Froedert & The Medical College of Wiscosin
Milwaukee, Wisconsin, 53226, United States
NCT Number: NCT06320054
The goal of this study is to learn whether access to healthy and fresh food, health coaching, and nutrition support intervention can reduce adverse birth outcomes in pregnant women. The main questions it aims to answer are:
* Does access to healthy and fresh food, health coaching and nutrition support reduce the risk of gestational diabetes or preeclampsia and ultimately improve health outcomes for mothers and their newborns? * Are participants able to successfully utilize the health program? Are participants satisfied and self-equipped to apply the teachings of the program within their lives following their participation in the study? Participants will be randomly assigned to one of two groups.
Participants in the standard of care will be asked to:
* Complete surveys * Biometric screenings
Participants in the intervention group will be asked to:
* Complete surveys * Biometric screenings * Participate in weekly personal health coaching * Receive and consume provided weekly meals.
Researchers will compare the standard of care to those who receive the intervention to see the impact of the intervention on clinical outcomes including: gestational weight gain, blood pressure, diagnosis of gestational diabetes, diagnosis of gestational hypertension or preeclampsia, and gestational age at birth.
This study is active but is not currently recruiting participants.
18 year–50 year
Female
Interventional
Not applicable
Milwaukee, Wisconsin, 53226, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Program participants will receive 10 fresh, local meals each week, delivered to their homes, health coaching including cooking and physical activity, biometrics screenings, and educational support to enable sustainable lifestyle change.
Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
gestational weight gain (BMI early pregnancy in comparison to BMI at delivery)
Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
blood pressure (Compared to early pregnancy, intrapartum, postpartum
Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Diagnosis of gestational diabetes
Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Diagnosis of preeclampsia or gestational hypertension
Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Gestational age at birth (Weeks and Days)
Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
program utilization (measured by percentage of weekly coaching attended and number of meals consumed)
Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
participant satisfaction and retention (measured by end of study evaluation)
Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
self-efficacy skills with meals preparation (as measured by nutrition survey)
Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
physical activity planning (as measured by physical activity survey)
Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Self-Efficacy (as measure by Self-Efficacy survey)
Medical College of Wisconsin
Other
Preventing Common Obstetric Complications Through an Immersive, Medically Tailored Meal Program
Acronym: PLATE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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