Evaluation of Medicaid Food & Nutrition Support Program for Pregnant Women

NCT06368739 | Completed

• 1 other identifier: STUDY00005622
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

With funding from the Episcopal Health Foundation, the researchers will conduct a secondary data analysis to evaluate the impact of Driscoll Health Plan's Nurture program for pregnant members using claims data.

Conditions

Pregnancy Related; Financial Gift; Nutrition, Healthy

Keywords

gift card; nutrition education; nutrition consultation; food purchase; recipe; telephone; medicaid; health claims

Outcome Measures

Primary Outcomes (2)

• Composite outcome 1: Adverse health events during pregnancy

  Composite includes health claims (paid or non-paid) with codes related to: * Gestational Diabetes Mellitus * Excessive weight gain during pregnancy * Pregnancy-associated hypertension

  At pregnancy delivery

• Composite outcome 2: Adverse health events at birth and newborn-related

  Composite includes health claims (paid or non-paid) with codes related to: * Pre-term birth (\<37 weeks) * Neonatal Intensive Care Unit (NICU) * Small for gestational age * Large for gestational age * Stillbirths

  At pregnancy delivery

Other Outcomes (10)

• Emergency Department visits

  At pregnancy delivery

• Cost (outpatient)

  At pregnancy delivery

• Cost (inpatient)

  At pregnancy delivery

Study Arms (2)

Nurture + regular benefits (exposed group)

EXPERIMENTAL

1. Monthly packages sent every four weeks until end of pregnancy with maximum of eight packages. Each package includes: US $40 grocery store gift card A healthy eating information sheet selected from Brighter Bites project. (https://brighterbites.org/). A set of three recipes. Nutrition-related Frequently Asked Questions (in four of eight packages). 2. Two 30-minute telephonic nutritional consultations. Designed by a Registered Dietitian Nutritionist (RDN) who trained a bilingual nutrition specialist to deliver the consultations. Topics revolved around healthy eating during pregnancy, such as food choices, portion sizes, budget-friendly shopping, food safety, and food preparation. No nutrition therapy advice to manage diseases was provided. 3. Regular benefits Includes regular healthcare services offered as part of the health plan coverage with Medicaid/CHIP.

Behavioral: Nurture program; Other: Regular benefits

Regular benefits (comparison group)

ACTIVE COMPARATOR

Regular benefits Includes regular healthcare services offered as part of the health plan coverage with Medicaid/CHIP.

Other: Regular benefits

Interventions

Nurture program BEHAVIORAL

1. Nurture Monthly Packages: Sent every four weeks until the member reaches the end of pregnancy (delivery or other reasons, e.g., miscarriage), with a maximum of eight packages. Each package includes: * A US$40 gift card (2 x $20 each) to a grocery store. * A healthy eating information sheet selected from Brighter Bites project (https://brighterbites.org/). * A set of three recipes. * Nutrition-related Frequently Asked Questions (included in four out of the eight packages). 2. Two 30-Minute Nutritional Consultations over the phone: Designed by a Registered Dietitian Nutritionist (RDN) who trained a bilingual nutrition specialist to deliver the consultations. Topics revolved around healthy eating during pregnancy, such as food choices, portion sizes, budget-friendly shopping, food safety, and food preparation. No nutrition therapy advice to manage diseases was provided.

Nurture + regular benefits (exposed group)

Regular benefits OTHER

Includes regular healthcare services offered as part of the health plan coverage with Medicaid/CHIP.

Nurture + regular benefits (exposed group); Regular benefits (comparison group)

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Member of Driscoll Health Plan
• Pregnant
• Aged 30 or older

You may not qualify if:

• Not a member of Driscoll Health Plan
• Not pregnant
• Younger than 30 years of age

Sponsors & Collaborators

• University of Texas at Austin: lead
• Driscoll Health Plan: collaborator

Study Sites (1)

Driscoll Health Plan

Corpus Christi, Texas, 78415, United States

Location

Related Links

• Source of nutrition education materials included in the Nurture packages mailed to participants.

MeSH Terms

Conditions

Gift Giving

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: From the eligible population, DHP randomly selected a subset of approximately 500 women during the pilot period, from which approximately 200 were in the program, the "exposed group." The women who were covered during the same period but were not selected were not exposed to the program and will compose the "comparison group."

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: October 17, 2022
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)