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NCT Number: NCT05341960

Nourishing Beginnings: Addressing Food Insecurity During Pregnancy

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pregnancy Related Female Urogenital Diseases and Pregnancy Complications Food Insecurity Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Better Health Partnership CHW HUB, Cleveland, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medicaid eligible
  • Enrolls in the CHW Hub
  • Able to read and understand English

Exclusion criteria

-

Treatment and study plan

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.

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.

Primary outcomes

  1. Food Insecurity

    Time frame: Change from baseline to 10 weeks post-randomization

    6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome

  2. Food Insecurity

    Time frame: Change from baseline to delivery

    6 item, USDA measure; dichotomous outcome

  3. Maternal depression

    Time frame: Change from baseline to 10 weeks post-randomization

    9 item, self-administered, assesses maternal depression

  4. Maternal depression

    Time frame: Change from baseline to delivery

    9 item, self-administered, assesses maternal depression

  5. Social Support

    Time frame: Change from baseline to 10 weeks post-randomization

    6 item, self-administered, assesses emotional and instrumental social support

  6. Social Support

    Time frame: Change from baseline to delivery

    6 item, self-administered, assesses emotional and instrumental social support

  7. Mastery

    Time frame: Change from baseline to 10 weeks post-randomization

    7 item, self-administered, assesses skill development and locus of control

  8. Mastery

    Time frame: Change from baseline to delivery

    7 item, self-administered, assesses skill development and control

  9. Baby Birthweight

    Time frame: At delivery

    Baby's birthweight, measured in grams

  10. Baby Gestational Age

    Time frame: At delivery

    Baby's gestational age at birth, measured in weeks

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • Better Health Partnership
  • Cleveland Department of Public Health
  • Greater Cleveland Food Bank
  • MetroHealth Medical Center
  • Pregnancy with Possibilities Resource Center
  • United Way of Greater Cleveland
  • Village of Healing Center

Registry information

Official study title

Nourishing Beginnings: Addressing Food Insecurity Among Medicaid-Eligible Pregnant Individuals

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2022
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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