Community-based lifestyle intervention for gestational diabetes management
Meals 4 Moms: Development and Feasibility of a Multilevel Community-based Lifestyle Intervention for Gestational Diabetes
This study is testing a new program that provides education and healthy meals to help pregnant people with gestational diabetes manage their condition better than with standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | Female |
| Sponsor | UConn Health Academic / other |
| Locations | 1 site (Farmington, Connecticut) |
| Trial ID | NCT06227247 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals aged 18-49 who have been diagnosed with gestational diabetes between 24 and 31 weeks of gestation.
Not a fit: Patients who are not currently receiving gestational diabetes management or those who do not live within the meal delivery areas may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the management of gestational diabetes, leading to better health outcomes for mothers and their infants.
How similar studies have performed: Previous studies on health food prescription programs and supervised exercise have shown promise, but this specific approach for GDM management is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Farmington, Connecticut
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.