The Design of a Randomized Clinical Trial to Evaluate a Pragmatic and Scalable eHealth Intervention for the Management of Gestational Weight Gain in Low-Income Women: Protocol for the SmartMoms in WIC Trial

Emily W Flanagan, Abby D Altazan, Natalie R Comardelle, L Anne Gilmore, John W Apolzan, Jessica St Romain, Julie C Hardee, Renee S Puyau, Christy L Mayet, Robbie A Beyl, S Ariel Barlow, Sarah Surber Bounds, Kelsey N Olson, Betty M Kennedy, Daniel S Hsia, Leanne M Redman, Emily W Flanagan, Abby D Altazan, Natalie R Comardelle, L Anne Gilmore, John W Apolzan, Jessica St Romain, Julie C Hardee, Renee S Puyau, Christy L Mayet, Robbie A Beyl, S Ariel Barlow, Sarah Surber Bounds, Kelsey N Olson, Betty M Kennedy, Daniel S Hsia, Leanne M Redman

Abstract

Background: Less than one-third of women gain an appropriate amount of weight during pregnancy, which can influence the long-term health of both the mother and the child. Economically disadvantaged women are the most vulnerable to maternal obesity, excessive weight gain during pregnancy, and poor birth outcomes. Effective and scalable health care strategies to promote healthy weight gain during pregnancy specifically tailored for these women are lacking.

Objective: This paper presents the design and protocol of a biphasic, community-based eHealth trial, SmartMoms in WIC, to increase the adherence to healthy gestational weight gain (GWG) recommendations in low-income mothers receiving women, infant, and children (WIC) benefits.

Methods: Phase 1 of the trial included using feedback from WIC mothers and staff and participants from 2 community peer advisory groups to adapt an existing eHealth gestational weight management intervention to meet the needs of women receiving WIC benefits. The health curriculum, the format of delivery, and incentive strategies were adapted to be culturally relevant and at an appropriate level of health literacy. Phase 2 included a pragmatic randomized controlled trial across the 9 health care regions in Louisiana with the goal of enrolling 432 women. The SmartMoms in WIC intervention is an intensive 24-week behavioral intervention, which includes nutrition education and exercise strategies, and provides the technology to assist with weight management, delivered through a professionally produced website application.

Results: Phase 1 of this trial was completed in July 2019, and recruitment for phase 2 began immediately thereafter. All data are anticipated to be collected by Spring 2023.

Conclusions: The SmartMoms in WIC curriculum was methodically developed using feedback from community-based peer advisory groups to create a culturally relevant, mobile behavioral intervention for mothers receiving WIC benefits. The randomized clinical trial is underway to test the effectiveness of a sustainable eHealth program on the incidence rates of appropriate GWG. SmartMoms in WIC may be able to offer an innovative, cost-effective, and scalable solution for GWG management in women served by WIC.

Trial registration: ClinicalTrials.gov NCT04028843; https://ichgcp.net/clinical-trials-registry/NCT04028843.

International registered report identifier (irrid): DERR1-10.2196/18211.

Keywords: community health; gestational weight gain; maternal obesity; mobile health; mobile phone.

Conflict of interest statement

Conflicts of Interest: LR, the principal investigator of this research study, is also a coinventor of the SmartMoms technology. LR does not currently have any financial gain from SmartMoms; however, it is currently available for licensing through LSU-Pennington. If a license is acquired, LR may possibly receive a royalty payment. All other authors have no conflicts of interest to declare.

©Emily W Flanagan, Abby D Altazan, Natalie R Comardelle, L Anne Gilmore, John W Apolzan, Jessica St. Romain, Julie C Hardee, Renee S Puyau, Christy L Mayet, Robbie A Beyl, S Ariel Barlow, Sarah Surber Bounds, Kelsey N Olson, Betty M Kennedy, Daniel S Hsia, Leanne M Redman. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 10.09.2020.

Figures

Figure 1
Figure 1
Two phases of the SmartMoms in WIC Trial.
Figure 2
Figure 2
Daily weight charts and visual feedback for a. adherence to recommended rates of weight gain receives an illuminated green light as a visual cue b. above adherence to recommended weight gain receives an illuminated red light as a visual cue c. above recommended rates of weight gain but on a trajectory that is approaching recommended rates of weight gain receives an illuminated yellow light as a visual cue d. weight gain within recommended bounds once again receives an illuminated green light as a visual cue.

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Source: PubMed

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