RECRUITING

Preventing Obstetric Complications With Dietary Intervention

Conditions

Gestational Diabetes Gestational Hypertension High Risk Pregnancy Preeclampsia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-12

Study Completion:2025-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06320054

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Anna Palatnik, MD

CONTACT

414-805-6624

apalatnik@mcw.edu

Amandla Stanley, MSN

CONTACT

414-805-6691

akstanley@mcw.edu

Principal Investigator

Anna Palatnik, MD

PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Study Locations (Sites)

Froedert & The Medical College of Wiscosin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

Anna Palatnik, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-12

Study Completion Date2025-08-31

Study Record Updates

Study Start Date2024-06-12

Study Completion Date2025-08-31

Terms related to this study

Additional Relevant MeSH Terms

Gestational Diabetes
Gestational Hypertension
High Risk Pregnancy
Preeclampsia