Search / Trial NCT06227247

Meals 4 Moms: A Multilevel Community-based Lifestyle Intervention for GDM

Launched by UCONN HEALTH · Jan 17, 2024

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

Diabetes Gestational Diabetes Pregnancy Exercise Nutrition Diabetes Education

ClinConnect Summary

The "Meals 4 Moms" trial is studying a new program aimed at helping pregnant women manage gestational diabetes (GDM), a type of diabetes that can occur during pregnancy. In this trial, women who are diagnosed with GDM will be randomly assigned to either continue with the usual care they receive or participate in the Meals for Moms program. This program offers education about gestational diabetes, tracks physical activity, and provides specially prepared meals designed for women with GDM. The goal is to see if this community-based approach is effective and practical for managing diabetes during pregnancy.

To be eligible for the trial, participants must be between 18 and 49 years old, currently pregnant with one baby, and diagnosed with GDM between 24 and 32 weeks of pregnancy. They should also be receiving care at specific health clinics in Connecticut and have access to the internet. Those who join the trial can expect to receive support and resources to help manage their condition, including meal deliveries. It’s important to note that participants need to be cleared by their healthcare provider to ensure they can safely engage in the program. This trial is currently recruiting participants, and taking part could be a valuable opportunity for women looking for additional help in managing gestational diabetes.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 18-49 years old
  • Current singleton pregnancy
  • GDM diagnosis between 24+0 and 31+6 weeks gestation, and no more than 4weeks from time of diagnosis at time of enrollment.
  • Currently receiving gestational diabetes management at the UConn Health Maternal Fetal Clinic, St. Francis's Hospital Women's Health clinic, Hartford Healthcare Women's Ambulatory Health Services (WAHS)
  • Intends to deliver at either UConn Health, St. Francis Hospital or Hartford Healthcare
  • Able to read and understand English well enough to participate in the study in English
  • Daily access to the internet from smartphone, tablet computer, or laptop/desktop computer that they can use to participate in the study
  • Medical clearance to participate from prenatal care provider including clearance to engage in physical activity
  • Able to provide verbal or written consent for each component of the study procedures and data collection
  • Currently lives within one of the meal delivery areas in Connecticut to allow for meal delivery (total of 32 eligible towns/cities)
  • Exclusion Criteria:
  • Unable or unwilling to give informed consent or communicate with study staff.
  • Diabetes mellitus (Type I or Type II).
  • GDM diagnosed prior to 24 weeks gestation or after 32+0 weeks gestation.
  • Patient is scheduled for a preterm delivery for medical reasons (i.e., placenta accreta, prior classical incision) at time of eligibility screening or at any time prior to randomization.
  • Concurrent participation in another research study providing intervention related to GDM, pregnancy, diet, and/or physical activity.
  • Medical conditions that may result in the inability to tolerate solid foods (i.e., hyperemesis gravidarum).
  • Medical condition which would prohibit participation as indicated by prenatal care provider providing medical clearance.
  • Dietary restrictions that cannot be accommodated for during meal preparation.
  • Currently does not live in one of the towns listed within the meal delivery area.
  • Has plans to move to out of the meal delivery area between enrollment and expected pregnancy due date.

Trial Officials

Andrea Shields, MD, MS

Principal Investigator

UConn Health

About Uconn Health

UConn Health, the University of Connecticut's academic medical center, is dedicated to advancing healthcare through innovative research and clinical trials. As a leading institution in medical education and patient care, UConn Health integrates cutting-edge scientific inquiry with community-focused healthcare services. With a robust portfolio of clinical trials spanning various therapeutic areas, UConn Health is committed to improving patient outcomes and enhancing the understanding of diseases through rigorous research methodologies. The center fosters collaboration among healthcare professionals, researchers, and patients to translate findings into practical applications, ultimately aiming to elevate the standard of care in the region and beyond.

Locations

Farmington, Connecticut, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0