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://clinicaltrials.gov/ct2/show/NCT04028843 International Registered Report Identifier (IRRID): DERR1-10.2196/18211
Preeclampsia (PE) is a serious hypertensive disorder of pregnancy characterized by abnormal placental development with an unknown etiology. To better understand which women will develop PE, a number of maternal risk factors have been identified, including obesity. Visceral white adipose tissue (WAT) contains inflammatory mediators that may contribute to PE. To explore this, we utilized the blood pressure high (BPH)/5 mouse model of superimposed PE that spontaneously recapitulates the maternal PE syndrome. We hypothesized that BPH/5 visceral WAT adjacent to the female reproductive tract (reproductive WAT) is a source of complement factors that contribute to the inflammatory milieu and angiogenic imbalance at the maternal–fetal interface in this model and in preeclamptic women. To test our hypothesis, we calorie-restricted BPH/5 females for two weeks prior to pregnancy and the first seven days of pregnancy, which attenuated complement component 3 (C3) but not complement factor B, nor complement factor D, (adipsin) in the reproductive WAT or the implantation site in BPH/5. Furthermore, calorie restriction during pregnancy restored vascular endothelial and placental growth factor mRNA levels in the BPH/5 implantation site. These data show maternal reproductive WAT may be a source of increased C3 during pregnancy, which is increased at the maternal–fetal interface in preeclamptic BPH/5 mice. It also suggests that calorie restriction could regulate inflammatory mediators thought to contribute to placental dysfunction in PE. Future studies are necessary to examine the effect of calorie restriction on C3 throughout pregnancy and the role of maternal obesity in PE.
Readability of infant formula preparation instructions is universally poor, which may result in inaccurate infant feeding. Given that inaccurate formula dispensing can lead to altered infant growth and increased adiposity, there is an increased need for easy to follow instructions for formula preparation. We hypothesize that altering infant formula instruction labels using feedback from iterative focus groups will improve the preparation accuracy of powdered infant formula in a randomized controlled trial. Participants were recruited from the community, 18 years of age or older, willing to disclose demographic information for focus group matching, and willing to participate freely in the first (n = 21) or second (n = 150) phase of the study. In the second phase, participants were randomized to use the standard manufacturer instructions or to use the modified instructions created in the first phase. Accuracy was defined as the percent error between manufacturer-intended powder formula quantity and the amount dispensed by the participant. Participants who were assigned to the modified instructions were able to dispense the powdered formula more accurately than participants who used the standard manufacturer instructions (−0.67 ± 0.76 vs. −4.66 ± 0.74% error; p < 0.0001). Accuracy in powdered formula dispensing was influenced by bottle size (p = 0.02) but not by body mass index (p = 0.17), education level (p = 0.75), income (p = 0.7), age (p = 0.89) or caregiver status (p = 0.18). Percent error of water measurement was not different between the groups (standard: −1.4 ± 0.6 vs. modified: 0.7 ± 0.6%; p = 0.38). Thus, caloric density was more accurate in the modified instructions group compared to the standard manufacturer instructions group (−0.3 ± 0.6 vs.−2.9 ± 0.9%; p = 0.03). Infant formula label modifications using focus group feedback increased infant formula preparation accuracy.
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. CLINICALTRIAL ClinicalTrials.gov NCT04028843; https://clinicaltrials.gov/ct2/show/NCT04028843 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/18211