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Clinical Trial Details
Meals 4 Moms: Development and Feasibility of a Multilevel Community-based Lifestyle Intervention for Gestational Diabetes
Clinical Trial ( IRB ) #: 23-190SSF-2
Title: Meals 4 Moms: Development and Feasibility of a Multilevel Community-based Lifestyle Intervention for Gestational Diabetes
Principal Investigator: Dr. Andrea Shields
Description: Gestational Diabetes Mellitus (GDM) affects 2-10% of pregnancies in the US and 50% of GDM patients will progress to develop Type II Diabetes Mellitusin their lifetime. GDM can also cause pregnancy complications including antepartum hospitalization, cesarean delivery and longer length of stay during antepartum or delivery admissions. Improving pregnancy outcomes involves patients understanding and adopting to an ADA specific diet, daily glucose monitoring and physical activity and compliance with prenatal visits. Providing education during pregnancy is the optimal window of opportunity for the prevention of diabetes. In Phase 1 of the study, the team of investigators will develop a novel, personalized lifestyle intervention (Meals 4 Moms Bundle) for pregnant patients diagnosed with GDM to supplement the usual care and education that is provided to such patients. The bundle will include additional GDM education, nutrition and exericse guidance, GDM meal kit delivery and support. Prior to implementation of the bundle, focus groups (with current GDM patients) to solicit feedback on the bundle materials will be conducted. Phase 2 of the study will involve a pilot feasibility randomized clinical trial which includes UConn Health patients diagnosed with GDM. Patients will be randomly assigned to receive usual obstetrics care for patients who are diagnosed with GDM or usual care plus the Meals 4 Mom Bundle. The clinical trial will assess the feasibility and acceptability outcomes of recruitment rate, retention, adherence to diet and exercise recommendations and acceptability with the program.
Classification:
  Obstetrics and Gynecology
Eligibility Criteria: Check with study contact
How to Contact: Kristen Annis. Telephone: 860-679-3812. Email: annis@uchc.edu
Enrollment Status/Comments: Enrolling/recruiting. For current recruitment status, please check with study contact.