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| Name | Class |
|---|---|
| Better Health Partnership | UNKNOWN |
| Greater Cleveland Food Bank | UNKNOWN |
| Pregnancy with Possibilities Resource Center | UNKNOWN |
| Village of Healing Center |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Food Delivery | Experimental | Food box delivered to participant home every 2 weeks until 6 weeks post delivery |
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| Financial Support and Navigation | Experimental | $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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food Delivery | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Food Insecurity | 6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome | Change from baseline to 10 weeks post-randomization |
| Food Insecurity | 6 item, USDA measure; dichotomous outcome | Change from baseline to delivery |
| Maternal depression | 9 item, self-administered, assesses maternal depression | Change from baseline to 10 weeks post-randomization |
| Maternal depression | 9 item, self-administered, assesses maternal depression | Change from baseline to delivery |
| Social Support | 6 item, self-administered, assesses emotional and instrumental social support | Change from baseline to 10 weeks post-randomization |
| Social Support | 6 item, self-administered, assesses emotional and instrumental social support | Change from baseline to delivery |
| Mastery | 7 item, self-administered, assesses skill development and locus of control | Change from baseline to 10 weeks post-randomization |
| Mastery | 7 item, self-administered, assesses skill development and control |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Elaine A Borawski, PhD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mom's First | Cleveland | Ohio | 44106 | United States | ||
| Better Health Partnership CHW HUB |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37586560 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 19, 2021 | Apr 15, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D005378 | Financial Support |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
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| UNKNOWN |
| United Way of Greater Cleveland | UNKNOWN |
| MetroHealth Medical Center | OTHER |
| Cleveland Department of Public Health | UNKNOWN |
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| Financial Support | Other | Provides supplemental funds to purchase healthy foods; provides choice. Includes recipes for limited budgets and assistance locating healthy food options in their specific neighborhood. |
|
| Change from baseline to delivery |
| Baby Birthweight | Baby's birthweight, measured in grams | At delivery |
| Baby Gestational Age | Baby's gestational age at birth, measured in weeks | At delivery |
| Neonatal Intensive Care (NICU) Utilization | number of days baby was admitted to NICU | 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 | From date of delivery to date of baby discharge from hospital or death, which ever comes first, up to 100 months |
| Cleveland |
| Ohio |
| 44113 |
| United States |