TY - JOUR
T1 - 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
T2 - Protocol for the SmartMoms in WIC trial
AU - Flanagan, Emily W.
AU - Altazan, Abby D.
AU - Comardelle, Natalie R.
AU - Anne Gilmore, L.
AU - Apolzan, John W.
AU - St. Romain, Jessica
AU - Hardee, Julie C.
AU - Puyau, Renee S.
AU - Mayet, Christy L.
AU - Beyl, Robbie A.
AU - Ariel Barlow, S.
AU - Bounds, Sarah Surber
AU - Olson, Kelsey N.
AU - Kennedy, Betty M.
AU - Hsia, Daniel S.
AU - Redman, Leanne M.
N1 - Funding Information:
A pilot trial conducted at Pennington Biomedical Research Center (PBRC) in Baton Rouge, Louisiana, showed the efficacy of SmartMoms, an intensive behavioral smartphone intervention to reduce excess GWG in pregnant women with overweight or obesity when compared with delivery via a traditional in-person approach [15]. Notably, as compared with SmartMoms delivered in person, women receiving SmartMoms through a smartphone were more adherent (76.5% vs 60.8%). This trial also showed that a GWG intervention is more cost-effective when delivered through a smartphone device compared with delivery via in-person sessions (smartphone: US $97, SD US $6 vs in person: US $347, SD US $40). In response to the US National Institutes of Health solicitation for research focused on Maternal Nutrition and Pre-pregnancy Obesity: Effect on Mothers, Infants, and Children (PA-18-135), we developed a randomized controlled trial titled: A pragmatic, scalable e-health intervention for management of gestational weight gain in low-income mothers (SmartMoms in WIC). The clinical trial is registered at ClinicalTrials.gov (NCT04028843). This work is supported by the National Institutes of Health (R01NR017644) and core support via U54GM104940 and P30DK072476.
Publisher Copyright:
©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. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
PY - 2020/9
Y1 - 2020/9
N2 - 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.
AB - 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.
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U2 - 10.2196/18211
DO - 10.2196/18211
M3 - Article
C2 - 32909954
AN - SCOPUS:85091882300
SN - 1929-0748
VL - 9
JO - JMIR Research Protocols
JF - JMIR Research Protocols
IS - 9
M1 - e18211
ER -