Status:
COMPLETED
Meals for Moms: Medically-Tailored Meals for Women Who Had Gestational Diabetes
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
North Carolina Diabetes Research Center
University of North Carolina, Chapel Hill
Conditions:
Diabetes, Gestational
Gestational Weight Gain
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this research study is to test whether delivery of medically tailored meals (meals designed specifically to be healthy) can be used to help reduce high blood sugar after delivery of a b...
Detailed Description
Pregnancy and delivery can function as a "stress test" for future development of cardiovascular disease and metabolic disorders, with gestational diabetes and excessive weight gain during pregnancy le...
Eligibility Criteria
Inclusion
- Demographics: Women 18 years of age and older who reside in Forsyth County, NC
- Pregnancy: Currently 24 or more weeks into a singleton pregnancy
- Clinical evidence of gestational diabetes mellitus (GDM) defined as either 3-hour oral glucose tolerance test (OGTT) results obtained in the second trimester of pregnancy that show at least 2 abnormal values or a diagnosis of "gestational diabetes" included on the Problem List in medical record during current pregnancy, regardless of OGTT values
- Excessive gestational weight gain: Most recent weight exceeds predicted weight gain for current weeks gestational age defined as pre-pregnancy Body mass index (BMI) of 30 kg/m2 or more and weight at most recent clinical visit 20+ pounds over pre-pregnancy weight or pre-pregnancy BMI of 25-29.9 kg/m2 and weight at most recent clinical visit 25+ pounds over pre-pregnancy weight
- English Proficiency: Able to read/understand English at or above a level sufficient to comprehend recruitment, informed consent, and intervention materials.
- Access to a smart phone/tablet/computer capable of connecting to video calls or teleconferencing software.
- Willingness to Accept Randomization: Prospective participants must be willing to accept randomization to either the medically tailored meal intervention or the comparison intervention condition.
Exclusion
- Clinical history of diabetes (type 1 or 2) pre-pregnancy
- Non-singleton pregnancy
- Other chronic diseases or medical conditions that would increase risk or make participation otherwise unsafe, including special dietary needs. A clinician investigator will review the medical record for all potential participants to determine if any such conditions exist.
- Known food allergies of sensitivities. Potential participants who report special dietary requirements including vegetarians, vegans, those who follow kosher or other specialized diets will be excluded due to the small nature of this pilot study.
- History of allergic skin reaction to adhesive tape
- Unable or unwilling to wear a continuous glucose monitor (CGM) device
- Is scheduled for an MRI during the study weeks, making use of the CGM device unsafe
- Other: Conditions/criteria likely to interfere with participation and acceptance of randomized assignment, including the following: inability/unwillingness to give informed consent, major psychiatric or cognitive problems (schizophrenia, dementia, self-reported substance or alcohol abuse), participation in another research study that would interfere with Meals for Moms
Key Trial Info
Start Date :
October 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04866823
Start Date
October 20 2021
End Date
January 17 2023
Last Update
April 29 2025
Active Locations (1)
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1
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27101