Study protocol for a multisite randomized controlled trial of an internet and mobile‐based intervention for preventing and reducing perinatal depressive symptoms

Nearly 20% of women in the United States experience clinically significant depressive symptoms during pregnancy or the postpartum period. These women may benefit from easily accessible, nonpharmacologic, and inexpensive self‐management approaches, such as via internet and mobile‐based interventions, to prevent development of symptoms and/or intervene with current symptoms. This paper summarizes the research protocol of a nationally‐funded large‐scale randomized controlled study to evaluate “Mamma Mia,” a self‐guided program with 44 modules that women use throughout pregnancy to 6 months postpartum. The program contains a novel combination of components designed to enable women to enhance self‐efficacy, emotional self‐regulation, and perceived social support. The overall goal of this three‐arm longitudinal randomized controlled trial is to evaluate the effects and mechanisms of this self‐management approach in diverse women in the U.S. (n = 1950). Enrolled pregnant women will be randomly assigned to one of three groups: (1) “Mamma Mia” alone, which is self‐guided; (2) “Mamma Mia Plus” in which participants engage in the “Mamma Mia” modules plus receive brief guided support from a registered nurse; or (3) usual prenatal/postpartum care. The first specific aim is to evaluate effects by group on the primary outcome of interest, depressive symptoms, over time. The second aim is to evaluate effects by group on subjective well‐being, anxiety, and stress. Using a conceptual framework based upon Individual and Family Self‐Management Theory, the third aim is to evaluate possible mediators (self‐efficacy, emotion self‐regulation, perceived support) and possible moderators (e.g., race/ethnicity, type of healthcare clinician) of this self‐management approach.     

Overestimation of the 25(OH)D serum concentration with the automated IDS EIA kit

We have recently observed an increasing number of patients presenting very high serum levels of 25‐hydroxyvitamin D [25(OH)D] (> 150 ng/mL), which, in all cases, had been measured with the IDS EIA kit adapted on different “open” automated platforms. We performed a comparison between the IDS EIA kit adapted on two different “open”automated platforms and the DiaSorin RIA. We found a systematic bias (higher levels with the IDS EIA kit) for concentrations more than 50–60 ng/mL that was less obvious when the IDS EIA was used in its manual procedure. We thus suggest to use the IDS EIA kit in its manual procedure rather than to adapt it on an automated platform, and to interpret cautiously a 25(OH)D greater than 100 ng/mL with this kit. © 2011 American Society for Bone and Mineral Research.     

From good ideas to actions: A model-driven community collaborative to prevent childhood obesity

ObjectiveActivate Omaha Kids, a community collaborative, was designed, implemented, and evaluated with the aim of preventing childhood obesity in the Omaha community. Activate Omaha Kids brought together key stakeholders and community leaders to create a community coalition. The coalition's aim was to oversee a long-term sustainable approach to preventing obesity. Following a planning phase, a business plan was developed that prioritized best practices to be implemented in Omaha.MethodsThe business plan was developed using the Ecological Model, Health Policy Model, and Robert Wood Johnson Foundation Active Living by Design 5P model. The three models helped the community identify target populations and activities that then created a single model for sustainable change.ResultsTwenty-four initiatives were identified, over one million dollars in funding was secured, and evaluation strategies were identified.ConclusionBy using the models from the initial steps through evaluation, a clear facilitation of the process was possible, and the result was a comprehensive, feasible plan. The use of the models to design a strategic plan was pivotal in building a sustainable coalition to achieve measurable improvements in the health of children and prove replicable over time.     

Invasion and Intracellular Development of the Human Granulocytic Ehrlichiosis Agent in Tick Cell Culture

Human granulocytotropic ehrlichias are tick-borne bacterial pathogens that cause an acute, life-threatening illness, human granulocytic ehrlichiosis (HGE). Ehrlichias within neutrophil granulocytes that invade tick bite sites are likely ingested by the vector, to be transmitted to another mammalian host during the tick's next blood meal. Thus, the cycle of replication and development in the vector is prerequisite to mammalian infection, and yet these events have not been described. We report tick cell culture isolation of two strains of the HGE agent directly from an infected horse and a dog and have also established a human isolate from HL60 culture in tick cells, proving that the blood stages of the HGE agent are infectious for tick cells, as are those replicating in the human cell line HL60. This required changes to the culture system, including a new tick cell line. In tick cell layers, the HGE agent induced foci of infection that caused necrotic plaques and eventual destruction of the culture. Using the human isolate and electron microscopy, we monitored adhesion, internalization, and replication in vector tick cells. Both electron-lucent and -dense forms adhered to and entered cells by a mechanism reminiscent of phagocytosis. Ehrlichial cell division was initiated soon after, resulting in endosomes filled with numerous ehrlichias. During early development, pale ehrlichias with a tight cell wall dominated, but by day 2, individual bacteria condensed into dark forms with a rippled membrane. These may become compacted into clumps where individual organisms are barely discernible. Whether these are part of an ehrlichia life cycle or are degenerating is unknown.     

Longitudinal relationship of asymptomatic hypoglycemia to cognitive function in IDDM

Early-onset insulin-dependent diabetes mellitus (IDDM) is linked to subsequent learning deficits. To investigate the relationship of learning deficits to metabolic control, 23 children with IDDM (age at testing 71 +/- 21 mo, age at diagnosis 35 +/- 15 mo) diagnosed before 5 yr of age were followed for periods of 6-78 mo. Mean glycosylated hemoglobin (HbA1), episodes of severe hypoglycemia, and frequency of self-monitoring blood glucose (SMBG) measurements less than 2.8 mM (50 mg/dl, asymptomatic hypoglycemia) were recorded every 3 mo. Six subjects entered the study 12.3 +/- 6.7 mo after diagnosis, and only severe hypoglycemia was present before entry. For the remaining 17 subjects, HbA1 and severe and asymptomatic hypoglycemia were present from the time of diagnosis of diabetes. Mean HbA1 level was 10.1 +/- 1.0%, and mean severe hypoglycemic episodes per patient was 2.9, but the frequency was highly skewed; one patient had 37 episodes, and 14 had none. The mean percentage of SMBG readings less than 2.8 mM was 2.4 +/- 2.1. On the revised Stanford-Binet Intelligence Scale there was no correlation between any subscale and severe hypoglycemia. However, the relative frequency of asymptomatic hypoglycemia correlated with scores on the abstract/visual reasoning scale (r = -.39, P = .037). This relationship was primarily accounted for by the relationship of asymptomatic hypoglycemia to performance on the copying subscale (r = -.42, P = .022). Children with frequent asymptomatic hypoglycemic episodes had lower mean copying scores and abstract reasoning scores than those with infrequent episodes.(ABSTRACT TRUNCATED AT 250 WORDS)     

Effect of liposome composition and other factors on the targeting of liposomes to experimental tumors: biodistribution and imaging studies.

We have examined the distribution of radiolabeled liposomes in tumor-bearing mice after i.v. injection. Two mouse tumors (B16 melanoma, J6456 lymphoma) and a human tumor (LS174T colon carcinoma) inoculated i.m., s.c., or in the hind footpad were used in these studies. When various liposome compositions with a mean vesicle diameter of approximately 100 nm were compared using a radiolabel of gallium-67-deferoxamine, optimal tumor localization was obtained with liposomes containing a phosphatidylcholine of high phase-transition temperature and a small molar fraction of monosialoganglioside or hydrogenated phosphatidylinositol (HPI). At 24 h after injection, average values of tumor uptake higher than 10% of the injected dose per g and liver-to-tumor ratios close to 1 were reproducibly obtained. Increasing the molar fraction of HPI from 9% to 41% of the total phospholipid resulted in enhancement of liver uptake and decrease of tumor uptake. Methodological aspects that influence vesicle size appear to affect significantly liposome localization in the tumor. However, varying the phospholipid dose within a 10-fold range caused only minor changes in the percent of injected dose recovered in the tumor. A high uptake by tumors was also observed using other radiolabels [[3H]inulin and indium-111-labeled bleomycin (111In-Bleo)] in monosialoganglioside- and HPI-containing liposomes. In the case of 111In-Bleo, encapsulation in liposomes resulted in approximately 20- to 40-fold increase in tumor accumulation of the radiolabel at 24 h after injection. The marked localization of liposomes in the mouse footpad inoculated with tumor as opposed to the contralateral mock-injected footpad was also documented by imaging experiments with gallium-67-deferoxamine and 111In-Bleo-labeled liposomes. These results support the contention that some glycolipid-containing liposomes previously shown to have long circulating half-lives accumulate significantly in a variety of tumors and are promising tools for the delivery of anti-tumor agents.