Fresh RX: NHS 2020

ConditionsPremature Birth Birth Weight Post Partum Depression Health Care Utilization Nutrition Deficiency Due to Insufficient Food Housing Problems Fetal Complications Food Deprivation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age14-55

SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Female

Pregnant

Less than 24 weeks gestation

Screening positive to a USDA two-item food insecurity screener (described below)

Disqualifiers

Male

Non-pregnant

Pregnant, but more than 24 weeks gestation

Does not screen positive to a USDA two-item food insecurity screener (described below)

Trial design

Design model

Factorial

Treatments tested in this trial

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.

Treatment groups

750 Participants

are divided into 3 treatment groups

Group A: Enhanced Usual CareActive comparator 1 intervention

Group B: Treatment 1: Nutrition ServicesExperimental treatment 1 intervention

Group C: Treatment 2: Integrated Care ServicesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in food insecurity

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

Time frame

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

Time frame

Collected at time of birth

Birthweight

Weight (in grams) of infant at birth

Time frame

Collected at time of birth

Secondary outcomes

Change in food spending

A continuous measure asking about weekly expenditures on groceries and eating and restaurants, and other food options

Time frame

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

Change in self reported physical and mental health

Measures captured using an abbreviated 5-item Patient Reported Outcomes Measurement Information System (PROMIS) screener

Time frame

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

Number of Prenatal Appointments

Number of prenatal health appointments received during pregnancy

Time frame

Collected quarterly from enrollment through birth

Maternal Immunizations Received

Pregnancy-related immunizations received (e.g., Tdap, influenza) during pregnancy

Time frame

Collected quarterly from enrollment through birth

Other outcomes

Change in cooking skills

Incidence of using basic and advanced kitchen tasks. Participants will be asked how often they perform an array of given tasks (Never, Rarely, Monthly, Weekly, Daily) such as boiling water, following a recipe, using a chef's knife, and so on, through a matrix question listing these tasks.

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

Operation Food Search Inc.

Collaborator

Source ClinicalTrials.gov

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