Pregnancy RelatedNCT06368739
Evaluation of Medicaid Food & Nutrition Support Program for Pregnant Women
A study testing Nurture program and Regular benefits in people with Pregnancy Related and Financial Gift, run by University of Texas at Austin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Pregnancy Related, Financial Gift, Nutrition, Healthy
- What is being tested?
- Nurture program and Regular benefits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2022to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Member of Driscoll Health Plan
- Pregnant
- Aged 30 or older
Who cannot join
- Not a member of Driscoll Health Plan
- Not pregnant
- Younger than 30 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy Related, Financial Gift, Nutrition, Healthy
- Being tested
- Nurture program, Regular benefits
- Keywords
- gift card, nutrition education, nutrition consultation, food purchase, recipe, telephone, medicaid, health claims
- Medical subject headings
- Gift Giving
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurture programBehavioural
- 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.
Regular benefitsOther
Includes regular healthcare services offered as part of the health plan coverage with Medicaid/CHIP.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Regular benefits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: At pregnancy delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start17 Oct 2022
- Primary completion1 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Driscoll Health Plan
- Responsible party
- Principal investigator, Maninder Kahlon, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368739
- Sponsor's protocol ID
- STUDY00005622
- Status last verified
- Mar 2025
- First submitted
- 11 Apr 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Medicaid Grocery Gift Cards & Nutrition Education Program for Pregnant Women on Maternal and Infant Outcomes
- ClinicalTrials.gov ID
- NCT06368739
- Acronym / sponsor ID
- STUDY00005622
- Conditions
- Pregnancy Related, Financial Gift, Nutrition, Healthy
- Keywords
- gift card, nutrition education, nutrition consultation, food purchase, recipe, telephone, medicaid, health claims
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Driscoll Health Plan
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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."
| Arm | Type | Receives |
|---|---|---|
| Nurture + regular benefits (exposed group) | Experimental | Behavioral: Nurture program, Other: Regular benefits1. 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. |
| Regular benefits (comparison group) | Active comparator | Other: Regular benefitsRegular benefits Includes regular healthcare services offered as part of the health plan coverage with Medicaid/CHIP. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Member of Driscoll Health Plan
- Pregnant
- Aged 30 or older
Key exclusion criteria (3 listed)
- Not a member of Driscoll Health Plan
- Not pregnant
- Younger than 30 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurture program1. 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. | Behavioural | Nurture + regular benefits (exposed group) |
| Regular benefitsIncludes regular healthcare services offered as part of the health plan coverage with Medicaid/CHIP. | Other | Nurture + regular benefits (exposed group), Regular benefits (comparison group) |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Source of nutrition education materials included in the Nurture packages mailed to participants.Link provided by the sponsor.
- Individual participant dataSharing planned: No. No data will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurture program and Regular benefits in people with Pregnancy Related and Financial Gift, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome 1: Adverse health events during pregnancy (time frame: At pregnancy delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.