Goals for Reaching Optimal Wellness (GROWell): A Clinical Trial Protocol of a Digital Dietary Intervention for Pregnant and Postpartum Women with Prenatal Overweight or Obesity

Abstract Background: Excess gestational weight gain (GWG) is associated with many pregnancy complications and health risks for mothers and infants. Likewise, postpartum weight retention (PPWR) has long-term health consequences for women. Excess GWG among women who enter pregnancy with overweight or obesity have worse obstetric outcomes and increased PPWR compared to women who gain within Institute of Medicine guidelines. Methods: This study is a blinded, randomized clinical trial of GROWell: Goals for Reaching Optimal Wellness, a mHealth tool designed to improve diet quality among women who enter pregnancy with overweight or obese BMIs in order to help them achieve appropriate GWG and safe postpartum pregnancy weight loss. Overweight and obese (BMI B25 and <40) women with singleton, uncomplicated pregnancies will be recruited and randomly assigned to an attention control or intervention arm. The intervention group will receive goal-oriented text messages regarding dietary choices, while the attention control group will receive text messages about healthy pregnancy, labor, delivery and early infancy. Both groups will complete online surveys at baseline (26-28 weeks), follow up (36-38 weeks), 3 months postpartum, and 6 months postpartum.Discussion: This study protocol describes the details of the GROWell randomized clinical trial. The results of this trial will provide data to support the use of an evidence-based mHealth tool to be integrated into clinical practice to reduce excess GWG and PPWR among pregnant women with overweight and obese BMIs, a resource that is currently lacking.Trial registration: ClinicalTrials.gov identifier: NCT04449432. Registered on June 26, 2020.