Fresh RX: NHS 2020
Purpose
This study is an evaluation of the Fresh Rx: Nourishing Healthy Starts program administered by Operation Food Search, a St. Louis-based nonprofit organization. The program provides food and nutrition supports to food insecure pregnant women in conjunction with integrative care services in order to improve health and birth outcomes for both the mother and the child. The purpose of this study is to test the efficacy of this approach through a field experiment, and to assess the extent to which these services can provide cost savings to the healthcare system.
Conditions
- Premature Birth
- Birth Weight
- Post Partum Depression
- Health Care Utilization
- Nutrition Deficiency Due to Insufficient Food
- Housing Problems
- Fetal Complications
- Food Deprivation
Eligibility
- Eligible Ages
- Between 14 Years and 55 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Female - Pregnant - Less than 24 weeks gestation - Screening positive to a USDA two-item food insecurity screener (described below) - Receiving care through a Missouri Medicaid managed care organization - English speaking - Age 14-55 - Missouri resident residing in the following zip codes: 63031, 63033, 63042, 63074, 63114, 63121, 63130, 63132, 63133, 63135, 63136, 63137, 63138, 63140
Exclusion Criteria
- Male - Non-pregnant - Pregnant, but more than 24 weeks gestation - Does not screen positive to a USDA two-item food insecurity screener (described below) - Does not receive care through the Home State Health managed care organization - Non-English speaking - Aged less than 14 or more than 55 - Does not reside in the following zip codes: 63031, 63033, 63042, 63074, 63114, 63121, 63130, 63132, 63133, 63135, 63136, 63137, 63138, 63140
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial Assignment
- Intervention Model Description
- This is a three-arm experiment where each arm iteratively adds additional program components (see study description for more detail).
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Blinding of participants or Operation Food Search staff is infeasible in this study. Operation Food Search will need to know participants' treatment assignment in order to provide the appropriate services, and the participants will also be aware of the services they receive from Operation Food Search. However, the administrative health care claims data used to assess outcomes in this study will not be subject to any bias, as the entities responsible for entering those claims will be blind to the treatment assignment of participants.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Enhanced Usual Care |
The control group in this study will still receive some services above and beyond the usual standard of care offered to pregnant women on Medicaid. In addition to the case management services offered through their managed care provider, Operation Food Search will offer this group access to the "hunger hotline," a service provided by Operation Food Search to help them find food assistance around St. Louis; assistance in enrolling in public nutrition assistance programs like SNAP and WIC; and guidance on food pantry access in St. Louis. |
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|
Experimental Treatment 1: Nutrition Services |
This treatment group will receive all the services offered to the control group, as well as the following services: Weekly food deliveries of fresh food meal kits with step-by-step recipes from the time of program enrollment through 60 days post-partum. Access to necessary cooking tools for their kitchen (e.g., spatulas, cutting boards , etc.), should they need them. Access to online cooking resources to help guide them on culinary skills and recipe preparation. Nutrition education and counseling provided by a registered dietitian. |
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|
Experimental Treatment 2: Integrated Care Services |
This treatment group will receive all the services offered to Treatment Group 1, as well as the services of a Licensed Masters Social Worker who will provide trauma-informed integrative care services to participants. These services will focus on an array of potential needs that may emerge in participants' lives, such as assistance in finding stable housing, assistance navigating social services, connections with other community organizations, and other needs. |
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Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine
Detailed Description
This study is an evaluation of the Fresh Rx: Nourishing Healthy Starts program administered by Operation Food Search, a St. Louis-based nonprofit organization. The goal of the program is to provide food and nutrition supports to food insecure pregnant women in order to improve health and birth outcomes for both the mother and the child. Specifically, this program provides: - Facilitated access to food support programs like the Supplemental Nutrition Assistance Program (SNAP); Women, Infants, and Children (WIC); and food pantries - Direct food delivery to pregnant women, nutrition education, and access to a registered dietitian - Access to a social worker who will provide integrative care services Participants in this program will be recruited through a Medicaid Managed Care Organization (MCO). During their initial intake meeting with an MCO case manager, potential participants will be screened for food insecurity through the use of a two-item food insecurity screener. If a potential participant screens positive for food insecurity, she will be referred to Operation Food Search to begin the Nourishing Healthy Starts recruitment process. Consenting participants will be randomly assigned to one of three conditions (described in detail below), each of which provides the standard of care women would receive in the absence of the program plus additional program features. Control Group. The control group in this study will still receive some services above and beyond the usual standard of care offered to pregnant women on Medicaid. In addition to the case management services offered through their managed care provider, Operation Food Search will offer this group access to the "hunger hotline," a service provided by Operation Food Search to help them find food assistance around St. Louis; assistance in enrolling in public nutrition assistance programs like SNAP and WIC; and guidance on food pantry access in St. Louis. Treatment 1: Food Supplementation and Education Group. This treatment group will receive all the services offered to the control group, as well as the following services: 1. Weekly food deliveries of fresh food meal kits with step-by-step recipes from the time of program enrollment through 60 days post-partum; 2. Access to necessary cooking tools for their kitchen (e.g., spatulas, cutting boards , etc.), should they need them. 3. Access to online cooking resources to help guide them on culinary skills and recipe preparation. 4. Nutrition education and counseling provided by a registered dietitian. Treatment 2: Food Supplementation, Education, and Integrative Case Management. This treatment group will receive all the services offered to Treatment Group 1, as well as the services of a licensed social worker who will provide trauma-informed integrative care services to participants. These services will focus on an array of potential needs that may emerge in participants' lives, such as assistance in finding stable housing, assistance navigating social services, connections with other community organizations, and other needs. This evaluation will combine longitudinal survey data from participants with health claims data provided by the MCOs. Study participants will consent to have their data collected and linked for research purposes. The research team will not have access to any personally identifiable information on program participants, and the team will analyze a deidentified dataset. Each intervention approach will examine a different method of providing women with access to affordable, nutritious food throughout their pregnancy and through the early post-partum period. After it is determined how best to support food insecure women and their families, the evidence from this study may be used to make a case for treating healthy food supports as part of a new standard of care for food insecure pregnant women. The results will provide information to public health agencies, public insurance systems, Medicaid MCOs, and other insurance companies in order to help them understand the potential benefits of these food supports.
