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Search / Trial NCT06988306

Lifestyle Interventions to Prevent Diabetes in U.S. Home Visiting Programs

Launched by CALIFORNIA POLYTECHNIC STATE UNIVERSITY-SAN LUIS OBISPO · May 15, 2025

Trial Information

Current as of July 27, 2025

Not yet recruiting

Keywords

Medically Tailored Meals Gestational Diabetes Food Is Medicine Home Visiting

ClinConnect Summary

This clinical trial is looking at ways to help prevent diabetes in women who have had gestational diabetes mellitus (GDM), which is a type of diabetes that can occur during pregnancy. The study will involve nearly a thousand women who are either currently pregnant or have recently given birth. It will compare two different approaches during home visits: one group will receive both lifestyle support and tailored meals, while the other group will receive only the lifestyle support. The goal is to see if these interventions can help reduce the risk of developing diabetes and improve other health markers, such as weight and blood pressure, over a year after giving birth.

To be eligible for this study, women must be at least 18 years old, speak English or Spanish, and have been diagnosed with GDM in their most recent pregnancy. They should also be currently participating in home visiting services and not receiving medically tailored meals. Participants can expect support in making healthier lifestyle choices, and they will be randomly assigned to one of the two treatment groups. This is an important study that aims to improve health outcomes for women at risk of diabetes after pregnancy.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Currently in home visiting
  • Pregnant or \< 3 months (13 weeks) postpartum
  • Gestational Diabetes Mellitus diagnosis in most recent pregnancy (based on self-report)
  • Aged 18 years or older
  • English- or Spanish-speaking.
  • Not currently being given medically tailored meals
  • Willing to receive randomization to either group
  • Exclusion Criteria:
  • • Pre-existing diabetes (based on self-report)

About California Polytechnic State University San Luis Obispo

California Polytechnic State University, San Luis Obispo (Cal Poly) is a leading public research institution renowned for its commitment to hands-on learning and innovative research initiatives. With a focus on advancing knowledge across various scientific disciplines, Cal Poly actively engages in clinical trials that aim to improve healthcare outcomes and contribute to the understanding of complex medical issues. The university fosters collaboration among multidisciplinary teams, leveraging its academic resources and expertise to drive impactful research that benefits both the scientific community and society at large. Through its clinical trial sponsorship, Cal Poly demonstrates its dedication to advancing medical science and enhancing patient care.

Locations

Chicago, Illinois, United States

Providence, Rhode Island, United States

San Luis Obispo, California, United States

Patients applied

0 patients applied

Trial Officials

Suzanne Phelan, PhD

Principal Investigator

California Polytechnic State University-San Luis Obispo

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported