Nurturing Care Family Navigator

NCT06859372 | Active Not Recruiting

• 3 other identifiers: UNLV-2024-424U01HD115256U01OD033239
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Maternal-Child Health; Food Insecurity; Navigation; Postpartum; Pediatrics

Outcome Measures

Primary Outcomes (7)

• Intense Navigation Completion

  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 incomplete intervention. A 90% navigation completion rate was chosen a priori to indicate a promising intervention.

  T2 (3 months)

• Follow Up Navigation Completion

  Engage in a total of 3 follow up session over three-months after the end of the intense intervention (range 0-3). Number of follow-up sessions completed. A 90% navigation completion rate was chosen a priori to indicate a promising intervention.

  T3 (6 months)

• Navigation Completion

  Engage in a total of 15 one-on-one session over six-months. Navigation interruptions/stoppages were considered incomplete intervention. A 90% navigation completion rate was chosen a priori to indicate a promising intervention.

  T3 (6 months)

• Food Security Status Baseline

  Food security status will be determined by the sum of affirmative responses to the 8-item Abbreviated Child and Adult Food Security Scale (ACAFSS) in the past 12 months. ACAFSS scores range from 0 to 8. Higher scores represent greater food insecurity: 0-1 means the household is food secure; 2-4 means the household is low food security; 5-8 means the household is very low food security.

  Baseline

• Food Security Status Point 1

  Food security status will be determined by the sum of affirmative responses to the 8-item Abbreviated Child and Adult Food Security Scale (ACAFSS) in the past 30 days. ACAFSS scores range from 0 to 8. Higher scores represent greater food insecurity: 0-1 means the household is food secure; 2-4 means the household is low food security; 5-8 means the household is very low food security. Changes in scores and food security status will be examined between Baseline and T2 (3 months).

  Baseline and T2 (3 months)

• Food Security Status Point 2

  The unabbreviated scale used to measure the participants' food security status is the Abbreviated Child and Adult Food Security Scale (ACAFSS), validated for 12 months and 30 days in the United States population. ACAFSS scores range from 0 to 8. Higher scores represent greater food insecurity: 0-1 means the household is food secure; 2-4 means the household is low food security; 5-8 means the household is very low food security. Changes in scores and food security status will be examined between Baseline and T3 (6 months)

  Baseline and T3 (6 months)

• Food Security Status Point 3

  The unabbreviated scale used to measure the participants' food security status is the Abbreviated Child and Adult Food Security Scale (ACAFSS), validated for 12 months and 30 days in the United States population. ACAFSS scores range from 0 to 8. Higher scores represent greater food insecurity: 0-1 means the household is food secure; 2-4 means the household is low food security; 5-8 means the household is very low food security.Changes in scores and food security status will be examined between Baseline and T4 (12 months)

  Baseline and T4 (12 months)

Secondary Outcomes (6)

• Patient reported Perceived Barriers to Food Security

  Baseline, T2 (3 months), T3 (6 months), T4 (12 months)

• Patient-reported Self-Efficacy for Food Security Scale

  Baseline, T2 (3 months), T3 (6 months), T4 (12 months)

• Patient-reported Perceived Agency ("Seeking" Behavior)

  Baseline, T2 (3 months), T3 (6 months), T4 (12 months)

• Patient-reported Maternal Diet Quality Index

  Baseline, T2 (3 months), T3 (6 months), T4 (12 months)

• Patient-reported Breastfeeding Status

  Baseline, T2 (3 months), T3 (6 months), T4 (12 months)

Other Outcomes (11)

• Patient-reported Postpartum Depression Screening using Edinburgh Postnatal Depression Scale (EPDS)

  Baseline, T2 (3 months)

• Patient-reported Postpartum Depression Symptoms using the Patient Health Questionnaire (PQH-9)

  Baseline, T2 (3 months), T3 (6 months), T4 (12 months)

• Patient-reported Anxiety Symptoms using the General Anxiety Disorder-7 (GAD-7)

  Baseline, T2 (3 months), T3 (6 months), T4 (12 months)

Study Arms (2)

Control: Non-Navigation Cohort

NO 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.

Experimental: Navigation Group

EXPERIMENTAL

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.

Behavioral: Nurturing Care Family Navigator

Interventions

Nurturing Care Family Navigator 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.

Experimental: Navigation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Nevada Las Vegas

Las Vegas, Nevada, 89199, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: March 5, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)