- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06368739
Evaluation of Medicaid Food & Nutrition Support Program for Pregnant Women
Evaluation of Medicaid Grocery Gift Cards & Nutrition Education Program for Pregnant Women on Maternal and Infant Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Texas
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Corpus Christi, Texas, United States, 78415
- Driscoll Health Plan
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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)
|
Includes regular healthcare services offered as part of the health plan coverage with Medicaid/CHIP.
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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
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Composite includes health claims (paid or non-paid) with codes related to:
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At pregnancy delivery
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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:
|
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.
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At pregnancy delivery
|
Cost (inpatient)
Time Frame: At pregnancy delivery
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Cost of inpatient services (e.g., delivery) as available in paid health claims.
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At pregnancy delivery
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Cost (pharmacy/medication)
Time Frame: At pregnancy delivery
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Cost of medication as available in paid health claims.
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At pregnancy delivery
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Cost (total)
Time Frame: At pregnancy delivery
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Total cost of care as available in paid health claims.
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At pregnancy delivery
|
Delivery mode (vaginal, C-section)
Time Frame: At pregnancy delivery
|
Health claims with codes related to mode of delivery.
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At pregnancy delivery
|
Birthweight
Time Frame: At pregnancy delivery
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Requested from hospital's electronic health records (as available)
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At pregnancy delivery
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Prenatal visits
Time Frame: At pregnancy delivery
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Number of prenatal visits during study pregnancy
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At pregnancy delivery
|
Gift card usage
Time Frame: 30 days after inactive from program
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Binary response was gift card fully used
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30 days after inactive from program
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Nutritional consults attended
Time Frame: At pregnancy delivery
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Categorical description of nutritional consults attended, both/one/none
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At pregnancy delivery
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00005622
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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