Healthy for Two/Healthy for You: Design and methods for a pragmatic randomized clinical trial to limit gestational weight gain and prevent obesity in the prenatal care setting.

OBJECTIVE: To compare the effect of Healthy for Two/Healthy for You (H42/H4U), a health coaching program, in prenatal care clinics that serve a racially and economically diverse population, on total gestational weight gain (GWG) (vs. usual care). We hypothesize that compared to usual prenatal care, intervention participants will have lower GWG and lower rates of gestational diabetes mellitus (GDM). METHODS: We report the rationale and design of a pragmatic, parallel arm randomized clinical trial with 380 pregnant patients ≤15 weeks gestation with overweight or obesity from one of 6 academic and community-based obstetrics practices, randomized to either H42/H4U or usual prenatal care in a 1:1 ratio. The study duration is early pregnancy to 6 months postpartum. The primary outcome is total GWG, calculated as the difference between first clinic-assessed pregnancy weight and the weight at 37 weeks gestation. Key maternal and infant secondary outcomes include GDM incidence, weight retention at 6 months postpartum, infant weight, maternal health behaviors and wellness. CONCLUSIONS: This pragmatic clinical trial embeds a pregnancy health coaching program into prenatal care to allow parallel testing compared to usual prenatal care on the outcome of total GWG. The real-world design provides an approach to enhance its sustainability beyond the trial to ultimately improve maternal/child health outcomes and reduce future obesity. TRIAL REGISTRATION: The study was first registered at clinicaltrials.gov on 1/26/21 (NCT04724330).

Erratum: Author Correction: Use of a Launderable Bed Barrier and Antibiotic Stewardship to Decrease Hospital Onset Clostridioides difficile Infections in an Acute Care Hospital: A Retrospective Pre/Post Case Study.

[This corrects the article DOI: 10.36469/001c.11149.].

Use of a Launderable Bed Barrier and Antibiotic Stewardship to Decrease Hospital Onset Clostridioides difficile Infections in an Acute Care Hospital: A Retrospective Pre-Post Case Study.

BACKGROUND: Hospital-onset Clostridioides difficile infection (HO-CDI) is a major source of morbidity and mortality. The objective of this research was to evaluate the reduction in HO-CDI through the use of a launderable bed barrier (BB) and an antibiotic stewardship program (ASP). METHODS: A retrospective pre-post study was conducted at an acute care hospital in Kentucky. The preintervention period was September 2014 through March 2016. The BB and the ASP were introduced in April 2016, and the post-intervention period for this study ended September 2018. The rate of HO-CDI was calculated from the actual number of HO-CDI divided by the number of patient days each month. The number of defined daily doses of antibiotic therapy was measured each quarter. Hand disinfection compliance, length-of-stay (LOS), case mix index (CMI), and average age of patients were collected to control for confounding in the regression models. RESULTS: There were 34 HO-CDIs and 42 672 patient days in the pre-intervention period and 31 HO-CDIs and 65 882 patient days in the post-intervention period. The average monthly count of HO-CDI was 1.79 (SD 1.51) and 1.03 (SD 0.96) during the pre- and post-periods, respectively. The average monthly rate (per 10 000 patient-days) was 7.94 (SD 6.30) in the pre-intervention period and 4.71 (SD 4.42) during the post-intervention period. The use of antibiotics decreased by 37% (p <0.0001) over the study period. The combination of the BB and the ASP were associated with a 59% (95% CI 36-96%, p 0.034) reduction in HO-CDI. CONCLUSIONS: The use of a launderable BB and the ASP were associated with a statistically and clinically significant reduction in HO-CDI in the acute care hospital setting.