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Feasibility of a Diet Intervention Trial During Pregnancy in a Rural Population: The PEAPOD Pilot Study (P11-013-19).

Objectives
Healthy pregnancy diet is important for infant development, but maternal dietary effects on establishment of the infant gut microbiome are not well understood. Our goal was to test the feasibility of conducting a randomized controlled trial (RCT) to implement a diet intervention and collect survey data and biospecimens from pregnant women and their infants.


Methods
Employing a 2-arm RCT, we recruited women (n = 27) in mid-pregnancy from a prenatal care clinic, randomized participants to the intervention (n = 13) or to usual care (n = 14), and followed to 6 wks postpartum. Data collection included surveys, maternal blood, urine, and stool at three time points (T1 = 25 and T2 = 36 wks gestation [pre- and 4 wks post-intervention initiation, respectively]; T3 = 6 wks postpartum), and infant stool at 6 wks. The intervention was initiated at 32 wks gestation and continued until birth of the baby. In wk 1, participants received non-perishable high fiber foods (whole wheat cereal, oatmeal, dried fruit, canned beans) as well as olive oil, vinegar, recipes for salad dressing and side dishes, and general nutrition information. Partnering with a hospital catering service, the intervention included weekly food delivery of 3 large prepared salads, 2 quarts of soup including either legumes or whole grains (e.g., beans, barley), and 5 pieces of fresh fruit (e.g., apples, oranges).


Results
Our sample is considered entirely rural and maternal characteristics reflected the local population: 100% White, 17% Hispanic or Native American; 89% at least some college; 26% Medicaid; 33% ever smoked. Mean maternal age was 29.6 y (range 20-40 y), mean pre-pregnancy BMI was 26.9 kg/m2 (range 18.5-41.6). Data collection adherence was high with few missing data points: T1 = 100% for survey, blood, urine, stool; T2 = 93% for stool, 96% for blood and urine; T3 = 93% for survey, blood, urine, and stool). Overall satisfaction was high with 85% reporting satisfied or very satisfied and important qualitative insights were gained from participants.


Conclusions
This pilot trial produced valuable information to effectively refine the intervention so that it can be tested in a larger, longer study using a factorial design to test the effects of pregnancy diet and/or postpartum diet of breastfeeding moms on the establishment of the infant microbiome.


Funding Sources
MSU internal funds (AgBioResearch and faculty start-up).