eMoms: Electronically-mediated weight interventions for pregnant and postpartum women. Study design and baseline characteristics

Abstract

Background

The influence of childbearing in the development of obesity is situated within two different but related contexts: pregnancy-related weight gain and weight gain prevention and control in young adult women. Pregnancy related weight gain contributes to long-term weight retention in childbearing women.

Objective

To present the study design, data collection procedures, recruitment challenges, and the baseline characteristics for the eMoms of Rochester study, a randomized clinical trial testing the effect of electronically-mediated behavioral interventions to prevent excessive gestational weight gain (GWG) and postpartum weight retention among women aged 18–35 years of diverse income and racial/ethnic backgrounds in an urban setting.

Design

Randomized double blind clinical trial. A total of 1722 women at or below 20 weeks of gestation were recruited primarily from obstetric practices and randomized to 3 treatment groups: control arm; intervention arm with access to intervention during pregnancy and control at postpartum (e-intervention 1); and intervention arm with access to intervention during pregnancy and postpartum (e-intervention 2). Enrollment and consent were completed via study staff or online. Data were collected via online surveys, medical charts, and measurement of postpartum weights. The primary endpoints are gaining more weight than recommended by the Institution of Medicine guidelines and weight retained at 12 months postpartum.

Conclusion

This study will provide evidence on the efficacy of behavioral interventions in the prevention of excessive GWG and postpartum weight retention with potential dissemination to obstetric practices and/or health insurances.

ClinicalTrials.gov #NCT01331564.

Introduction

The influence of pregnancy in the development of obesity is at the intersection of two research areas: pregnancy-related weight gain and weight gain prevention and control in young adult women. Approximately 53% of pregnant women gain more weight during pregnancy [1] than recommended by the Institute of Medicine (IOM) (Table 1) [2]. Excessive gestational weight gain (GWG) is associated with maternal and offspring morbidity, including postpartum weight retention and childhood obesity [3], [4], [5], [6], [7], [8], [9], [10]. Longitudinal data indicate that women gain a considerable amount of weight during their twenties and thirties [11] and that parity is associated with weight and waist circumference increases [12].

Several trials have tested the effect of lifestyle interventions during pregnancy on weight accumulation. Randomized and non-randomized trials suggest that educational interventions comprised of physical activity (PA) and dietary counseling during pregnancy, commonly combined with weight monitoring, may lower the risk of excessive GWG [13], [14], [15]. Similarly, postpartum trials of both diet and PA or diet alone were effective in minimizing weight retention after childbirth [16]. To our knowledge, few studies have examined the effect of a combined pregnancy and postpartum intervention on GWG and postpartum weight retention [17] adapting the interventions to the lifestyle changes involved in transitioning from pregnancy to postpartum life [18]. eMoms of Rochester trial (eMoms) was designed to fill this gap.

The objective of the eMoms study was to slow the accumulation of weight in childbearing women during pregnancy and the postpartum period by decreasing the prevalence of excessive GWG and minimizing postpartum weight retention in a socio-economically and racially/ethnically diverse sample of women. eMoms is part of the National Heart, Lung, and Blood Institute Early Adult Reduction of weight through LifestYle interventions (EARLY) consortium of weight control studies that tested innovative intervention approaches that incorporated digital technologies among young adults aged 18–35 to facilitate recruitment and retention [19]. In addition to using digital technologies for most of the study procedures (e.g., enrollment, intervention delivery, adverse event reporting), eMoms has other unique features such as a three arm design, a large sample size to examine differential effects by subgroup, and a long follow-up period. The purpose of this report is to present the eMoms study design, data collection procedures, recruitment challenges, and the baseline characteristics of the study sample.