Evaluation of Medicaid Food & Nutrition Support Program for Pregnant Women

June 14, 2024 updated by: Maninder Kahlon, University of Texas at Austin

Evaluation of Medicaid Grocery Gift Cards & Nutrition Education Program for Pregnant Women on Maternal and Infant Outcomes

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.

Study Overview

Detailed Description

This record describes a quality improvement program (called "Nurture") piloted by Driscoll Health Plan, which included nutrition education and food purchase support offered to a subset of pregnant women aged 30 years and above and covered by the Medicaid Managed Care Organization (MCO) plan in their "STAR" and "CHIP" programs during October 2022 and July 2023.

Factor Health lab at Dell Medical School at the University of Texas at Austin will do a secondary data analysis to evaluate the impact of DHP's program.

Driscoll Health Plan (DHP) is a non-profit, community-based health insurance plan that provides coverage to South Texas and the Rio Grande Valley communities. Their insurance products include STAR Medicaid, STAR Kids, CHIP, and CHIP Perinatal.

With input from Factor Health lab at Dell Medical School, DHP introduced the Nurture program for its members as a quality improvement initiative, designed to expand members' access to nutrition education and food purchase support to improve health and pregnancy outcomes.

Nurture included up to 8 packages mailed every four weeks until the member reaches the end of pregnancy. Each package included USD $40 in the form of gift cards to a large-chain grocery store, a healthy eating information sheet selected from Brighter Bites (https://brighterbites.org/), a set of three recipes, and nutrition-related Frequently Asked Questions during pregnancy (in four out of the eight packages). Members also received two 30-minute nutritional consultations over the phone.

Members had the flexibility to opt out of the program at any time and discontinue receiving packages. Consultations were optional. If they opted out, they continued to receive the DHP benefits as part of their regular coverage.

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Corpus Christi, Texas, United States, 78415
        • Driscoll Health Plan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nurture + regular benefits (exposed group)
  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.
  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.
Includes regular healthcare services offered as part of the health plan coverage with Medicaid/CHIP.
Active Comparator: Regular benefits (comparison group)

Regular benefits

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite outcome 1: Adverse health events during pregnancy
Time Frame: At pregnancy delivery

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
Time Frame: At pregnancy delivery

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergency Department visits
Time Frame: At pregnancy delivery
Health claims with codes related to visits to emergency department.
At pregnancy delivery
Cost (outpatient)
Time Frame: At pregnancy delivery
Cost of outpatient services (e.g., primary care visits, screening) as available in paid health claims.
At pregnancy delivery
Cost (inpatient)
Time Frame: At pregnancy delivery
Cost of inpatient services (e.g., delivery) as available in paid health claims.
At pregnancy delivery
Cost (pharmacy/medication)
Time Frame: At pregnancy delivery
Cost of medication as available in paid health claims.
At pregnancy delivery
Cost (total)
Time Frame: At pregnancy delivery
Total cost of care as available in paid health claims.
At pregnancy delivery
Delivery mode (vaginal, C-section)
Time Frame: At pregnancy delivery
Health claims with codes related to mode of delivery.
At pregnancy delivery
Birthweight
Time Frame: At pregnancy delivery
Requested from hospital's electronic health records (as available)
At pregnancy delivery
Prenatal visits
Time Frame: At pregnancy delivery
Number of prenatal visits during study pregnancy
At pregnancy delivery
Gift card usage
Time Frame: 30 days after inactive from program
Binary response was gift card fully used
30 days after inactive from program
Nutritional consults attended
Time Frame: At pregnancy delivery
Categorical description of nutritional consults attended, both/one/none
At pregnancy delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2022

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

April 11, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Estimated)

June 18, 2024

Last Update Submitted That Met QC Criteria

June 14, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No data will be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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