Evaluation of Medicaid Food & Nutrition Support Program for Pregnant Women

• ClinicalTrials.gov Identifier: NCT06368739
• Recruitment Status: Active, not recruiting
• First Posted: April 16, 2024
• Last Update Posted: April 16, 2024
• Sponsor: University of Texas at Austin
• Collaborator: Driscoll Health Plan
• Information provided by (Responsible Party): Maninder Kahlon, University of Texas at Austin

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pregnancy Related; Financial Gift; Nutrition, Healthy	Behavioral: Nurture program; Other: Regular benefits	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 224 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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."
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Evaluation of Medicaid Grocery Gift Cards & Nutrition Education Program for Pregnant Women on Maternal and Infant Outcomes
• Actual Study Start Date: October 17, 2022
• Estimated Primary Completion Date: May 1, 2024
• Estimated Study Completion Date: August 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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

Other Outcome Measures:

1. Emergency Department visits [ Time Frame: At pregnancy delivery ]
   Health claims with codes related to visits to emergency department.
2. Cost (outpatient) [ Time Frame: At pregnancy delivery ]
   Cost of outpatient services (e.g., primary care visits, screening) as available in paid health claims.
3. Cost (inpatient) [ Time Frame: At pregnancy delivery ]
   Cost of inpatient services (e.g., delivery) as available in paid health claims.
4. Cost (pharmacy/medication) [ Time Frame: At pregnancy delivery ]
   Cost of medication as available in paid health claims.
5. Cost (total) [ Time Frame: At pregnancy delivery ]
   Total cost of care as available in paid health claims.
6. Delivery mode (vaginal, C-section) [ Time Frame: At pregnancy delivery ]
   Health claims with codes related to mode of delivery.
7. Birthweight [ Time Frame: At pregnancy delivery ]
   Requested from hospital's electronic health records (as available)

Eligibility Criteria

• Ages Eligible for Study: 30 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Member of the Driscoll Health Plan, pregnant, aged 30 or older

Exclusion Criteria:

• Not a member of the Driscoll Health Plan, not pregnant, younger than 30 years of age

Contacts and Locations

Locations

United States, Texas

Driscoll Health Plan

Corpus Christi, Texas, United States, 78415

Sponsors and Collaborators

University of Texas at Austin

Driscoll Health Plan

  Study Documents (Full-Text)

Documents provided by Maninder Kahlon, University of Texas at Austin:

Study Protocol and Statistical Analysis Plan  [PDF] January 24, 2024

More Information

Additional Information:

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

• Responsible Party: Maninder Kahlon, Associate Professor, University of Texas at Austin
• ClinicalTrials.gov Identifier: NCT06368739
• Other Study ID Numbers: STUDY00005622
• First Posted: April 16, 2024
• Last Update Posted: April 16, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No data will be shared with other researchers.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maninder Kahlon, University of Texas at Austin:

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