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

ABSTRACT: 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.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.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.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.

SUBMITTER: Fernandez ID

PROVIDER: S-EPMC5353854 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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

Fernandez Isabel Diana ID Groth Susan W SW Reschke Jennifer E JE Graham Meredith L ML Strawderman Myla M Olson Christine M CM

Contemporary clinical trials 20150506

<h4>Background</h4>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.<h4>Objective</h4>To present the study design, data collection procedures, recruitment challenges, and the baseline characteristics for the eMoms of Rochester study, a randomized cl ...[more]

PMID: 25957183

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Project description:IntroductionPregnant and postpartum women face major psychological stressors that put them at higher risk of developing common mental disorders, such as depression and anxiety. Yet, their limited access to and uptake of traditional mental health care is inequitable, especially during the COVID-19 pandemic. Mobile interventions emerged as a potential solution to this discontinued healthcare access, but more knowledge is needed about their effectiveness and impact on health equity. This equity-focused systematic review examined the effectiveness and equity impact of mobile interventions targeting common mental disorders among pregnant and postpartum women.Methods and resultsWe systematically searched MEDLINE, EMBASE, PsychINFO and 3 other databases, from date of database inception and until January 2021, for experimental studies on mobile interventions targeting pregnant and postpartum women. We used pooled and narrative synthesis methods to analyze effectiveness and equity data, critically appraised the methodological rigour of included studies using Cochrane tools, and assessed the certainty of evidence using the GRADE approach. Our search identified 6148 records, of which 18 randomized and non-randomized controlled trials were included. Mobile interventions had a clinically important impact on reducing the occurrence of depression (OR = 0.51 [95% CI 0.41 to 0.64]; absolute risk reduction RD: 7.14% [95% CI 4.92 to 9.36]; p<0.001) and preventing its severity perinatally (MD = -3.07; 95% CI -4.68 to -1.46; p<0.001). Mobile cognitive behavioural therapy (CBT) was effective in managing postpartum depression (MD = -6.87; 95% CI -7.92 to -5.82; p<0.001), whereas other support-based interventions had no added benefit. Results on anxiety outcomes and utilization of care were limited. Our equity-focused analyses showed that ethnicity, age, education, and being primiparous were characteristics of influence to the effectiveness of mobile interventions.ConclusionAs the COVID-19 pandemic has increased the need for virtual mental health care, mobile interventions show promise in preventing and managing common mental disorders among pregnant and postpartum women. Such interventions carry the potential to address health inequity but more rigorous research that examines patients' intersecting social identities is needed.

Project description:BackgroundThe emergence and utilization of electronic health (eHealth) technologies has increased in a variety of health interventions. Exploiting the real-time advantages offered by mobile technologies during and after pregnancy has the potential to empower women and encourage behaviors that may improve maternal and child health.ObjectiveThe objective of this study was to assess the effectiveness of eHealth technologies for weight management during pregnancy and the postpartum period and to review the efficacy of eHealth technologies on health behaviors, specifically nutrition and physical activity.MethodsA systematic search was conducted of the following databases: MEDLINE, EMBASE, Cochrane database of systematic reviews (CDSR), Cochrane central register of controlled trials (CENTRAL), CINAHL (Cumulative Index to Nursing and Allied Health Literature), and PsycINFO. The search included studies published from 1990 to July 5, 2016. All relevant primary studies that involved randomized controlled trials (RCTs), non-RCTs, before-and-after studies, historically controlled studies, and pilot studies were included. The study population was adult women of childbearing age either during pregnancy or the postpartum period. eHealth weight management intervention studies targeting physical activity, nutrition, or both, over a minimum 3-month period were included. Titles and abstracts, as well as full-text screening were conducted. Study quality was assessed using Cochrane's risk of bias tool. Data extraction was completed by a single reviewer, which was then verified by a second independent reviewer. Results were meta-analyzed to calculate pooled estimates of the effect, wherever possible.ResultsOverall, 1787 and 176 citations were reviewed at the abstract and full-text screening stages, respectively. A total of 10 studies met the inclusion criteria ranging from high to low risk of bias. Pooled estimates from studies of the effect for postpartum women resulted in a significant reduction in weight (-2.55 kg, 95% CI -3.81 to -1.28) after 3 to 12 months and six studies found a nonsignificant reduction in weight gain for pregnant women (-1.62 kg, 95% CI -3.57 to 0.33) at approximately 40 weeks.ConclusionsThis review found evidence for benefits of eHealth technologies on weight management in postpartum women only. Further research is still needed regarding the use of these technologies during and after pregnancy.

Project description:BackgroundWeight stigma is a societal phenomenon that is very prevalent in healthcare, precipitating poor patient-provider relationships, discontinuity of care, and delayed cancer screening. Little research, though, has investigated weight stigma in prenatal and postpartum healthcare. To address this gap, this study examined the prevalence and frequency of weight-stigmatizing experiences in prenatal and postpartum healthcare.Methods501 pregnant and postpartum women responded to an online survey where they reported whether they had experienced weight stigma in prenatal or postpartum healthcare and, if so, how frequently. Participants also responded to questions about how providers had treated them regarding their weight and their reactions to these experiences. A subset of participants (n = 80) also provided examples of their experiences, and these were subjected to a thematic analysis and coded for overarching themes.ResultsNearly 1 in 5 women (n = 92) reported experiencing weight stigma in healthcare settings. Percentages differed by BMI, with 28.4% of participants with pre-pregnancy obesity endorsing healthcare providers as a source of weight stigma. Experiences occurred between "less than once a month" and "a few times a month." Obstetricians were the most commonly-reported source (33.8%), followed by nurses (11.3%). Participants reported feeling judged, shamed, and guilty because of their weight during healthcare visits. Additionally, 37 participants (7.7%) reported having changed providers because of treatment regarding their weight. Many also reported that they expected to feel or had felt uncomfortable seeking help with breastfeeding from a healthcare professional. Finally, thematic analysis of the open-ended examples identified four key themes: (1) negative attitudes and unkind or disrespectful treatment from providers; (2) evaluative comments about their weight; (3) healthcare providers focusing on their high-risk status and potential negative consequences (often when birth outcomes were ultimately healthy); and (4) inappropriate or demeaning comments.ConclusionsWeight stigma may be a common experience in pregnancy and postpartum healthcare. Providers need additional training to avoid stigmatizing their patients and inadvertently undermining patient-provider relationships, quality of care, and health outcomes.

Project description:Obesity is an important public health concern with limited effective treatment options. Internet-based technologies offer a cost-effective means to treat obesity. However, most of the online programs have been of short duration, have focused on a limited number of treatment modalities, and have not utilized the potential of coaching as part of the intervention. In this paper, we present the design, methods and participants' baseline characteristics in a real-life internet-based weight management program. Healthy Weight Coaching (HWC) is a 12-month web-based intervention for the management of obesity. The program is based on the Acceptance and Commitment Therapy and includes themes important for weight loss, including diet, physical activity, psychological factors, and sleep. In addition to the automated, interactive program, a personal coach is allocated to each participant. The participants are nationally enrolled through referrals from primary care, occupational health, hospitals, and private health care units. Adult individuals with BMI ?25 kg/m2 without severe complications are included. On a weekly basis, participants submit their weight logs, training sessions, and lifestyle targets to the internet portal and are scheduled to have online discussions with their coaches 26 times over the course of a year. Questionnaires on lifestyle, diet, physical activity, psychological factors, sleep, and quality of life are completed at baseline, 3, 6, 9, and 12 months, and thereafter yearly until 5 years. Additionally, log data on the use of the service and discussions with the coach are collected. The main outcome is weight change from baseline to 12 months. Recruitment to the HWC is ongoing. Baseline data of the participants recruited between Oct 2016 and Mar 2019 (n = 1189) are provided. This research will bring insight into how internet-based technologies can be implemented in the virtual management of obesity. Trial registration:The trial is registered at clinicaltrials.cov (Clinical Trials Identifier NCT04019249).

Project description:BACKGROUND:The safety, efficacy, and appropriate timing of isoniazid therapy to prevent tuberculosis in pregnant women with human immunodeficiency virus (HIV) infection who are receiving antiretroviral therapy are unknown. METHODS:In this multicenter, double-blind, placebo-controlled, noninferiority trial, we randomly assigned pregnant women with HIV infection to receive isoniazid preventive therapy for 28 weeks, initiated either during pregnancy (immediate group) or at week 12 after delivery (deferred group). Mothers and infants were followed through week 48 after delivery. The primary outcome was a composite of treatment-related maternal adverse events of grade 3 or higher or permanent discontinuation of the trial regimen because of toxic effects. The noninferiority margin was an upper boundary of the 95% confidence interval for the between-group difference in the rate of the primary outcome of less than 5 events per 100 person-years. RESULTS:A total of 956 women were enrolled. A primary outcome event occurred in 72 of 477 women (15.1%) in the immediate group and in 73 of 479 (15.2%) in the deferred group (incidence rate, 15.03 and 14.93 events per 100 person-years, respectively; rate difference, 0.10; 95% confidence interval [CI], -4.77 to 4.98, which met the criterion for noninferiority). Two women in the immediate group and 4 women in the deferred group died (incidence rate, 0.40 and 0.78 per 100 person-years, respectively; rate difference, -0.39; 95% CI, -1.33 to 0.56); all deaths occurred during the postpartum period, and 4 were from liver failure (2 of the women who died from liver failure had received isoniazid [1 in each group]). Tuberculosis developed in 6 women (3 in each group); the incidence rate was 0.60 per 100 person-years in the immediate group and 0.59 per 100 person-years in the deferred group (rate difference, 0.01; 95% CI, -0.94 to 0.96). There was a higher incidence in the immediate group than in the deferred group of an event included in the composite adverse pregnancy outcome (stillbirth or spontaneous abortion, low birth weight in an infant, preterm delivery, or congenital anomalies in an infant) (23.6% vs. 17.0%; difference, 6.7 percentage points; 95% CI, 0.8 to 11.9). CONCLUSIONS:The risks associated with initiation of isoniazid preventive therapy during pregnancy appeared to be greater than those associated with initiation of therapy during the postpartum period. (Funded by the National Institutes of Health; IMPAACT P1078 TB APPRISE ClinicalTrials.gov number, NCT01494038.).

Project description:ObjectiveTo evaluate elvitegravir and cobicistat pharmacokinetics during pregnancy compared with postpartum and in infant washout samples after delivery.DesignNonrandomized, open-label, parallel-group, multicenter phase-IV prospective study of antiretroviral pharmacokinetics in HIV-infected pregnant women and their children in the United States.MethodsIntensive steady-state 24-h pharmacokinetic profiles after 150 mg of elvitegravir and 150 mg of cobicistat given orally in fixed dose combination once-daily were performed during the second trimester, third trimester, and postpartum. Infant washout samples were collected after birth. Elvitegravir and cobicistat were measured in plasma by a validated liquid chromatography with tandem mass spectrometry assay with a lower quantitation limit of 10 ng/ml. A two-tailed Wilcoxon signed-rank test (α = 0.10) was employed for paired within-participant comparisons.ResultsThirty pregnant women taking elvitegravir and cobicistat once-daily enrolled in the study. Compared with paired postpartum data, elvitegravir AUC0-24 was 24% lower in the second trimester [n = 14, P = 0.058, geometric mean ratios (GMR) = 0.76, 90% confidence interval (CI) 0.57-1.0] and 44% lower in the third trimester (n = 24, P = 0.0001, GMR = 0.56, 90% CI 0.42-0.73), while cobicistat AUC0-24 was 44% lower in the second trimester (n = 14, P = 0.0085, GMR = 0.56, 90% CI 0.37-0.85) and 59% lower in the third trimester (n = 24, P < 0.0001, GMR = 0.41, 90% CI 0.30-0.57). Median cord blood elvitegravir concentration was 540.6 ng/ml and the median ratio of cord blood to maternal plasma elvitegravir concentrations was 0.91.ConclusionStandard elvitegravir and cobicistat dosing during pregnancy results in significantly lower exposure which may increase the risk of virologic failure and mother-to-child transmission. Additional studies are needed to optimize elvitegravir and cobicistat dosing regimens in pregnant women.

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

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

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