Pregnancy RelatedNCT05341960
Nourishing Beginnings: Addressing Food Insecurity During Pregnancy
A study testing Food Delivery and Financial Support in people with Pregnancy Related and Food Insecurity, run by Case Western Reserve University at 2 sites in United States.
Trial summary
This is a pilot project designed to test the feasibility of implementing a community health worker (CHW)-led intervention to improve nutritious food access and consumption among pregnant people and to evaluate the effectiveness of this approach. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Food Insecurity, Premature Birth
- What is being tested?
- Food Delivery and Financial Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2022to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medicaid eligible
- Enrolls in the CHW Hub
- Able to read and understand English
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mom's First
Cleveland, Ohio, 44106
Better Health Partnership CHW HUB
Cleveland, Ohio, 44113
About this study
Official title: Nourishing Beginnings: Addressing Food Insecurity Among Medicaid-Eligible Pregnant Individuals
This is a pilot project designed to test the feasibility of implementing a community health worker (CHW)-led intervention to improve nutritious food access and consumption among pregnant people and to evaluate the effectiveness of this approach. The project will be conducted in partnership with the Greater Cleveland Food Bank and the Better Health Partnership Community Health Worker HUB
Read the detailed description
The Nourishing Beginnings pilot study will enroll 160 pregnant individuals (<22 weeks gestation) who are eligible to use the Partnership Community HUB (i.e., Medicaid eligible). Participants will be randomly assigned into one of two intervention arms - either direct food delivery (n=80) or small financial resources and individualized navigation support for accessing local healthy foods (n=80).
The pilot will (1) assess the feasibility and allow protocol refinement; (2) assess the preliminary impact of CHW-led intervention; and (3) conduct a rigorous process evaluation of the implementation of the intervention using an effectiveness-implementation hybrid type 1 design. Dietary behavior, psychosocial health, health care utilization, and health outcomes and birth outcomes will be tracked at baseline, mid-pregnancy, and at delivery, derived from both primary and secondary data sources (i.e., Hub and claims data). Critical implementation points (referral, CHW touch points, and food delivery) will be assessed. Intervention arms will be compared to a matched comparison group derived from local claims data for the same time period.
- Being tested
- Food Delivery, Financial Support
- Keywords
- Food Insecurity, Community Health Workers, Food Delivery, Prenatal Nutrition, Social Determinants of Health
- Medical subject headings
- Premature Birth, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food DeliveryBehavioural
Food box with food to feed a family of four, delivered by the Greater Cleveland Food Bank every two weeks. Based on participant preferences, includes recipes.
Financial SupportOther
Provides supplemental funds to purchase healthy foods; provides choice. Includes recipes for limited budgets and assistance locating healthy food options in their specific neighborhood.
| Study group | Role | What they receive |
|---|---|---|
| Food Delivery | Experimental | Food box delivered to participant home every 2 weeks until 6 weeks post delivery Receives: Behavioral: Food Delivery |
| Financial Support and Navigation | Experimental | $30 provide on gift card every two weeks until 6 weeks post delivery + neighborhood food retail navigation support. Receives: Other: Financial Support |
| Control Group | No intervention | Selected from claims data, matched. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Insecurity
6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome
Measured: Change from baseline to 10 weeks post-randomization
Food Insecurity
6 item, USDA measure; dichotomous outcome
Measured: Change from baseline to delivery
Maternal depression
9 item, self-administered, assesses maternal depression
Measured: Change from baseline to 10 weeks post-randomization
Maternal depression
9 item, self-administered, assesses maternal depression
Measured: Change from baseline to delivery
Social Support
6 item, self-administered, assesses emotional and instrumental social support
Measured: Change from baseline to 10 weeks post-randomization
Social Support
6 item, self-administered, assesses emotional and instrumental social support
Measured: Change from baseline to delivery
Mastery
7 item, self-administered, assesses skill development and locus of control
Measured: Change from baseline to 10 weeks post-randomization
Mastery
7 item, self-administered, assesses skill development and control
Measured: Change from baseline to delivery
Baby Birthweight
Baby's birthweight, measured in grams
Measured: At delivery
Baby Gestational Age
Baby's gestational age at birth, measured in weeks
Measured: At delivery
Neonatal Intensive Care (NICU) Utilization
number of days baby was admitted to NICU
Measured: From date of NICU admission to date of discharge from NICU or death, which ever comes first, up to 100 months
Days Hospitalization
total number of days baby was hospitalized following birth
Measured: From date of delivery to date of baby discharge from hospital or death, which ever comes first, up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Jul 2022
- Primary completion1 Apr 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- Better Health Partnership, Greater Cleveland Food Bank, Pregnancy with Possibilities Resource Center, Village of Healing Center, United Way of Greater Cleveland, MetroHealth Medical Center, Cleveland Department of Public Health
- Responsible party
- Principal investigator, Elaine Borawski, Case Western Reserve University
- Investigators
- Elaine A Borawski, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341960
- Sponsor's protocol ID
- STUDY20211072
- Status last verified
- Sep 2026
- First submitted
- 11 Apr 2022
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Borawski EA, Goodwin MA, Glenn AC, Mundorf C, Fernandez LI, Larberg N, Gunzler DD, Lever JS. Study design and protocol for Nourishing Beginnings, an integrated service delivery model addressing food insecurity and social needs of low-income pregnant individuals. Contemp Clin Trials. 2023 Oct;133:107310. doi: 10.1016/j.cct.2023.107310. Epub 2023 Aug 14.
PubMed 37586560
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nourishing Beginnings: Addressing Food Insecurity Among Medicaid-Eligible Pregnant Individuals
- ClinicalTrials.gov ID
- NCT05341960
- Acronym / sponsor ID
- STUDY20211072
- Keywords
- Food Insecurity, Community Health Workers, Food Delivery, Prenatal Nutrition, Social Determinants of Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- Better Health Partnership, Greater Cleveland Food Bank, Pregnancy with Possibilities Resource Center, Village of Healing Center, United Way of Greater Cleveland, MetroHealth Medical Center, Cleveland Department of Public Health
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 22 Apr 2022 (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.
This is a pilot project designed to test the feasibility of implementing a community health worker (CHW)-led intervention to improve nutritious food access and consumption among pregnant people and to evaluate the effectiveness of this approach. The project will be conducted in partnership with the Greater Cleveland Food Bank and the Better Health Partnership Community Health Worker HUB
Detailed description
The Nourishing Beginnings pilot study will enroll 160 pregnant individuals (<22 weeks gestation) who are eligible to use the Partnership Community HUB (i.e., Medicaid eligible). Participants will be randomly assigned into one of two intervention arms - either direct food delivery (n=80) or small financial resources and individualized navigation support for accessing local healthy foods (n=80).
The pilot will (1) assess the feasibility and allow protocol refinement; (2) assess the preliminary impact of CHW-led intervention; and (3) conduct a rigorous process evaluation of the implementation of the intervention using an effectiveness-implementation hybrid type 1 design. Dietary behavior, psychosocial health, health care utilization, and health outcomes and birth outcomes will be tracked at baseline, mid-pregnancy, and at delivery, derived from both primary and secondary data sources (i.e., Hub and claims data). Critical implementation points (referral, CHW touch points, and food delivery) will be assessed. Intervention arms will be compared to a matched comparison group derived from local claims data for the same time period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Food Delivery | Experimental | Behavioral: Food DeliveryFood box delivered to participant home every 2 weeks until 6 weeks post delivery |
| Financial Support and Navigation | Experimental | Other: Financial Support$30 provide on gift card every two weeks until 6 weeks post delivery + neighborhood food retail navigation support. |
| Control Group | No intervention | –Selected from claims data, matched. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medicaid eligible
- Enrolls in the CHW Hub
- Able to read and understand English
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food DeliveryFood box with food to feed a family of four, delivered by the Greater Cleveland Food Bank every two weeks. Based on participant preferences, includes recipes. | Behavioural | Food Delivery |
| Financial SupportProvides supplemental funds to purchase healthy foods; provides choice. Includes recipes for limited budgets and assistance locating healthy food options in their specific neighborhood. | Other | Financial Support and Navigation |
Primary outcome
Food Insecurity
Time frame: Change from baseline to 10 weeks post-randomization
6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome
Food Insecurity
Time frame: Change from baseline to delivery
6 item, USDA measure; dichotomous outcome
Maternal depression
Time frame: Change from baseline to 10 weeks post-randomization
9 item, self-administered, assesses maternal depression
Maternal depression
Time frame: Change from baseline to delivery
9 item, self-administered, assesses maternal depression
Social Support
Time frame: Change from baseline to 10 weeks post-randomization
6 item, self-administered, assesses emotional and instrumental social support
Social Support
Time frame: Change from baseline to delivery
6 item, self-administered, assesses emotional and instrumental social support
Mastery
Time frame: Change from baseline to 10 weeks post-randomization
7 item, self-administered, assesses skill development and locus of control
Mastery
Time frame: Change from baseline to delivery
7 item, self-administered, assesses skill development and control
Baby Birthweight
Time frame: At delivery
Baby's birthweight, measured in grams
Baby Gestational Age
Time frame: At delivery
Baby's gestational age at birth, measured in weeks
Neonatal Intensive Care (NICU) Utilization
Time frame: From date of NICU admission to date of discharge from NICU or death, which ever comes first, up to 100 months
number of days baby was admitted to NICU
Days Hospitalization
Time frame: From date of delivery to date of baby discharge from hospital or death, which ever comes first, up to 100 months
total number of days baby was hospitalized following birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Derived from this study: PubMed 37586560Borawski EA, Goodwin MA, Glenn AC, Mundorf C, Fernandez LI, Larberg N, Gunzler DD, Lever JS. Study design and protocol for Nourishing Beginnings, an integrated service delivery model addressing food insecurity and social needs of low-income pregnant individuals. Contemp Clin Trials. 2023 Oct;133:107310. doi: 10.1016/j.cct.2023.107310. Epub 2023 Aug 14.
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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.
Elaine A Borawski, PhD principal investigator
Case Western Reserve University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Delivery and Financial Support in people with Pregnancy Related and Food Insecurity, run by Case Western Reserve University at 2 sites 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 8 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 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Food Insecurity (time frame: Change from baseline to 10 weeks post-randomization). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05341960, which also lists 1 linked publication.
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 8 Sep 2026.