University of Arkansas
The overarching research question is: "Does the provision of healthy food during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with standard of care (SoC)?" To answer this question, the investigators will conduct a cluster-randomized controlled trial with 400 pregnant women who are enrolled in CenteringPregnancy classes. CenteringPregnancy classes (clusters) will be randomized to either the Food Provision arm or the SoC arm, with approximately 200 participants per arm. Participants randomized to the SoC arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, as well as $500 after delivery to be used specifically for baby items.Those randomized to the Food Provision arm will be provided the same nutritional and gestational weight gain counseling, as well as a total of $1000 during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. Data for the primary outcome will be collected from birth records and from surveys conducted at baseline (pre-intervention), midpoint (between 24-36 weeks gestation), and post-intervention (\~8 weeks post-partum).
Pregnancy Complications
Excessive Gestational Weight Gain
Standard of Care (SoC)
Food Provision
NA
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 400 participants |
| Masking : | NONE |
| Primary Purpose : | PREVENTION |
| Official Title : | Arkansas Community Engagement Alliance: Delivering Arkansas Perinatal Outcomes for Minority and Rural Women Through Innovative System Improvement to Create Equity |
| Actual Study Start Date : | 2025-06 |
| Estimated Primary Completion Date : | 2028-03-31 |
| Estimated Study Completion Date : | 2028-03-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 16 Years to 44 Years |
| Sexes Eligible for Study: | FEMALE |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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