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

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

Leigh Ann Simmons  1 , Jennifer E Phipps  2 , Courtney Overstreet  3 , Paige M Smith  2 , Elizabeth Bechard  4 , Siwei Liu  2 , Cheryl Walker  3 , Devon Noonan  5
Affiliations

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

Leigh Ann Simmons et al. Contemp Clin Trials. 2022 Feb.

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.

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Conflict of interest statement

Declaration of Competing Interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1.
Fig. 1.
Conceptual model for GROWell.
Fig. 2.
Fig. 2.
Overview of study design.
Fig. 3.
Fig. 3.
Example view of the mHealth platform and text messages.
See this image and copyright information in PMC

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