Abstract
Purpose The purpose of this feasibility study is to determine the magnitude of effect using a combination of weekly weights and an online registered dietician to control excessive gestational weight gain in pregnant women with obesity using a pilot randomized controlled trial. Specific Aims There are three specific aims. Aim 1: Describe the study population in terms of sociodemographic influences (e.g., ethnicity, age, weight, and height) and obstetrical influences (i.e., parity and pregnancy weight). Aim 2: Measure participant satisfaction with the study interventions of weekly weighing and online nutrition counselling. Aim 3: (a) Explore the differences in gestational weight gain from enrollment to 6 weeks later and at 28 weeks among pregnant women with obesity who were not given any special nutrition counseling or scale (historical controls) to those given scales and asked to weigh themselves weekly; (b) explore if there were any differences in gestational weight gain among the intervention group, between those who receive nutrition counseling and those who did not; (c) determine the effect size of the interventions for a future larger RCT. Background Approximately 1/3 of pregnancy complications are related to obesity (Ramachenderan et al., 2008). For example, the odds of developing gestational diabetes increases 7.7 times. For every 5-7 unit increase in maternal BMI the risk for preeclampsia doubles (Bautista-Castano et al., 2013), and the risk of having a cesarean delivery increases 2-3 times for women whose BMI is greater than 30 (Ovesen et al., 2011). Employing a Registered Dietician (RD) for weight management during pregnancy has demonstrated success, although the use of online dieticians remains untested (Vincze et al., 2019). Methods Pregnant women between 14-36 weeks gestation, with a BMI greater than 30 will be included in the study. Recruitment will occur remotely through the use of a recruitment flyer with a QR code. Participants will scan the QR, complete a survey for eligibility, and consent for the study online. Women will be randomly assigned to either the self weighing group or self-weighing and online nutritional counseling intervention group. Self-weighing will occur through the use of a preconfigured Bluetooth scale and data will be stored and retrieved through a secure data hub. Online nutritional counseling will occur through a secure telehealth platform, and occur for 30 minutes, once a week, for six weeks. For the control group, retrospective data will be extracted from an electronic medical record. Variables measured include gestational weight gain after
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