Preventing Obstetric Complications With Dietary Intervention (PLATE)

Preventing Common Obstetric Complications Through an Immersive, Medically Tailored Meal Program

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Preeclampsia; Gestational Diabetes; High Risk Pregnancy; Gestational Hypertension
• Intervention / Treatment: Behavioral: Maternal Health Management Program

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Palatnik, MD; Phone Number: 414-805-6624; Email: apalatnik@mcw.edu
• Study Contact Backup: Name: Amandla Stanley, MSN; Phone Number: 414-805-6691; Email: akstanley@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

1. Age at enrollment ≥ 18 years of age
2. Receiving prenatal care at Froedtert
3. ≤ 16 weeks and 6 days of gestation
4. At risk of preeclampsia, defined as being eligible for low dose aspirin treatment AND/OR at risk for gestational diabetes defined as having a history of gestational diabetes, OR previously given birth to an infant weighing ≥ 4000 g, OR has a diagnosis of PCOS
5. Pre-pregnancy Body Mass Index ≥ 25 kg/m^2
6. Resides in Milwaukee County at time of consent
7. Low socio-economic status (<200% of FPL defined as receiving Medicaid)
8. Able to read and communicate in English
9. Has access to a smart device/computer with reliable internet connection
10. Has access to a working refrigerator
11. Viable singleton pregnancy

Exclusion criteria:

1. Diagnosed with Type I or Type II Diabetes or Hemoglobin A1C ≥ 6.5%
2. Diagnosed with End Stage Renal Disease
3. Use of weight-increasing psychotropic agents
4. Active inflammatory bowel disease, or history of bowel resection or malabsorptive syndrome, or history of bariatric surgery
5. Significant food allergies, preferences or dietary requirements that would interfere with diet adherence
6. Multifetal gestation
7. Active substance use that would preclude program adherence
8. Chronic use of oral corticosteroids
9. Unable to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Prenatal Care; Standard Prenatal Care, biometric screenings, and surveys (baseline, 4-12 weeks postpartum).
Experimental: Maternal Health Management Program; 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.	Behavioral: Maternal Health Management Program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcomes	gestational weight gain (BMI early pregnancy in comparison to BMI at delivery)	End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Clinical Outcomes	blood pressure (Compared to early pregnancy, intrapartum, postpartum	End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Clinical Outcomes	Diagnosis of gestational diabetes	End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Clinical Outcomes	Diagnosis of preeclampsia or gestational hypertension	End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Clinical Outcomes	Gestational age at birth (Weeks and Days)	End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcomes	program utilization (measured by percentage of weekly coaching attended and number of meals consumed)	End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Patient Reported Outcomes	participant satisfaction and retention (measured by end of study evaluation)	End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Patient Reported Outcomes	self-efficacy skills with meals preparation (as measured by nutrition survey)	End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Patient Reported Outcomes	physical activity planning (as measured by physical activity survey)	End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Patient Reported Outcomes	Self-Efficacy (as measure by Self-Efficacy survey)	End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Advancing a Healthier Wisconsin Endowment; Food for Health, Inc.
• Investigators: Principal Investigator: Anna Palatnik, MD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Hypertension; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pre-Eclampsia; Diabetes, Gestational; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: PRO00049771

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No