Goals for Reaching Optimal Wellness (GROWell): A clinical trial protocol of a digital dietary intervention for pregnant and postpartum people with prenatal overweight or obesity

Contemp Clin Trials. 2022 Feb;113:106627. doi: 10.1016/j.cct.2021.106627. Epub 2021 Nov 20.

Abstract

Background: Excess gestational weight gain (EGWG) is associated with multiple pregnancy complications and health risks for birthing people and their infants. Likewise, postpartum weight retention (PPWR), or not losing all pregnancy weight, has long-term health consequences. EGWG among people 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 protocol describes the details of a blinded, randomized clinical trial of GROWell: Goals for Reaching Optimal Wellness, a mHealth tool designed to improve diet quality among people who enter pregnancy with overweight or obese BMIs to help them achieve appropriate GWG and safe postpartum pregnancy weight loss. Individuals with overweight and obesity will be randomly assigned to an attention control or intervention arm. The intervention group will receive personalized, 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, follow up, 3 and 6 months postpartum.

Results and discussion: Currently, 162 subjects have been enrolled. Outcomes associated with GWG and pregnancy are expected in late 2023, while outcomes on postpartum weight retention GROWell adherence are expected in late 2024. The results of this trial will support the use of an evidence-based mHealth tool to be integrated into clinical practice to reduce EGWG and PPWR among pregnant people with overweight and obese BMIs, a resource that is currently lacking.

Trial registration: ClinicalTrials.gov identifier: NCT04449432. Registered on June 26, 2020.

Keywords: Gestational weight gain; Mobile health intervention; Obesity; Overweight; Postpartum weight retention; Pregnancy.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural

MeSH terms

  • Female
  • Gestational Weight Gain*
  • Goals
  • Humans
  • Infant
  • Obesity / complications
  • Obesity / therapy
  • Overweight / complications
  • Overweight / therapy
  • Postpartum Period
  • Pregnancy
  • Pregnancy Complications* / therapy
  • Randomized Controlled Trials as Topic

Associated data

  • ClinicalTrials.gov/NCT04449432