72 Participants Needed

Nurturing Care Family Navigator for Food Insecurity

(NCFN Trial)

GB
Overseen ByGabriela Buccini, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Nevada, Las Vegas
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this pilot randomized controlled trial is to determine whether a 6-month behavioral health intervention with a Nurturing Care Family Navigator (NCFN) improves levels of food security among postpartum low-income Medicaid or uninsured women identified as having very low or low food security in the past 12 months. We hypothesize that a behavioral health intervention applying a multisectoral nurturing care navigation approach facilitating access to health, nutrition, early learning, responsive care, and security and safety resources is likely to decrease levels of maternal-child food insecurity. The main question it aims to answer is:* Does the behavioral health intervention with a Nurturing Care Family Navigator (NCFN) improves levels of food security? Outcome 1: Improve levels of food security* Does the behavioral health intervention with a Nurturing Care Family Navigator (NCFN) increase knowledge to navigate barriers across the four pillars of food insecurity? Outcome 2: Increase knowledge across the four pillars of food insecurity* Does the behavioral health intervention with a Nurturing Care Family Navigator (NCFN) increase self-efficacy to secure and sustain enrollment with community nurturing care services? Outcome 3: Increase self-efficacy to secure and sustain enrollment with community nurturing care servicesResearchers will compare levels of food security among those receiving a navigation behavioral health intervention (consisted of 1:1 tailored navigation session and an educational workbook) compared to those receiving an educational workbook with messages across the four pillars of food insecurity (standard of care).Participants will:* Engage in intense weekly navigation 1:1 tailored session for 3 months* Engage in follow up monthly navigation 1:1 tailored session for 3 months* Participate in evaluation calls with a research assistant at enrollment, 3, 6, 12 months

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)
See 2 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental: Navigation GroupExperimental Treatment1 Intervention
Group II: Control: Non-Navigation CohortActive Control1 Intervention

Find a Clinic Near You

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+
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