Preventing Obstetric Complications With Dietary Intervention

Gestational Diabetes Clinical Trial

— PLATE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06320054
• Other study ID #: PRO00049771
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: March 2024
• Source: Medical College of Wisconsin
• Contact: Anna Palatnik, MD
• Phone: 414-805-6624
• Email: apalatnik[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Gestational Hypertension
• High Risk Pregnancy
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia
• Preeclampsia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Advancing a Healthier Wisconsin Endowment, Food for Health, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Outcomes	gestational weight gain (BMI early pregnancy in comparison to BMI at delivery)	End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Primary	Clinical Outcomes	blood pressure (Compared to early pregnancy, intrapartum, postpartum	End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Primary	Clinical Outcomes	Diagnosis of gestational diabetes	End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Primary	Clinical Outcomes	Diagnosis of preeclampsia or gestational hypertension	End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Primary	Clinical Outcomes	Gestational age at birth (Weeks and Days)	End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Secondary	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)
Secondary	Patient Reported Outcomes	participant satisfaction and retention (measured by end of study evaluation)	End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Secondary	Patient Reported Outcomes	self-efficacy skills with meals preparation (as measured by nutrition survey)	End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Secondary	Patient Reported Outcomes	physical activity planning (as measured by physical activity survey)	End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Secondary	Patient Reported Outcomes	Self-Efficacy (as measure by Self-Efficacy survey)	End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)