Clinical trial NCT06275568: Accelerating Healthcare Engagement in Healthy Food Interventions - Food Rx in High Risk Pregnant Mothers With About Fresh and Texas Children's Health Plan
Official title: Accelerating Healthcare Engagement in Healthy Food Interventions - Food Rx in High Risk Pregnant Mothers With About Fresh and Texas Children's Health Plan
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nutrition in High-Risk Pregnancy
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 620
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: Inclusion Criteria:

* high-risk pregnant mothers receiving care at Texas Children's Health Plan (TCHP) managed care organizations in Houston, Texas
* \<20 weeks medically confirmed viable pregnancy
* 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:

* not a high-risk pregnant mother receiving care at Texas Children's Health Plan (TCHP) managed care organizations in Houston, Texas

Primary outcomes:
measure: Absolute gestational weight gain (GWG) in pounds
timeFrame: From the start of the first trimester of pregnancy to the end of the first trimester of pregnancy (3 months)
measure: Absolute gestational weight gain (GWG) in pounds
timeFrame: From the start of the second trimester of pregnancy to the end of the second trimester of pregnancy (3 months)
measure: Absolute gestational weight gain (GWG) in pounds
timeFrame: From the start of the third trimester of pregnancy to the end of the third trimester of pregnancy (3 months)
measure: Excess gestational weight gain (EGWG) in pounds
timeFrame: From the start of the first trimester of pregnancy to the end of the first trimester of pregnancy (3 months)
measure: Excess gestational weight gain (EGWG) in pounds
timeFrame: From the start of the second trimester of pregnancy to the end of the second trimester of pregnancy (3 months)
measure: Excess gestational weight gain (EGWG) in pounds
timeFrame: From the start of the third trimester of pregnancy to the end of the third trimester of pregnancy (3 months)
Secondary outcomes:
measure: Number of participants diagnosed with pregnancy-induced hypertension
timeFrame: From the time of enrollment until the time of birth (up to 9 months)
measure: Number of participants diagnosed with gestational diabetes
timeFrame: From the time of enrollment until the time of birth (up to 9 months)
measure: Number of participants with pre-term birth (<37 weeks)
timeFrame: at the time of birth
measure: Infant birth weight
timeFrame: at the time of birth
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Shreela Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
References: