Fresh RX: NHS 2020

NCT04845230 | Recruiting

• 1 other identifier: 202011018
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

food insecurity; pregnancy; maternal health; neonatal health; birth outcomes; poverty; health care utilization; field experiment; integrative care

Outcome Measures

Primary Outcomes (3)

• Change in food insecurity

  Repeated measures of food insecurity using United States Department of Agriculture (USDA) food insecurity screener

  Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum

• Gestational Age at Birth

  Estimated gestational age (in days) of the child on the delivery date

  Collected at time of birth

• Birthweight

  Weight (in grams) of infant at birth

  Collected at time of birth

Secondary Outcomes (38)

• Change in food spending

  Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum

• Change in self reported physical and mental health

  Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum

• Number of Prenatal Appointments

  Collected quarterly from enrollment through birth

• Maternal Immunizations Received

  Collected quarterly from enrollment through birth

• Change in Maternal Platelet Count

  Collected quarterly from enrollment through birth

Other Outcomes (1)

• Change in cooking skills

  Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum

Study Arms (3)

Enhanced Usual Care

ACTIVE COMPARATOR

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.

Behavioral: FreshRx Nourishing Healthy Starts

Treatment 1: Nutrition Services

EXPERIMENTAL

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.

Behavioral: FreshRx Nourishing Healthy Starts

Treatment 2: Integrated Care Services

EXPERIMENTAL

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.

Behavioral: FreshRx Nourishing Healthy Starts

Interventions

FreshRx Nourishing Healthy Starts BEHAVIORAL

This is a field experiment study that incorporates referrals to public programs, food supplementation and nutrition education, or integrative care services provided by a Licensed Masters Social Worker.

Enhanced Usual Care; Treatment 1: Nutrition Services; Treatment 2: Integrated Care Services

Eligibility Criteria

• Age: 14 Years - 55 Years
• Gender Eligibility Details: This study is an evaluation of a program that provides food and nutrition supports to food insecure pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Operation Food Search Inc.: collaborator

Study Sites (1)

Operation Food Search Inc.

St Louis, Missouri, 63132, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth; Birth Weight; Depression, Postpartum; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Puerperal Disorders; Depressive Disorder; Mood Disorders; Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Stephen Roll, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Roll, PhD

CONTACT

314-935-3710; stephen.roll@wustl.edu

Kourtney Gilbert, MSW

CONTACT

314-935-8142; kgilbert@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a three-arm experiment where each arm iteratively adds additional program components (see study description for more detail).

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 14, 2021
• Study Start: August 9, 2021
• Primary Completion: September 15, 2025
• Study Completion (Estimated): September 15, 2026
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)