Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 1, 2022
Date Accepted: Jul 12, 2022
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Study Protocol for a Randomized Controlled Trial of Grocery Delivery to Support Healthy Weight Gain among Pregnant Young Women with Low-Income
ABSTRACT
Background:
Excessive weight gain during pregnancy is associated with complications for both the mother and her infant including gestational diabetes, hypertensive disorders, operative delivery, and long-term obesity. Healthy diet during pregnancy promotes healthy gestational weight gain and determines fetal epigenetic programming in infants that impacts risk for future chronic disease.
Objective:
This project will examine the impact of grocery delivery during pregnancy on the weight, diet, and health outcomes for young pregnant women and their infants.
Methods:
A three arm randomized controlled trial design will be performed. 855 young pregnant women, aged 14-24, from across the state of Michigan will be enrolled and randomized equally into the three study arms. Participants in arm one (control) will receive usual care from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), arm two will receive WIC plus biweekly grocery delivery, and arm three will receive WIC plus biweekly grocery and unsweetened beverage delivery. Weight will be assessed weekly during pregnancy and total pregnancy weight gain will be categorized as above, below, or within guidelines. Additionally, dietary intake will be assessed at three time points (baseline, 2nd trimester, 3rd trimester) and pregnancy outcomes will be extracted from medical records. Appropriateness of pregnancy weight gain, diet quality, and occurrence of poor outcomes will be compared between groups using standard practices for multinomial regression and confounder adjustment.
Results:
This study was funded in April 2021, data collection started in December 2021, and data collection is expected to be concluded in 2026.
Conclusions:
This study will test whether grocery delivery of healthy foods improves weight, diet, and pregnancy outcomes in young moms with low-income. Findings will inform policies and practices that promote a healthy diet during pregnancy, which has multi-generational impacts on health. Clinical Trial: ClinicalTrials.gov: NCT05000645. Registered August 11, 2021
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