Food InsecurityNCT07101757
Neonatal Neurodevelopmental Outcomes
An observational study of Food Insecurity and Depression, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The main goal of this research is to help mothers with depression and anxiety to cope and bond with their baby. The next goal is to provide resources to help with household needs like food, rent, or utility assistance, health insurance. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity, Depression, Anxiety
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2025to 1 Sep 2027
- Phase
- Observational
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study will include adult caregivers (18 years or older) who speak English or Spanish and have infants aged 0-6 months hospitalized at Texas Children's Hospital. Caregivers must be willing to participate in study activities. Those without primary custody, living outside Texas, or previously enrolled in the study will not be eligible
Who may be able to join
- Caregivers of young infants (0-6 months of age) hospitalized at Texas Children's Hospital intensive care or acute care units.
- English or Spanish speaking caregiver.
- Age of caregiver ≥ 18 years old.
- Caregiver willing to complete study procedures.
Who cannot join
- Caregivers who do not have primary custody.
- Caregivers who live outside of Texas (due to lack of Houston Food Bank resources outside of Texas).
- Children in CPS custody.
- Caregiver is not the primary caregiver.
- Previous enrollment in this study.
- Neonates who are non-viable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neonatal Neurodevelopmental Outcomes: Addressing Family Needs and Strengthening the Caregiver-Baby Bond
The main goal of this research is to help mothers with depression and anxiety to cope and bond with their baby.
The next goal is to provide resources to help with household needs like food, rent, or utility assistance, health insurance. Our theory is that helping with food insecurity, household needs, and emotional health will help children and families.
Read the detailed description
The purpose of this study is to support families of children who are hospitalized. Participants will be asked to complete a survey regarding resources that may enhance caregiver wellbeing. These resources are intended to also support the health and developmental potential of the hospitalized child.
There is a small risk of loss of confidentiality associated with participation in the research; however, the investigators have implemented multiple safeguards to protect participant information. There is no guarantee of direct benefit from participation. If a need for resources is identified, participants may be referred to hospital-based food resources or a local food bank, which could be beneficial.
Additionally, many mothers of hospitalized children experience symptoms of depression, anxiety, and stress. A program is available within the hospital that includes access to a specialist and supportive resources for those experiencing such feelings.
The findings from this study may inform future efforts to assist caregivers more effectively. Participation in this research is voluntary, and individuals may instead request a social work consultation to determine eligibility for available resources without enrolling in the study.
- Conditions
- Food Insecurity, Depression, Anxiety, Stress
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Positive Screens | * Enrollment survey * Referral to behavior health clinician (BHC) * Referral to emergency psychiatric services * Referral the Houston Food Bank (HFB) * Follow-up surveys | |
| Negative Screens | -Enrollment survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Implementation
Assessed by the proportion of eligible participants who enroll and complete the intervention protocol.
Unit of Measure: Percentage of participants completing the intervention.
Measured: 12 months
Acceptability of Intervention
Measured using the Acceptability of Intervention Measure (AIM), a validated 4-item Likert scale assessing participant perceptions of the intervention.
Unit of Measure: Mean AIM score (range: 1-5).
Measured: 12 months
Caregiver Mental Health Outcomes
Evaluated using the Patient Health Questionnaire-9 (PHQ-9) for depression and the Generalized Anxiety Disorder-7 (GAD-7) scale for anxiety.
Unit of Measure: Mean scores on PHQ-9 and GAD-7.
Measured: 12 months
Caregiver-Infant Bonding and Nurture
Assessed using the Postpartum Bonding Questionnaire (PBQ) to evaluate caregiver-infant bonding.
Unit of Measure: Mean PBQ score.
Measured: 12 months
Addressing Non-Medical Drivers of Health
Measured by the number of referrals made to food, housing, or mental health resources and the proportion of participants who accessed at least one referred service.
Unit of Measure: Count of referrals and percentage of participants accessing services.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start8 Sep 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Episcopal Health Foundation
- Responsible party
- Principal investigator, Michelle Lopez, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101757
- Sponsor's protocol ID
- H-57296
- Status last verified
- Sep 2026
- First submitted
- 18 Jul 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Neurodevelopmental Outcomes: Addressing Family Needs and Strengthening the Caregiver-Baby Bond
- ClinicalTrials.gov ID
- NCT07101757
- Acronym / sponsor ID
- H-57296
- Conditions
- Food Insecurity, Depression, Anxiety, Stress
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Episcopal Health Foundation
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of this research is to help mothers with depression and anxiety to cope and bond with their baby.
The next goal is to provide resources to help with household needs like food, rent, or utility assistance, health insurance. Our theory is that helping with food insecurity, household needs, and emotional health will help children and families.
Detailed description
The purpose of this study is to support families of children who are hospitalized. Participants will be asked to complete a survey regarding resources that may enhance caregiver wellbeing. These resources are intended to also support the health and developmental potential of the hospitalized child.
There is a small risk of loss of confidentiality associated with participation in the research; however, the investigators have implemented multiple safeguards to protect participant information. There is no guarantee of direct benefit from participation. If a need for resources is identified, participants may be referred to hospital-based food resources or a local food bank, which could be beneficial.
Additionally, many mothers of hospitalized children experience symptoms of depression, anxiety, and stress. A program is available within the hospital that includes access to a specialist and supportive resources for those experiencing such feelings.
The findings from this study may inform future efforts to assist caregivers more effectively. Participation in this research is voluntary, and individuals may instead request a social work consultation to determine eligibility for available resources without enrolling in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Screens | – | –* Enrollment survey * Referral to behavior health clinician (BHC) * Referral to emergency psychiatric services * Referral the Houston Food Bank (HFB) * Follow-up surveys |
| Negative Screens | – | –-Enrollment survey |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will include adult caregivers (18 years or older) who speak English or Spanish and have infants aged 0-6 months hospitalized at Texas Children's Hospital. Caregivers must be willing to participate in study activities. Those without primary custody, living outside Texas, or previously enrolled in the study will not be eligible
Key inclusion criteria (4 listed)
- Caregivers of young infants (0-6 months of age) hospitalized at Texas Children's Hospital intensive care or acute care units.
- English or Spanish speaking caregiver.
- Age of caregiver ≥ 18 years old.
- Caregiver willing to complete study procedures.
Key exclusion criteria (6 listed)
- Caregivers who do not have primary custody.
- Caregivers who live outside of Texas (due to lack of Houston Food Bank resources outside of Texas).
- Children in CPS custody.
- Caregiver is not the primary caregiver.
- Previous enrollment in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of Intervention Implementation
Time frame: 12 months
Assessed by the proportion of eligible participants who enroll and complete the intervention protocol. Unit of Measure: Percentage of participants completing the intervention.
Acceptability of Intervention
Time frame: 12 months
Measured using the Acceptability of Intervention Measure (AIM), a validated 4-item Likert scale assessing participant perceptions of the intervention. Unit of Measure: Mean AIM score (range: 1-5).
Caregiver Mental Health Outcomes
Time frame: 12 months
Evaluated using the Patient Health Questionnaire-9 (PHQ-9) for depression and the Generalized Anxiety Disorder-7 (GAD-7) scale for anxiety. Unit of Measure: Mean scores on PHQ-9 and GAD-7.
Caregiver-Infant Bonding and Nurture
Time frame: 12 months
Assessed using the Postpartum Bonding Questionnaire (PBQ) to evaluate caregiver-infant bonding. Unit of Measure: Mean PBQ score.
Addressing Non-Medical Drivers of Health
Time frame: 12 months
Measured by the number of referrals made to food, housing, or mental health resources and the proportion of participants who accessed at least one referred service. Unit of Measure: Count of referrals and percentage of participants accessing services.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No. IPD data will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Insecurity and Depression, run by Baylor College of Medicine 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 4 inclusion and 6 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 30 Sep 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?
Feasibility of Intervention Implementation (time frame: 12 months). The study lists 5 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 30 Sep 2026.