Nurturing Care Family Navigator

NCT ID: NCT06859372

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2027-05-31

Brief 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

Detailed Description

The Nurturing Care Family Navigator (NCFN) is a social behavioral health intervention inspired by the Nurturing Care Framework which provides an evidence-based roadmap across and within five components (i.e., health, nutrition, early learning, security and safety, and responsive caregiving) to transform child rights into equitable actions to address threats and promote optimal early childhood development. We hypothesize that applying a multisectoral nurturing care navigation approach facilitating access to health, nutrition, early learning, responsive care, and security and safety community resources is likely to decrease levels of maternal-child food insecurity.

The NCFN is the navigation program under investigation. 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 assessed using the 8-item Abbreviated Child and Adult Food Security Scale (ACAFSS). The NCFN program is grounded in the Social Cognitive Theory (SCT) aiming to support families in overcoming barriers within and across the four pillars of food security (i.e., food availability, access to food, utilization, and stability). 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.

The target population for the randomized controlled trial will consist of (1) low-income Medicaid or uninsured families with an infant one week postpartum attending the well child visit at a Pediatric clinic through UNLV Health; (2) identified as having very low or low food security in the past 12 months; and (3) residing in one of the zip codes within Clark County, Nevada. The intervention group will receive the NCFN program that will support families through 15 one-on-one sessions over 6 months after enrollment (a total of 15 sessions with 12 sessions in the first 3 months and 3 sessions in the last 3 months) and one year of follow up evaluation with a research assistant. The control group will receive an education workbook package and one year of follow up evaluation with a research assistant. Participants will undergo surveys at enrollment, three, six, and 12 months after enrollment (i.e., baseline, T2, T3, T4). Additionally, the research team will conduct interviews with navigators as well as clinical and non-clinical providers.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control: Non-Navigation Cohort

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental: Navigation Group

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 Type: EXPERIMENTAL

Nurturing Care Family Navigator

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Individuals postpartum low-income, Medicaid publicly funded or uninsured
• Individuals 18 years or older
• Individuals with infants up to two weeks postpartum
• Ability to speak and read English or Spanish
• Established patient at the UNLV Pediatric (at least one well-child visit)
• Lives in one of the zip codes within Clark County, Nevada, United States

Exclusion Criteria

• Intent to transfer care to an institution other than UNLV Pediatric
• Infants who receive at birth any of the following diagnoses: Down syndrome, cleft lip and/or palate, congenital heart disease, neurological conditions, and cardiac problems.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Nevada, Las Vegas

OTHER

Sponsor Role: lead

Responsible Party

Gabriela Buccini

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Nevada Las Vegas

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

U01HD115256

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01OD033239

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UNLV-2024-424

Identifier Type: -

Identifier Source: org_study_id