RESUMEN
BACKGROUND: Interventions to prevent excessive gestational weight gain (GWG) have had a limited impact on maternal and infant outcomes. Dietary fiber is a nutrient with benefits that counters many of the metabolic and inflammatory changes that occur during pregnancy. We will determine if a high dietary fiber (HFib) intervention provides benefit to maternal and infant outcomes. METHODS AND DESIGN: Pregnant women will be enrolled in an 18-week intervention and randomized in groups of 6-10 women/group into the intervention or control group. Weekly lessons will include information on high-dietary fiber foods and behavior change strategies. Women in the intervention group will be given daily snacks high in dietary fiber (10-12 g/day) to facilitate increasing dietary fiber intake. The primary aim will assess between-group differences for the change in maternal weight, dietary fiber intake, dietary quality, and body composition during pregnancy and up to two months post-partum. The secondary aim will assess between-group differences for the change in maternal weight, dietary fiber intake, and dietary quality from two months to one year post-partum and infant body composition from birth to one-year-old. DISCUSSION: Effective and simple intervention strategies to improve maternal and offspring outcomes are lacking. Changes during the perinatal period are related to the risk of disease development in the mother and offspring. However, it is unknown which changes can be successfully targeted to have a meaningful impact. We will test the effect of an intervention designed to counter many of the metabolic and inflammatory changes that occur during pregnancy. ETHICS AND DISSEMINATION: The University of Kansas Medical Center Institutional Review Board (IRB) approved the study protocol (STUDY00145397). The results of the trial will be disseminated at conferences and in peer reviewed publications. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04868110.