Cardiovascular DiseasesFIMPregNCT06311799
Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy
A study testing WIC Referral and RDN Referral in people with Cardiovascular Diseases and Obesity, Maternal, run by Geisinger Clinic at 1 site in United States.
Trial summary
This study is being done to find out if online referrals to a food management program for Women, Infants, and Children (WIC) made by clinical teams will get more people to enroll in WIC. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cardiovascular Diseases, Obesity, Maternal, Diabetes
- What is being tested?
- WIC Referral and RDN Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2024to 31 Dec 2025
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- Confirmed pregnancy
- Public Insurance (Medicaid) OR no insurance
- If no insurance, must meet income eligibility for WIC
- Intent to deliver at a Geisinger facility
- Able and willing to provide consent
Who cannot join
- Pre-existing WIC enrollment as a pregnant person
- Not eligible for WIC
- Private insurance
- Unwilling to participate for up to 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Health System
Danville, Pennsylvania, 17822
About this study
This study is being done to find out if online referrals to a food management program for Women, Infants, and Children (WIC) made by clinical teams will get more people to enroll in WIC. Women aged 18 or older who get healthcare at Geisinger, are pregnant, and are eligible to be referred to the WIC program will be recruited. These women need to consent to join this study. There are four groups in this study. Group 1 will get usual care with details about WIC from their clinical team. Group 2 will be sent to WIC by their clinical team. The study team may help the clinical team with the referrals. Group 3 will get details about WIC from their clinical team and a dietitian will talk to them about heart-healthy diets and food management. Group 4 will be sent to WIC by their clinical team or study team and a dietitian will talk to them about heart-healthy diets and food management. Participants who talk with the dietitians will be sent kitchen utensils based on need. This study will last about 18 months and will have 240 total subjects joining at about 60 per month. Each subject will be in the study for about 6 months. Subjects will be asked to complete surveys at the start and end of the study. Some subjects will also be asked about their experience in the study after they are done.
- Conditions
- Cardiovascular Diseases, Obesity, Maternal, Diabetes
- Being tested
- WIC Referral, RDN Referral
- Medical subject headings
- Cardiovascular Diseases, Pregnancy in Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WIC ReferralBehavioural
Clinical team will refer study participants to WIC
RDN ReferralBehavioural
Clinical team will refer study participants to a RDN
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Clinic Model | No intervention | Clinical team gives WIC information only |
| Arm 2: Clinic-WIC Model | Active comparator | Clinical team connects patient to WIC Receives: Behavioral: WIC Referral |
| Arm 3: Clinic-RDN Model | Active comparator | Clinical team gives WIC information only; connects patient to registered dietitian/nutritionist (RDN) Receives: Behavioral: RDN Referral |
| Arm 4: Clinic-WIC-RDN | Active comparator | Clinical team connects patient to WIC and RDN Receives: Behavioral: WIC Referral; Behavioral: RDN Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Women, Infants, and Children (WIC) enrollment
Difference in WIC enrollment between Arm 1 and Arm 3 (Information only) vs Arm 2 and Arm 4 (digital connections)
Measured: 6 months
Secondary outcomes (4)
WIC retention
Number of WIC benefit pick up visits completed
Measured: 6 months
WIC adherence
Frequency of redeeming WIC benefit
Measured: 6 months
Prenatal clinic visit adherence.
Number of prenatal clinic visits attended
Measured: 6 months
Registered Dietitian/Nutritionist (RDN) visit adherence
Number of RDN visits completed
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start29 Apr 2024
- Primary completion30 Jun 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Family Health Council of Central Pennsylvania (FHCCP), American Heart Association
- Responsible party
- Sponsor
- Investigators
- Lisa D Bailey-Davis, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311799
- Sponsor's protocol ID
- 2024-0102
- Acronym
- FIMPreg
- Status last verified
- Dec 2025
- First submitted
- 8 Mar 2024
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data collected during the trial will be shared, after de-identification.
Publications
Bailey-Davis L, Mackeen AD, Herb Neff KM, Brandt K, Ditchey A, Lutcher S, Marshall KA, Matrey N, Seiler CJ, Cook A, Welch M, Wood GC, Wright L, Chang AR. Direct Digital Referrals From Prenatal Care and WIC Enrollment Among Pregnant Individuals: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jun 1;9(6):e2620138. doi: 10.1001/jamanetworkopen.2026.20138.
PubMed 42360744Herb Neff KM, Brandt K, Chang AR, Lutcher S, Mackeen AD, Marshall KA, Naylor A, Seiler CJ, Wood GC, Wright L, Bailey-Davis L. Comparing models that integrate obstetric care and WIC on improved program enrollment during pregnancy: a protocol for a randomized controlled trial. BMC Public Health. 2024 Dec 5;24(1):3393. doi: 10.1186/s12889-024-20509-6.
PubMed 39639285
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy
- ClinicalTrials.gov ID
- NCT06311799
- Acronym / sponsor ID
- FIMPreg / 2024-0102
- Conditions
- Cardiovascular Diseases, Obesity, Maternal, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- Family Health Council of Central Pennsylvania (FHCCP), American Heart Association
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 15 Mar 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.
This study is being done to find out if online referrals to a food management program for Women, Infants, and Children (WIC) made by clinical teams will get more people to enroll in WIC. Women aged 18 or older who get healthcare at Geisinger, are pregnant, and are eligible to be referred to the WIC program will be recruited. These women need to consent to join this study. There are four groups in this study. Group 1 will get usual care with details about WIC from their clinical team. Group 2 will be sent to WIC by their clinical team. The study team may help the clinical team with the referrals. Group 3 will get details about WIC from their clinical team and a dietitian will talk to them about heart-healthy diets and food management. Group 4 will be sent to WIC by their clinical team or study team and a dietitian will talk to them about heart-healthy diets and food management. Participants who talk with the dietitians will be sent kitchen utensils based on need. This study will last about 18 months and will have 240 total subjects joining at about 60 per month. Each subject will be in the study for about 6 months. Subjects will be asked to complete surveys at the start and end of the study. Some subjects will also be asked about their experience in the study after they are done.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Clinic Model | No intervention | –Clinical team gives WIC information only |
| Arm 2: Clinic-WIC Model | Active comparator | Behavioral: WIC ReferralClinical team connects patient to WIC |
| Arm 3: Clinic-RDN Model | Active comparator | Behavioral: RDN ReferralClinical team gives WIC information only; connects patient to registered dietitian/nutritionist (RDN) |
| Arm 4: Clinic-WIC-RDN | Active comparator | Behavioral: WIC Referral, Behavioral: RDN ReferralClinical team connects patient to WIC and RDN |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- English speaking
- Confirmed pregnancy
- Public Insurance (Medicaid) OR no insurance
- If no insurance, must meet income eligibility for WIC
- Intent to deliver at a Geisinger facility
Key exclusion criteria (4 listed)
- Pre-existing WIC enrollment as a pregnant person
- Not eligible for WIC
- Private insurance
- Unwilling to participate for up to 12 months
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 |
|---|---|---|
| WIC ReferralClinical team will refer study participants to WIC | Behavioural | Arm 2: Clinic-WIC Model, Arm 4: Clinic-WIC-RDN |
| RDN ReferralClinical team will refer study participants to a RDN | Behavioural | Arm 3: Clinic-RDN Model, Arm 4: Clinic-WIC-RDN |
Primary outcome
Difference in Women, Infants, and Children (WIC) enrollment
Time frame: 6 months
Difference in WIC enrollment between Arm 1 and Arm 3 (Information only) vs Arm 2 and Arm 4 (digital connections)
4 secondary outcomes
WIC retention
Time frame: 6 months
WIC adherence
Time frame: 6 months
Prenatal clinic visit adherence.
Time frame: 6 months
Registered Dietitian/Nutritionist (RDN) visit adherence
Time frame: 6 months
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 2 Jan 2026.
- Derived from this study: PubMed 42360744Bailey-Davis L, Mackeen AD, Herb Neff KM, Brandt K, Ditchey A, Lutcher S, Marshall KA, Matrey N, Seiler CJ, Cook A, Welch M, Wood GC, Wright L, Chang AR. Direct Digital Referrals From Prenatal Care and WIC Enrollment Among Pregnant Individuals: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jun 1;9(6):e2620138. doi: 10.1001/jamanetworkopen.2026.20138.
- Derived from this study: PubMed 39639285Herb Neff KM, Brandt K, Chang AR, Lutcher S, Mackeen AD, Marshall KA, Naylor A, Seiler CJ, Wood GC, Wright L, Bailey-Davis L. Comparing models that integrate obstetric care and WIC on improved program enrollment during pregnancy: a protocol for a randomized controlled trial. BMC Public Health. 2024 Dec 5;24(1):3393. doi: 10.1186/s12889-024-20509-6.
- Individual participant dataSharing planned: Yes. All individual participant data collected during the trial will be shared, after de-identification.
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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.
Lisa D Bailey-Davis principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WIC Referral and RDN Referral in people with Cardiovascular Diseases and Obesity, Maternal, run by Geisinger Clinic 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 6 inclusion and 4 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 2 Jan 2026. 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?
Difference in Women, Infants, and Children (WIC) enrollment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06311799, which also lists 2 linked publications.
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 2 Jan 2026.