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Food Insecurity Among ChildrenNCFNNCT06859372

Nurturing Care Family Navigator

A study testing Nurturing Care Family Navigator in people with Food Insecurity Among Children and Food Insecurity in Post Partum Women, run by University of Nevada, Las Vegas at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Nurturing Care Family Navigator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteUnited States
Study dates
10 Mar 2025to 31 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Nevada Las Vegas

    Las Vegas, Nevada, 89199

Other trials in United States

About this study

Official title: Nurturing Care Family Navigator: Establishing Practices for Navigating Maternal-Child Food Insecurity

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
Read more

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
Read the 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.

Being tested
Nurturing Care Family Navigator
Keywords
Maternal-Child Health, Food Insecurity, Navigation, Postpartum, Pediatrics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nurturing Care Family NavigatorBehavioural

    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.

Study groups in NCT06859372
Study groupRoleWhat they receive
Control: Non-Navigation CohortNo interventionParticipants 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 GroupExperimentalParticipants 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.
Receives: Behavioral: Nurturing Care Family Navigator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: T2 (3 months)

  2. 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.

    Measured: T3 (6 months)

  3. 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.

    Measured: T3 (6 months)

  4. 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.

    Measured: Baseline

  5. 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).

    Measured: Baseline and T2 (3 months)

  6. 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)

    Measured: Baseline and T3 (6 months)

  7. 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)

    Measured: Baseline and T4 (12 months)

Secondary outcomes (6)
  1. Patient reported Perceived Barriers to Food Security

    The Barriers Needs Assessment Form is a non-validated questionnaire created by the research team to assess perceived barriers to food security such as personal, food, transportation, healthcare, infant, housing, and resource concerns. By systematically identifying perceived barriers, the intervention can implement targeted strategies to address them, such as connecting participants with community resources.The questionnaire was designed with yes/no questions and range from 0 to 52 perceived barriers. Higher scores represent greater perceived barriers. The questionnaire will assess perceived barriers in the intervention and control groups at each time point: baseline T2 (3 months), T3 (6 months), and T4 (12 months).The assessment of perceived barriers will be used to document changes across different time points.

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

  2. Patient-reported Self-Efficacy for Food Security Scale

    The Self-Efficacy for Food Security Scale is a validated questionnaire designed to assess an individual's confidence in their ability to access and maintain a sufficient and nutritious food supply despite potential challenges. Responses range from 1-4 and they are recorded on a Likert scale ranging from "not at all confident" to "very confident", allowing for an assessment of self-efficacy levels. Higher scares indicate greater self-efficacy: 3-4 indicates high self-efficacy and 1-3 indicates low self-efficacy. The questionnaire will assess both the intervention and control groups at each time point: baseline T2 (3 months), T3 (6 months), and T4 (12 months).The assessment of self-efficacy will be used to document changes across different time points.

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

  3. Patient-reported Perceived Agency ("Seeking" Behavior)

    Differences in "seeking" behavior assessed by the agency questionnarie at baseline, T2 (3 months), T3 (6 months), T4 (12 months).The perceived agency questionnaire was adapted by the research team. It consists of five questions, and each question is scored on a 3-point scale between 1 and 3. Total scores ranges from 5 to 15. Higher scores indicate greater agency/seeking behavior.

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

  4. Patient-reported Maternal Diet Quality Index

    Maternal diet quality reported through the validated Rapid Prime Diet Quality Score Screener (rPDQS).The RPDQS Screener is a brief dietary assessment tool designed to quickly evaluate diet quality based on key food groups associated with health outcomes. It consists of a short questionnaire of 13 questions assessing the consumption of beneficial and harmful food groups and one evaluation of alcohol consumption. The scoring system is a numeric scoring approach that allocates 0 to 4 points to consumption of each of the six food groups whose intake is encouraged (with a reverse scoring for the seven food groups to limit) based on the original frequency of consumption (range, 0-52; higher = healthier).

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

  5. Patient-reported Breastfeeding Status

    Total duration of exclusive or partial breastfeeding at enrollment, 3 months, 6 months, and 12 months

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

  6. Patient-reported Infant Feeding

    Infant feeding quality assessed through the World Health Organization Infant. This questionnaire allows to assess a set of indicators to assess infant and young child feeding.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2025
  2. Study start10 Mar 2025
  3. Primary completion30 Jan 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06859372
Sponsor's protocol ID
UNLV-2024-424
Other IDs
U01HD115256, U01OD033239
Acronym
NCFN
Status last verified
Jan 2026
First submitted
16 Jan 2025
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected IPD and all IPD that underlie results will be made available in publications.

Questions about this trial

What is this clinical trial studying?

A study testing Nurturing Care Family Navigator in people with Food Insecurity Among Children and Food Insecurity in Post Partum Women, run by University of Nevada, Las Vegas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intense Navigation Completion (time frame: T2 (3 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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