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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
124
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.
Provides supplemental funds to purchase healthy foods; provides choice. Includes recipes for limited budgets and assistance locating healthy food options in their specific neighborhood.
Mom's First
Cleveland, Ohio, United States
RECRUITINGBetter Health Partnership CHW HUB
Cleveland, Ohio, United States
RECRUITINGFood Insecurity
6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome
Time frame: Change from baseline to 10 weeks post-randomization
Food Insecurity
6 item, USDA measure; dichotomous outcome
Time frame: Change from baseline to delivery
Maternal depression
9 item, self-administered, assesses maternal depression
Time frame: Change from baseline to 10 weeks post-randomization
Maternal depression
9 item, self-administered, assesses maternal depression
Time frame: Change from baseline to delivery
Social Support
6 item, self-administered, assesses emotional and instrumental social support
Time frame: Change from baseline to 10 weeks post-randomization
Social Support
6 item, self-administered, assesses emotional and instrumental social support
Time frame: Change from baseline to delivery
Mastery
7 item, self-administered, assesses skill development and locus of control
Time frame: Change from baseline to 10 weeks post-randomization
Mastery
7 item, self-administered, assesses skill development and control
Time frame: Change from baseline to delivery
Baby Birthweight
Baby's birthweight, measured in grams
Time frame: At delivery
Baby Gestational Age
Baby's gestational age at birth, measured in weeks
Time frame: At delivery
Neonatal Intensive Care (NICU) Utilization
number of days baby was admitted to NICU
Time frame: 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
Time frame: From date of delivery to date of baby discharge from hospital or death, which ever comes first, up to 100 months
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