Clinical trial NCT06859372: Nurturing Care Family Navigator
Official title: Nurturing Care Family Navigator: Establishing Practices for Navigating Maternal-Child Food Insecurity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Food Insecurity Among Children
Food Insecurity in Post Partum Women
Care Coordination in Primary Care
Preventive Care / Anticipatory Guidance
Retention in Care
Keywords: Maternal-Child Health
Food Insecurity
Navigation
Postpartum
Pediatrics
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2025-03-05
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 within one of our focus zip codes (89101, 89106, 89030, 89031, 89032). 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.

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 target zip codes in Nevada, United States (89106, 89101, 89030, 89031, and 89032)

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.

Primary outcomes:
measure: Intense Navigation Completion
timeFrame: T2 (3 months)
measure: Follow Up Navigation Completion
timeFrame: T3 (6 months)
measure: Navigation Completion
timeFrame: T3 (6 months)
measure: Food Security Status Baseline
timeFrame: Baseline
measure: Food Security Status Point 1
timeFrame: Baseline and T2 (3 months)
measure: Food Security Status Point 2
timeFrame: Baseline and T3 (6 months)
measure: Food Security Status Point 3
timeFrame: Baseline and T4 (12 months)
Secondary outcomes:
measure: Patient reported Perceived Barriers to Food Security
timeFrame: Baseline, T2 (3 months), T3 (6 months), T4 (12 months)
measure: Patient-reported Self-Efficacy for Food Security Scale
timeFrame: Baseline, T2 (3 months), T3 (6 months), T4 (12 months)
measure: Patient-reported Perceived Agency ("Seeking" Behavior)
timeFrame: Baseline, T2 (3 months), T3 (6 months), T4 (12 months)
measure: Patient-reported Maternal Diet Quality Index
timeFrame: Baseline, T2 (3 months), T3 (6 months), T4 (12 months)
measure: Patient-reported Breastfeeding Status
timeFrame: Baseline, T2 (3 months), T3 (6 months), T4 (12 months)
measure: Patient-reported Infant Feeding
timeFrame: Baseline, T2 (3 months), T3 (6 months), T4 (12 months)
Other outcomes:
measure: Patient-reported Postpartum Depression Screening using Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Baseline, T2 (3 months)
measure: Patient-reported Postpartum Depression Symptoms using the Patient Health Questionnaire (PQH-9)
timeFrame: Baseline, T2 (3 months), T3 (6 months), T4 (12 months)
measure: Patient-reported Anxiety Symptoms using the General Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline, T2 (3 months), T3 (6 months), T4 (12 months)
measure: Patient-reported Stress using the Postpartum Stressors Scale (PPSS)
timeFrame: Baseline
measure: Patient-reported Perceived Discrimination using the Perceived Personal Discrimination in Interactions with Healthcare Providers
timeFrame: Baseline, T2 (3 months), T3 (6 months), T4 (12 months)
measure: Patient-reported Social Support using Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Baseline, T2 (3 months), T3 (6 months), T4 (12 months)
measure: Patient-reported Perceived Nutrition Environment
timeFrame: Baseline, T2 (3 months), T3 (6 months), T4 (12 months)
measure: Patient-reported Satisfaction with Navigator Interpersonal Relationship (PSN-I)
timeFrame: T2 (3 months)
measure: Program data - Number of referrals
timeFrame: T2 (3 months), T3 (6 months), T4 (12 months)
measure: Program data - Participation in community workshops
timeFrame: T2 (3 months), T3 (6 months), T4 (12 months)
measure: Program data - Number of Resources Enrolled
timeFrame: Baseline, T2 (3 months), T3 (6 months), T4 (12 months)
Locations:
city: Las Vegas
country: United States
facility: University of Nevada Las Vegas
state: Nevada
Study officials:
References: