Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 12, 2020
Date Accepted: Jun 30, 2020
The Design of a Randomized Clinical Trial to Evaluate a Pragmatic and Scalable e-Health Intervention for Management of Gestational Weight Gain in Low-Income Women: SmartMoms in WIC
ABSTRACT
Background:
Less than one-third of women gain the appropriate amount of weight during pregnancy, which can influence the long-term health of both mother and child. Economically disadvantaged women are the most vulnerable to maternal obesity, excessive weight gain during pregnancy and poor birth outcomes. Effective and scalable healthcare 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 e-health trial, SmartMoms in WIC, designed to increase the rates of healthy gestational weight gain in low-income mothers receiving WIC benefits.
Methods:
Phase one of the trial included using feedback from Women, Infants, and Children (WIC) mothers and staff and participants from two community peer-advisory groups to adapt an existing e-health gestational weight management intervention to meet the needs of women receiving WIC benefits. The health curriculum, format of delivery, and incentive strategies were adapted to be culturally relevant and at an appropriate level of health literacy. Phase two is a pragmatic randomized control trial across the nine healthcare 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, exercise strategies, and provided technology to assist with weight management, delivered through a professionally produced website application.
Results:
Phase one of this trial was completed in July 2019 and recruitment for Phase two began immediately thereafter. All data is 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 e-health program on the incidence rates of appropriate gestational weight gain. SmartMoms in WIC may be able to offer an innovative, cost-effective and scalable solution for gestational weight gain management in women served by WIC. Clinical Trial: ClinicalTrials.gov NCT04028843; https://clinicaltrials.gov/ct2/show/NCT04028843
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