Nurturing Care Family Navigator

NCT06859372 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-02-03

No results posted yet for this study

Summary

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 services

Researchers 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

Conditions

  • Food Insecurity Among Children
  • Food Insecurity in Post Partum Women
  • Care Coordination in Primary Care
  • Preventive Care / Anticipatory Guidance
  • Retention in Care

Interventions

BEHAVIORAL

Nurturing Care Family Navigator

The Nurturing Care Family Navigator (NCFN) is a comprehensive barrier-focused and long-term family-centered intervention that will offer screenings for food insecurity, referrals to community resources, and follow-up with families experiencing very low or low food security in the past 12 months. The goal of the NCFN is to increase knowledge (cognitive factors) and self-efficacy (behavioral factors) to navigate barriers across the four pillars of food insecurity by securing enrollment and sustaining engagement with a set of community nurturing care services (environmental factors) to improve levels of food security, and ultimately maternal-child health and nutrition outcomes of low-income families during the postpartum phase.

Sponsors & Collaborators

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

    collaborator NIH
  • University of Nevada, Las Vegas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2027-01-30
Completion
2027-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06859372 on ClinicalTrials.gov