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Food is Medicine Program for Pregnant Women

This study is testing if the Women's Health Delaware Food Farmacy program can help pregnant women at risk for health problems like pre-eclampsia (high blood pressure during pregnancy), obesity, gestational diabetes (diabetes during pregnancy), and gestational hypertension (high blood pressure during pregnancy). You could join if you are a ChristianaCare Women's Health patient, 18 or older, 4 to 14 weeks pregnant with one baby, have Medicaid, a BMI of 30 or higher, and live in New Castle County. The study will look at changes in social determinants of health (factors like food access or housing), gestational weight gain, and Body Mass Index (BMI) from the start of the study to 2-6 weeks after delivery. The current recruitment status is unclear.

Study design
This is a pilot randomized controlled trial with 250 participants. Participants will be randomly assigned to either receive the Women's Health Delaware Food Farmacy program or usual standard of care.
What's involved
If you are in the Food Farmacy group, you will receive weekly home-delivered groceries and interact weekly with a Community Health Worker from enrollment to 4 weeks after delivery. All participants will complete questionnaires at the start and after delivery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed until 2-6 weeks after delivery for primary endpoints.

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NCT06180811

Evaluating the Effectiveness of a Food is Medicine Community Health Worker Program for Pregnant Women

UNKNOWN
NAAges 18+InterventionalTreatment
Christiana Care Health Services
~250 participants
Updated 2024-05-06 on ClinicalTrials.gov
What's tested:Women's Health Delaware Food FarmacyUsual Standard of Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Social Determinants of Health
Measured over Changes from baseline to 2-6 weeks after delivery
+21 more outcomes measured

Conditions

Pre-Eclampsia
Obesity
Gestational Diabetes
Gestational Hypertension

Explore related trials

Gestational DiabetesGestational HypertensionObesityPreeclampsia

Where it's being run

1 sites across 1 states
Delaware1

Who to contact

Kathleen McCallops, PhD
[email protected]
3024286590
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

ChristianaCare Women's Health patient
18 years or older
4 to 14 weeks pregnant
Singleton pregnancy
Medicaid
BMI of 30 or higher
Reside in New Castle County

Exclusion

Current diagnosis of type 1 or type 2 diabetes
Multiple pregnancy
Currently enrolled in another Community Health Worker program
Not able to store and prepare meals
Diagnosed with severe medical comorbidities that might interfere with their ability to participate in the intervention, such as severe psychiatric illness or imminent hospitalization
Not able to understand and communicate effectively in English or Spanish

What this trial measures

  • Social Determinants of HealthChanges from baseline to 2-6 weeks after delivery

    Measured with ChristianaCare Social Determinants of Health Screener; Number of socials needs range from 0-11, higher scores indicate greater number of social needs

  • Gestational Weight GainChanges from baseline to 2-6 weeks after delivery

    Observed gestational weight gained

  • Body Mass IndexChanges from baseline to 2-6 weeks after delivery

    Observed body mass index changes

  • Gestational DiabetesFrom baseline to delivery

    Occurrence of gestational diabetes

  • Gestational HypertensionFrom baseline to delivery

    Occurrence of gestational hypertension

  • Systolic and Diastolic Blood PressureChanges from baseline to 2-6 weeks after delivery

    Observed systolic and diastolic blood pressure

  • PreeclampsiaFrom baseline to 2-6 weeks after delivery

    Occurrence of preeclampsia and week diagnosed during pregnancy

  • HydramniosFrom baseline to delivery

    Occurrence of hydramnios

  • Gestational AgeAt delivery

    Baby's gestational age at birth

  • Small for Gestational AgeAt delivery

    Birth weight less than 10th percentile based on gestational age

  • Preterm BirthAt delivery

    Preterm birth less than 37 weeks

  • Fetal MacrosomiaAt delivery

    Birth weight greater than 90th percentile based on gestational age

  • Cesarean DeliveryAt delivery

    Occurrence of cesarean delivery including those planned and unplanned

  • Fetal DeathFrom baseline to delivery

    Occurrence of fetal death

  • NICU AdmissionWithin 48 hours after delivery

    Occurrence of NICU admission for any reason

  • NICU Length of StayFrom NICU admission date to NICU discharge date, assessed up to 90 days

    Number of days baby was admitted to NICU

  • Maternal Length of StayFrom delivery date to hospital discharge date, assessed up to 90 days

    Number of days hospitalized following delivery

  • Postpartum AdmissionFrom delivery discharge to 90 days after

    Number of postpartum hospital admissions for any reason

  • Postpartum Admission Length of StayFrom postpartum admission date to hospital discharge date, assessed up to 90 days

    Number of days hospitalized

  • Hospital AdmissionFrom baseline up to delivery

    Number of hospital admissions for any reason

  • Hospital Admission Length of StayFrom admission date to hospital discharge date, assessed up to 90 days

    Number of days hospitalized

  • Emergency Room VisitFrom baseline to 90 days after delivery

    Number of emergency room visits for any reason