Nurturing Care Family Navigator for Food Insecurity

(NCFN Trial)

Overseen By Gabriela Buccini, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Nevada, Las Vegas

Disqualifiers: Down syndrome, Cleft lip, Congenital heart, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special support program, called Nurturing Care Family Navigator, can help new mothers improve their food security. The researchers want to know if a personal guide who connects them to community resources like food and healthcare can make a difference. Participants will receive either this one-on-one support or an educational workbook. The trial seeks new mothers who are on Medicaid or uninsured and have experienced food insecurity in the past year. As an unphased trial, it offers participants the opportunity to access potentially helpful resources and support systems.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a behavioral health intervention to improve food security.

What prior data suggests that the Nurturing Care Family Navigator intervention is safe?

Research shows that the Nurturing Care Family Navigator (NCFN) program is designed for easy participant engagement. Although detailed safety data specific to this program is not available, it primarily offers support and resources rather than medical treatments, suggesting a lower risk of side effects.

The program includes one-on-one sessions to assist families in finding resources, indicating that any risks are minor and relate more to participation logistics than to physical health. Participants in similar programs have not reported major side effects, supporting the idea that the NCFN is a safe choice.

In a trial, safety remains a top priority, and researchers will monitor participants for any issues. Based on current knowledge, the NCFN appears to be a supportive program aimed at enhancing well-being without introducing new health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nurturing Care Family Navigator (NCFN) program because it offers a more personalized approach to tackling food insecurity. Unlike standard methods that provide an educational workbook alone, the NCFN program includes a dedicated navigator who works closely with participants for six months, offering tailored support through 15 sessions. This navigator not only provides intense educational guidance but also connects participants to essential community resources like food, transportation, and housing, especially during the crucial first three months. This hands-on, supportive approach aims to address the broader challenges families face, potentially leading to more sustainable solutions for food insecurity.

What evidence suggests that the Nurturing Care Family Navigator is effective for improving food security?

Research shows that the Nurturing Care Family Navigator (NCFN), available to participants in the experimental arm of this trial, can improve access to food. Past studies have found this approach promising, as it links families to essential resources like food, healthcare, and housing. This method boosts self-confidence, helping individuals feel more assured in obtaining these services. By offering personalized guidance and support, the NCFN assists families in overcoming obstacles to accessing food and other essentials. Overall, evidence suggests that the NCFN effectively addresses food insecurity challenges. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for postpartum low-income Medicaid or uninsured women who have experienced very low or low food security in the past year. It's designed to help them access resources and improve their family's nutrition and overall well-being.

Inclusion Criteria

I can speak and read English or Spanish.

Individuals postpartum low-income, Medicaid publicly funded or uninsured

Established patient at the UNLV Pediatric (at least one well-child visit)

Exclusion Criteria

Intent to transfer care to an institution other than UNLV Pediatric

My newborn has a condition like Down syndrome, cleft lip/palate, heart or neurological issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intense Navigation

Participants engage in intense weekly navigation 1:1 tailored sessions for 3 months

12 weeks

12 visits (in-person)

Follow-up Navigation

Participants engage in follow-up monthly navigation 1:1 tailored sessions for 3 months

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Evaluation calls at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Nurturing Care Family Navigator

Trial Overview The study tests a behavioral health intervention with a Nurturing Care Family Navigator (NCFN) against standard care, which includes an educational workbook. The goal is to see if personalized support improves food security, knowledge about overcoming barriers to nutrition, and confidence in using community services.

How Is the Trial Designed?

Group I: Experimental: Navigation Group Experimental Treatment 1 Intervention

Participants who are randomized into the NCFN program will be assigned to a navigator. The NCFN will deliver the behavioral health navigation intervention consisted an educational workbook (standard of care) plus a total of 15 sessions tailored to the participant needs. The NCFN will offer support and referral to community resources (e.g., food, transportation, housing, healthcare-related). The navigator will provide intense weekly educational support and linkage to resources during the initial three months of the program and additional monthly follow up sessions during the last three months of the program.

Group II: Control: Non-Navigation Cohort Active Control 1 Intervention

Participants in the control group will receive an educational workbook with messages across the four pillars of food insecurity (standard of care). Non-navigation will be provided.

Who Is Running the Clinical Trial?

University of Nevada, Las Vegas

Lead Sponsor

Trials

81

Recruited

14,700+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. trialx.com trialx.com/clinical-trials/listings/300325/nurturing-care-family-navigator/

Nurturing Care Family Navigator Outcome 1: Improve levels of food security; Does the behavioral health intervention with a Nurturing Care Family Navigator (NCFN) increase ...

2. withpower.com withpower.com/trial/nurturing-care-family-navigator-for-food-insecurity-a5f21

Nurturing Care Family Navigator for Food Insecurity Outcome 3: Increase self-efficacy to secure and sustain enrollment with community nurturing care servicesResearchers will compare levels of food security ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11157999/

Nurturing care assets for food security - PubMed Central - NIH FI increases the risk of adverse outcomes during pregnancy such as maternal depression and anxiety, malnutrition, and anemia [11], as well as ...

4. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-025-24714-9

a mixed-methods RE-AIM evaluation | BMC Public Health This study aimed to (1) document the participatory co-creation of a Community Workshop Series with topics across the Nurturing Care Framework ...

5. mdpi.com mdpi.com/2072-6643/17/15/2427

Impacts of Food Insecurity on Child Development In 2023, the USDA reported that 17.9% of U.S. households with children were food insecure, meaning they had limited or uncertain access to adequate food.

6. trial.medpath.com trial.medpath.com/clinical-trial/ec3c32bfae1e646a/nct06859372-family-navigator-maternal-child-food-insecurity

Nurturing Care Family Navigator | MedPath Number of NCFN sessions completed (range 0-12). Engage in a total of 12 one-on-one session over three-months. Navigation interruptions/stoppages were considered ...

7. first5nevada.org first5nevada.org/news-and-articles/nurturing-care-family-navigator-study/

Nurturing Care Family Navigator Study This study has a strong potential to contribute to improving the health and well-being of mothers/caregivers and their babies. Parenting and Family Support ...

8. nurturing-care.org nurturing-care.org/

Nurturing Care Framework for Early Childhood Development A framework and a roadmap for action that draws on state-of-the-art evidence to help children SURVIVE and THRIVE to TRANSFORM health and human potential.