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

NCT06227247 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-05-05

Study results available
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Summary

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.

Conditions

  • Gestational Diabetes

Interventions

BEHAVIORAL

Meals4Moms Intervention

A community-based, healthy living program including continued gestational diabetes (GDM) education, physical activity level monitoring, and delivery of medically-tailored GDM meals for the management of gestational diabetes in pregnant people.

Sponsors & Collaborators

  • University of Connecticut

    collaborator OTHER
  • Trinity Health Of New England

    collaborator OTHER
  • Hartford Hospital

    collaborator OTHER
  • UConn Health

    lead OTHER

Principal Investigators

  • Andrea Shields, MD, MS · UConn Health

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-05
Primary Completion
2024-12-16
Completion
2025-01-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06227247 on ClinicalTrials.gov