Evaluation of Medicaid Food & Nutrition Support Program for Pregnant Women

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06368739
• Other study ID #: STUDY00005622
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: June 2024
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 224
• Est. completion date: August 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

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.

Locations

Country	Name	City	State
United States	Driscoll Health Plan	Corpus Christi	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	Driscoll Health Plan

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

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