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NCT04866823 · ClinicalTrials.gov registry record · NA
Meals for Moms: Medically-Tailored Meals for Women Who Had Gestational Diabetes
A NA study of Gestational Weight Gain and Postpartum Weight Retention, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT04866823: Completed NA study of Gestational Weight Gain and Postpartum Weight Retention, sponsored by Wake Forest University Health Sciences.
NCT04866823 is a NA study of Gestational Weight Gain and Postpartum Weight Retention that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 12 participants, below the 492-participant average among 7 other Gestational Weight Gain trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04866823, a NA study of Gestational Weight Gain and Postpartum Weight Retention, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Determine the percent of meals successfully ordered \& delivered in the intervention group
Conditions Studied
Interventions
- BEHAVIORAL Medically Tailored Meals
Study Locations (1)
North Carolina
- Wake Forest Baptist Health - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-10-20 |
| Est. Completion | 2023-01-17 |
| Phase | NA |
What the finished NCT04866823 record still lists
NCT04866823 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 492-participant average among 7 other Gestational Weight Gain trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Gestational Weight Gain appearing as the primary indexed condition, and to 1 intervention - of which Medically Tailored Meals is the first listed.
NCT04866823 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04866823 about?
NCT04866823 is a clinical study titled "Meals for Moms: Medically-Tailored Meals for Women Who Had Gestational Diabetes". 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 b...
What is the current status of trial NCT04866823?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2021-10-20. Estimated completion is 2023-01-17.
What conditions does trial NCT04866823 study?
This clinical trial studies the following conditions: Gestational Weight Gain, Postpartum Weight Retention, Diabetes, Gestational.
What interventions are being tested in trial NCT04866823?
The interventions under investigation include: Medically Tailored Meals (BEHAVIORAL).
Who is sponsoring clinical trial NCT04866823?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04866823 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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