NCT06227247

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

Meals 4 Moms: Development and Feasibility of a Multilevel Community-based Lifestyle Intervention for Gestational Diabetes

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: UConn Health · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Gestational diabetes mellitus, or GDM, affects many pregnancies throughout the United States contributing to an increased risk of negative pregnancy outcomes such as delivery complications, hospitalizations, and poor clinical outcomes for both patients and infants. Additionally, many pregnant patients with GDM will progress to developing Type 2 diabetes within their lifetime. GDM, therefore, is the perfect window of opportunity for the prevention of diabetes. GDM management requires education and adoption of a specific diet, daily blood sugar monitoring, exercise, and compliance with prenatal visits. Adopting all these changes may be hard to understand and comply with in a short window of time as, on average, patients are diagnosed GDM 8 to 10 before delivery. Thus, to achieve these goals quickly, patients must have immediate access to nutrient-rich food, and on-going education and support regarding healthy-meal preparation, including portion sizes, frequency, and composition of healthy snacking. Previous and on-going research on health food prescription programs and supervised exercise sessions are often not performed with patients with GDM. To address this gap, investigators aim to develop a lifestyle intervention that promotes self-efficacy with unsupervised exercise and evidence-based behavioral strategies (e.g. goal setting, monitoring and feedback) and incorporate the use of physical activity tracking devices to support these strategies. This project has two distinct phases. First, to develop the novel Meals for Moms (M4M) community-based lifestyle intervention using feedback and input from women living with GDM. Second, to conduct a pilot feasibility randomized trial comparing the feasibility, compliance, and acceptability of the M4M intervention versus the usual care for pregnant persons diagnosed with GDM.

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-05
• Primary completion: 2024-12-16
• Completion: 2025-01-07
• First posted: 2024-01-26
• Last updated: 2026-02-17
• Results posted: 2026-02-17

Locations

1 site across 1 country: United States