Produce Rx in High-Risk Pregnant Mothers at Harris Health.
Project Overview
The purpose of our study is to assess if a Harris Health System comprehensive Produce Prescription Program (FoodRx), providing consistent access to healthy food plus nutrition education, impacts gestational weight gain, and other health outcomes in low-income, ethnically diverse, at-risk women in Harris County.
Project Details
The purpose of the study is to assess if a Harris Health System comprehensive Produce Prescription Program (FoodRx) that provides consistent access to healthy food 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 in Harris County. This proposed study will be conducted over a 24-month period starting September 2023. Recruitment will begin in pregnancy during first prenatal visit to a Harris Health System (HHS) high-risk obstetric clinic. Each woman will be followed until 60 days post-partum (11-month duration). We will conduct an analysis of survey and clinical data collected by UTSPH and HHS.
Details
The purpose of the study is to assess if a Harris Health System comprehensive Produce Prescription Program (FoodRx) that provides consistent access to healthy food 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 in Harris County. This proposed study will be conducted over a 24-month period starting September 2023. Recruitment will begin in pregnancy during first prenatal visit to a Harris Health System (HHS) high-risk obstetric clinic. Each woman will be followed until 60 days post-partum (11-month duration). We will conduct an analysis of survey and clinical data collected by UTSPH and HHS.
Project Protocol
This proposed study, which will be conducted over a 2-year period starting September 2023, is a collaboration among Harris Health System, Planet Harvest, Brighter Bites, and UTHealth Houston.
The purpose of our study is to assess selected health impacts of a Produce Prescription Program (PPRx) that provides consistent access to healthy food plus nutrition education to a sample of low-income, ethnically diverse, at-risk women residing in Harris County, Texas.
Outcomes of interest include gestational weight gain along with other pregnancy and birth outcomes, and food and nutrition security. HHS will enroll eligible participants. Planet Harvest and Brighter Bites will provide the food deliveries and accompanying nutritional and cooking information. UTHealth will conduct the evaluation of the study.
Primary Objective
The primary objective of this project is to assess the feasibility and preliminary effects of differing doses of a home delivery produce prescription program on a wide range of clinical and non-clinical outcomes among low-income, ethnically diverse pregnant mothers.
Secondary Objective
The project’s secondary objective includes the evaluation of firm level outcomes related to program implementation.
The Center for Health Equity is conducting an evaluation of the program using survey and clinical data collected by UTSPH and HHS.
Study Design
Ethical considerations do not allow for a no-dose control arm; therefore, the proposed study is an experimental study with an active control group. Enrolled women will be randomly assigned 1:1 to one of two groups (Prescription Dose group vs Maintenance Dose group), after stratifying by gestational age at the time of enrollment. Stratification by gestational age is necessary to allow for comparable follow-up time across participants, as well as to schedule measurements.
The two groups are:
Group 1: Monthly home deliveries of 20 lbs (~50 servings) of fresh produce (8-10 different kinds of produce) delivered towards the second half of the month plus nutrition education. (Maintenance Dose)?
Group 2: Biweekly deliveries of 20 lbs (~50 servings) of fresh produce (8-10 different kinds of produce) plus nutrition education.? (Prescription Dose)?
The differing dosages of exposure to fruits and vegetables may allow us to assess dose-sufficiency as well as dose-response effects. Other studies have shown improvements in clinical outcomes with biweekly produce boxes, but few studies have examined if monthly supplementation of produce boxes are sufficient to improve outcomes. Additionally, we are timing for Group 1 monthly deliveries to be in the second half of the month given that financial needs are usually higher towards the second half of the month than the first. These data on effectiveness across differing dosages of produce delivery will also provide important data for future sustainability and scalability.?
Within group estimates of changes in key outcomes will be obtained for outcomes with pre-intervention values. In the case of incident outcomes, such as weight gain, gestational diabetes, and low birth weight, within group incidence will be compared with published estimates in normative populations. In all cases, between group assessments of change in outcomes will be estimated. Estimates will be obtained via covariate-adjusted regression models.
Study Population
HHS will screen pregnant women at their high-risk obstetric clinics at the time of the first prenatal visit. As the healthcare provider, HHS will be able to identify women who meet the inclusion criteria for the program of i) receiving prenatal care at high-risk obstetric clinics; ii) 18 and 44 years of age; iii) <= 20 weeks medically-confirmed viable pregnancy; iv) designated as high risk (Age>=35 years, or obese or overweight (BMI>=25.0 at pre-pregnancy self-report), or prior history of pregnancy hypertension or gestational diabetes), and v) within the zip code delivery radius.
Project Contact: Naomi Tice, MPH
Project Team
Principal Investigator
Shreela Sharma, PhD, RDN, LD
Director, Center for Health Equity
Professor and Vice Chair, Department of Epidemiology
Project Manager
Naomi Tice, MPH
Center for Health Equity
Research Coordinator III
Wesley Gibson
Center for Health Equity
Research Scientist
Maha Almohamad, MS
Center for Health Equity
