N/A
N=12
Meals for Moms: Medically-Tailored Meals for Women Who Had Gestational Diabetes
Diabetes, Gestational · Gestational Weight Gain · Postpartum Weight Retention
Bottom Line
View on ClinicalTrials.gov: NCT04866823 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Number of Meals Successfully Ordered and Delivered — 2880 meals
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Medically Tailored Meals (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Meals Successfully Ordered and Delivered |
2880 | — |
| PRIMARY Number of Dollars Cost |
1800.0 | — |
| PRIMARY Days of Continuous Glucose Monitoring in Postpartum Mothers |
11.43 | — |
| PRIMARY Days of Continuous Glucose Monitoring in Postpartum Mothers |
11.43 | — |
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 baby. Participants will be recruited and consented during the third trimester of pregnancy but will begin study activities after delivery. Participants will complete a series of questionnaires on demographics, health history, home environment, overall and financial stress, plans for weight loss and infant feeding, and food insecurity. Participants will also be asked to wear continuous glucose monitors for two separate 14-day periods (within 2 weeks of delivery and at 3 months). All participants will receive weekly emails with educational videos and 3 virtual visits with a member of the study team and will also be randomly assigned to an intervention or comparison group. In the intervention, participants will receive weekly meal deliveries of 10 pre-prepared meals from Providence Community Kitchen (local company in Winston-Salem, NC) that are calorically restricted and appropriate for post-partum women with a history of gestational diabetes and who may be breast-feeding. Women in the control condition will receive written resources on self-care, nutrition, and physical activity appropriate for post-partum women who had gestational diabetes.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04866823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.