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

Stopped early · Not applicable

Conditions studied: Gestational Diabetes

In brief

The goal of the project is to conduct a pilot feasibility randomized trial comparing a community-based lifestyle intervention called Meals for Moms (M4M) versus the usual care for pregnant persons diagnosed with gestational diabetes (GDM). Participants will be randomly placed into the usual care (UC) comparison group or the M4M healthy living program, which includes continued GDM education, physical activity level monitoring, and delivery of medically-tailored GDM meals. The trial will assess if M4M is feasible for the management of gestational diabetes in pregnant patients.

Key facts

Study ID

NCT06227247

Run by

UConn Health

People needed

8

Starts

2024-03-05

Expected to finish

2025-01-07

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older, up to 49. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 is running

• UConn Health — Farmington, Connecticut, United States

Full record on ClinicalTrials.gov

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