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Food Program for Pregnancy Complications

N/A

Recruiting

Research Sponsored by Christiana Care Health Services

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years or older

4 to 14 weeks pregnant

Must not have

Current diagnosis of type 1 or type 2 diabetes

Not able to store and prepare meals

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from delivery date to hospital discharge date, assessed up to 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a program called the Women's Health Delaware Food Farmacy to see if it can help pregnant ChristianaCare patients who are at risk for health problems. The study has three goals:

Who is the study for?

This trial is for pregnant women receiving care at ChristianaCare who are at risk of complications like high blood pressure, gestational diabetes, eclampsia, pre-eclampsia, or obesity. Specific eligibility details aren't provided but typically include factors like age and health status.

What is being tested?

The study is testing a 'Food is Medicine' program by Women's Health Delaware Food Farmacy against the standard healthcare pregnant women usually receive. It aims to see if this program can improve maternal and child health outcomes.

What are the potential side effects?

Since this trial involves a food-based intervention rather than medication, side effects may not be as common as in drug trials. However, potential side effects could include food-related allergies or intolerances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am between 1 and 3 months pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with diabetes.

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I cannot store or prepare my own meals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body Mass Index

Cesarean Delivery

Emergency Room Visit

+19 more

Secondary study objectives

Cost-Related Medication Underuse

Dietary Intake

Food Insecurity

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Women's Health Delaware Food FarmacyExperimental Treatment1 Intervention

Participants will receive medically tailored groceries (10 meals per person in the household per week from enrollment to 4 weeks after delivery) high in micronutrients that are delivered to their homes weekly. They will also interact weekly with their assigned Community Health Worker to address social needs and patient-centered goals.

Group II: Usual Standard of CareActive Control1 Intervention

Participants will receive the usual standard of care.

0 / 4Eligibility criteria met