Preventing Obstetric Complications With Dietary Intervention

NCT06320054 | Recruiting

• 1 other identifier: PRO00049771
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gestational Diabetes; Gestational Hypertension; High Risk Pregnancy; Preeclampsia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Patient Reported Outcomes

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

• Patient Reported Outcomes

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

• Patient Reported Outcomes

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

• Patient Reported Outcomes

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

• Patient Reported Outcomes

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

Study Arms (2)

Standard Prenatal Care

NO INTERVENTION

Standard Prenatal Care, biometric screenings, and surveys (baseline, 4-12 weeks postpartum).

Maternal Health Management Program

EXPERIMENTAL

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

Interventions

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.

Maternal Health Management Program

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Advancing a Healthier Wisconsin Endowment: collaborator
• Food for Health, Inc.: collaborator

Study Sites (1)

Froedert & The Medical College of Wiscosin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Hypertension, Pregnancy-Induced; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anna Palatnik, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Palatnik, MD

CONTACT

414-805-6624; apalatnik@mcw.edu

Amandla Stanley, MSN

CONTACT

414-805-6691; akstanley@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 20, 2024
• Study Start: June 12, 2024
• Primary Completion: February 28, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)