Gestational Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to assess the effectiveness of a Food is Medicine (FIM) intervention on incidence of gestational diabetes mellitus (GDM) among pregnant women at risk for GDM within the Harris Health system.
Interventions
BEHAVIORALStandard of Care
Standard medical care provided at Harris Health for high-risk pregnant women, plus a voucher equal to the value of the produce and meals provided in the Food is Medicine (FIM) Intervention.
BEHAVIORALFood is Medicine (FIM) Intervention
Intensive intervention phase - this phase starts at enrollment (\<=14 weeks) through 28 weeks of gestation (or at the time of GDM diagnostic test) and women i) receive a bi-weekly home delivery of a mixed box consisting of fresh produce, lean protein, and whole grains combined with culinary medicine-based nutrition education available in English and Spanish. Maintenance phase - this phase starts at 29 weeks through 12 weeks postpartum, and women will receive biweekly deliveries of about 10-15 pounds of fresh produce (8-10 different kinds of produce) plus standard nutrition education. The box will be curated for prenatal nutrients needs and following American Diabetes Association guidelines.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No
Inclusion criteria
* pregnant women receiving care at Harris Health clinics * Medicaid eligible or receiving Medicaid * \<=14 weeks gestation at the time of the first prenatal visit and study enrollment * meet the ACOG criteria for early screening for GDM (have a BMI of 30 or greater and at least one additional ACOG-designated risk factor for GDM from the following: Age \> 35 years; Black, Hispanic, Native American, Asian American or Pacific Islander ethnicity; history of GDM in prior pregnancy; A1c level \> 5.7 & \< 6.4; history of hypertension, pregnancy hypertension, heart disease, HIV, high triglycerides, polycystic ovarian syndrome; Immediate family member (parent or sibling) has had diabetes) * fall within the study delivery radius
Exclusion criteria
* report existing or pregestational T2DM * have hemoglobin A1c\>=7 * are prescribed insulin therapy or metformin upon first screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with gestational diabetes mellitus (GDM) | 24-28 weeks gestational age (about 10-12 weeks after start of the intervention) |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with hypertensive disorders of pregnancy | 24-28 weeks gestational age (about 10 weeks after start of the intervention) |
| Number of infants with macrosomia at birth | at the time of birth |
| Number of infants with pre-term birth | at the time of birth |
| Number of infants born via C-section | at the time of birth |
| Change in Hemoglobin A1c levels | at the time of the first prenatal visit, at the time of birth |
Countries
United States
Contacts
Primary ContactShreela Sharma, PhD
Outcome results
None listed