Nutrition in High-Risk Pregnancy
Conditions
Brief summary
The purpose of the study is to assess if the Fresh Connect food prescription (Fresh Connect Food Rx) program that provides consistent access to healthy fresh produce through purchases at the grocery store plus nutrition education impacts gestational weight gain, other pregnancy and birth outcomes, and food and nutrition security in low-income, ethnically diverse, at-risk women residing in Houston, Texas. Enrollment of participants will begin in pregnancy at the time of the first prenatal visit (as long as the first visit occurs before the end of the first trimester); each participant will be followed until 60 days post-partum (up to 11 months follow-up per participant).
Interventions
BEHAVIORALUsual Care Fresh Connect cardholder engagement
Fresh Connect, a Food as Medicine product of the non-profit organization About Fresh, Inc., consists of a pre paid, programmable debit card, a cloud-based cardholder success platform, and an analytic engine designed to illuminate the healthcare value of improved food access and nutritional security. This arm receives: * About Fresh Food Rx debit card ($100 per month from enrollment until 2 months post-partum) * Texts for all cardholders per month (1-2 outbound texts) * Welcome call from About Fresh cardholder engagement team * 1 text - notification that Fresh Connect funds have been reloaded * As-needed program updates (e.g. new retailers), inactivity outreach * Additional texts that would be ad hocs: texts with food experiences (cooking videos), produce how-tos, and fun engagement; and satisfaction surveys - e.g. feedback on the Fresh Connect program, feedback on retailers, satisfaction with cardholder success, etc.
BEHAVIORALEnhanced engagement communication
Enhanced engagement involves additional outbound texts per month and additional ad hoc bi-monthly or quarterly texts, as well as tailored reminder text to use funds before the end of the month.
Sponsors
The University of Texas Health Science Center, Houston
American Heart Association
Tufts University
Michael and Susan Dell Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Less than or equal to 20 weeks medically confirmed viable pregnancy * high-risk pregnant mothers receiving care at Community Health Choice managed care organizations in Houston, Texas (High risk may include overweight/obese pre-pregnancy or at first trimester (self-report or measured BMI\>30.0), and/or prior history of diabetes or gestational diabetes, and/or prior history of hypertension or pregnancy-induced hypertension)
Exclusion criteria
* Does not Speak English or Spanish
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute gestational weight gain (GWG) in pounds | From the start of the first trimester of pregnancy to the end of the first trimester of pregnancy (3 months) |
| Excess gestational weight gain (EGWG) in pounds | From the start of the first trimester of pregnancy to the end of the first trimester of pregnancy (3 months) |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants diagnosed with pregnancy-induced hypertension | From the time of enrollment until the time of birth (up to 9 months) |
| Number of participants diagnosed with gestational diabetes | From the time of enrollment until the time of birth (up to 9 months) |
| Number of participants with pre-term birth (<37 weeks) | at the time of birth |
| Infant birth weight | at the time of birth |
Countries
United States
Contacts
CONTACTShreela Sharma, PhD
CONTACTNaomi Tice, MPH
PRINCIPAL_INVESTIGATORShreela Sharma, PhD
The University of Texas Health Science Center, Houston
Outcome results
None listed