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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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The overarching research question is: "Does the provision of healthy food (Delivering HOPE) during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with enhanced standard of care (ESoC)?" To answer this question, the investigators will conduct a large multi-site randomized controlled trial with 1,440 women. Women will be randomized to either the Delivering HOPE arm or the ESoC arm, with approximately 720 participants per arm. Participants randomized to the ESoC arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, WIC and SNAP enrollment assistance, referrals to safety net food organizations.Those randomized to the Delivering HOPE arm will be provided the same nutritional and gestational weight gain counseling, WIC and SNAP assistance, and food referrals, as well as a total of $1000/$2000/$3000 (depending on household size) during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. Data for the primary outcome (pre-pregnancy weight and weight at delivery) will be collected from birth records.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Standard of Care (ESoC) | Active Comparator | The ESoC arm includes implementing a standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women; implementing a standard protocol for helping participants sign up for WIC and SNAP; and implementing a standard protocol for providing referrals to safety net food organizations. |
|
| Delivering HOPE | Experimental | The Delivering HOPE arm includes providing the same nutritional and gestational weight gain counseling, WIC and SNAP assistance, and referral assistance as ESoC. In addition, participants in the Delivering HOPE arm will be provided with funds during their pregnancy to be used specifically for the purchase of healthy foods. The amount will vary based on household size as follows: $1,000 (one to two household members), $2,000 (three to four household members), or $3,000 (five plus household members). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Standard of Care (ESoC) | Behavioral | Standard recommended nutrition and gestational weight gain counseling; WIC and SNAP enrollment assistance; emergency food referrals |
| Measure | Description | Time Frame |
|---|---|---|
| Excessive gestational weight gain (EGWG) | Pre-pregnancy weight and weight immediately prior to birth will be used to calculate total weight gain, adjusting for pre-pregnancy body mass index and weeks of gestation. Individuals whose total weight gain exceeds established guidelines will be determined to have EGWG. We will examine the difference in the proportion of women who experience EGWG. | Baseline to Post-partum (approx. 40 weeks) |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brett Rowland | Contact | 479-713-8000 | mbrowland@uams.edu | |
| Sarah Pollock | Contact | 479-713-8000 | SPollack@uams.edu |
| Name | Affiliation | Role |
|---|---|---|
| Pearl McElfish, PhD | University of Arkansas | Principal Investigator |
| Lanita White, PharmD | Community Health Centers of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st Choice Healthcare | Recruiting | Corning | Arkansas | 72422 | United States |
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| Delivering HOPE | Behavioral | ESoC plus healthy food provision |
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| River Valley Primary Care Services | Recruiting | Lavaca | Arkansas | 72941 | United States |
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| Olly Neal Community Health Center | Recruiting | Marianna | Arkansas | 72360 | United States |
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| Boston Mountain Rural Health Center | Recruiting | Marshall | Arkansas | 72650 | United States |
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| Mainline Health Systems | Recruiting | Monticello | Arkansas | 71655 | United States |
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| Jefferson Comprehensive Care System | Withdrawn | Pine Bluff | Arkansas | 71601 | United States |
| Community Clinic | Recruiting | Springdale | Arkansas | 72764 | United States |
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| East Arkansas Family Health Center | Recruiting | West Memphis | Arkansas | 72301 | United States |
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| ID | Term |
|---|---|
| D000078064 | Gestational Weight Gain |
| D046110 | Hypertension, Pregnancy-Induced |
| D016640 | Diabetes, Gestational |
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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