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| Name | Class |
|---|---|
| Family Health Council of Central Pennsylvania (FHCCP) | UNKNOWN |
| American Heart Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Arm 3: Clinic-RDN Model | Active Comparator | Clinical team gives WIC information only; connects patient to registered dietitian/nutritionist (RDN) |
|
| Arm 4: Clinic-WIC-RDN | Active Comparator | Clinical team connects patient to WIC and RDN |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WIC Referral | Behavioral | Clinical team will refer study participants to WIC |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| WIC retention | Number of WIC benefit pick up visits completed | 6 months |
| WIC adherence | Frequency of redeeming WIC benefit | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa D Bailey-Davis | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Health System | Danville | Pennsylvania | 17822 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42360744 | Derived | 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. | |
| 39639285 |
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All individual participant data collected during the trial will be shared, after de-identification.
Data will be made available immediately following publication. No end date.
Anyone who wishes to access the data may access for any purpose.
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D000079262 | Pregnancy in Obesity |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009765 | Obesity |
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| RDN Referral | Behavioral | Clinical team will refer study participants to a RDN |
|
| Prenatal clinic visit adherence. | Number of prenatal clinic visits attended | 6 months |
| Registered Dietitian/Nutritionist (RDN) visit adherence | Number of RDN visits completed | 6 months |
| Herb 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. |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |