Community-based lifestyle intervention for gestational diabetes management

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot feasibility trial compares a community-based lifestyle intervention called Meals for Moms (M4M) with usual care for pregnant individuals diagnosed with gestational diabetes (GDM). Participants will be randomly assigned to either the M4M program, which includes GDM education, physical activity monitoring, and delivery of tailored meals, or the usual care group. The study aims to assess the feasibility of the M4M intervention in managing GDM and improving health outcomes for both mothers and infants. The intervention focuses on providing immediate access to nutritious food and ongoing education to support healthy lifestyle changes during pregnancy.

Why it matters

Who can join: the full rules

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.

Where it's running

• UConn Health
  Farmington, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Andrea Shields, MD, MS — UConn Health
• Study coordinator: Makayla Murphy, MPH
• Email: makmurphy@uchc.edu
• Phone: 8606793331

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This project will see if sleep quality, anxiety, eating and activity habits, and metabolic markers relate to blood sugar control and birth outcomes in pregnant people with gestational diabetes.

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• Mobile-based obstetric monitoring for hypertension and diabetes during pregnancy

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  Recruiting at 3 sites Rutgers, The State University of New Jersey · Biratnagar and 2 other locations · NCT07243886

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.