Bluetooth devices.
All data are collected centrally in Pattern Health’s platform which offers real-time reporting, API access, and manual exports for ease of reporting. Pattern Health is HITRUST certified and compliant with HIPAA, GDPR, and FISMA regulations to ensure data privacy and security. Additionally, Pattern Health is 21 CFR Part 11 compliant, meeting the FDA’s requirements for traceability, validation, assurance, and auditability.
“I can dream and count on Pattern Health to make it a reality.”
-Dr. Leigh Ann Simmons
GROWell Patient Experience
With self-regulation theory as the framework, the innovative GROWell intervention includes four components: (1) personalized goal setting, (2) daily support and educational messages, (3) self-monitoring of behavior with tailored feedback, and (4) skills training. Each component aligns with the self-regulatory processes shown in previous studies to be necessary for behavior change. All interactions with participants are via text using a cell phone.
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