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OpenTrials
Active, Not Recruiting

NCT Number: NCT06320054

Preventing Obstetric Complications With Dietary Intervention

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age at enrollment ≥ 18 years of age
  • Receiving prenatal care at Froedtert
  • ≤ 16 weeks and 6 days of gestation
  • 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
  • Pre-pregnancy Body Mass Index ≥ 25 kg/m^2
  • Resides in Milwaukee County at time of consent
  • Low socio-economic status (<200% of FPL defined as receiving Medicaid)
  • Able to read and communicate in English
  • Has access to a smart device/computer with reliable internet connection
  • Has access to a working refrigerator
  • Viable singleton pregnancy

Exclusion criteria

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

Treatment and study plan

Maternal Health Management Program

Behavioral

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.

Primary outcomes

  1. Clinical Outcomes

    Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)

    gestational weight gain (BMI early pregnancy in comparison to BMI at delivery)

  2. Clinical Outcomes

    Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)

    blood pressure (Compared to early pregnancy, intrapartum, postpartum

  3. Clinical Outcomes

    Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)

    Diagnosis of gestational diabetes

  4. Clinical Outcomes

    Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)

    Diagnosis of preeclampsia or gestational hypertension

  5. Clinical Outcomes

    Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)

    Gestational age at birth (Weeks and Days)

Secondary outcomes

  1. Patient Reported Outcomes

    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)

  2. Patient Reported Outcomes

    Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)

    participant satisfaction and retention (measured by end of study evaluation)

  3. Patient Reported Outcomes

    Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)

    self-efficacy skills with meals preparation (as measured by nutrition survey)

  4. Patient Reported Outcomes

    Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)

    physical activity planning (as measured by physical activity survey)

  5. Patient Reported Outcomes

    Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)

    Self-Efficacy (as measure by Self-Efficacy survey)

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Advancing a Healthier Wisconsin Endowment
  • Food for Health, Inc.

Registry information

Official study title

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

Acronym: PLATE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2024
Registry last updated
Jul 20, 2026

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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