Food Insecurity, Pregnancy Complications, Pregnancy Related, Premature Birth
Conditions
Keywords
Food Insecurity, Community Health Workers, Food Delivery, Prenatal Nutrition, Social Determinants of Health
Brief 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. 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.
Interventions
BEHAVIORALFood Delivery
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.
OTHERFinancial Support
Provides supplemental funds to purchase healthy foods; provides choice. Includes recipes for limited budgets and assistance locating healthy food options in their specific neighborhood.
Sponsors
Case Western Reserve University
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 design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Medicaid eligible * Enrolls in the CHW Hub * Able to read and understand English
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Food Insecurity | Change from baseline to 10 weeks post-randomization | 6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome |
| Maternal depression | Change from baseline to 10 weeks post-randomization | 9 item, self-administered, assesses maternal depression |
| Social Support | Change from baseline to 10 weeks post-randomization | 6 item, self-administered, assesses emotional and instrumental social support |
| Mastery | Change from baseline to 10 weeks post-randomization | 7 item, self-administered, assesses skill development and locus of control |
| Baby Birthweight | At delivery | Baby's birthweight, measured in grams |
| Baby Gestational Age | At delivery | Baby's gestational age at birth, measured in weeks |
| Neonatal Intensive Care (NICU) Utilization | 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 | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElaine A Borawski, PhD
Case Western Reserve University
Outcome results
None listed