Individual-Level and Community-Level Predictors of Healthy Pregnancy Outcomes in Multigravid Black Women.

OBJECTIVE: To identify individual- and community-level factors that predict the odds of multigravid Black women having consecutive pregnancies without adverse pregnancy outcomes. METHODS: We conducted a secondary analysis of 515 multigravid Black women from a longitudinal observational study (2017-2019). We assessed the presence of adverse pregnancy outcomes (hypertensive disorders, gestational diabetes, preterm birth, fetal growth restriction, placental abruption, and pregnancy loss) for the index and prior pregnancies. We examined U.S. Census data, medical records, and surveys across multiple socioecologic domains: personal, behavioral, socioeconomic, and policy. We estimated adjusted odds ratios (aORs) and 95% CIs for the association between individual- and community-level factors and consecutive healthy pregnancies using hierarchical logistic regression models adjusted for maternal age, body mass index (BMI), gravidity, interpregnancy interval, and median household income. RESULTS: Among 515 multigravid Black women (age 27±5 years, BMI 31.4±8.9, gravidity 4±2), 38.4% had consecutive healthy pregnancies without adverse pregnancy outcomes. Individual-level factors associated with consecutive healthy pregnancies included normal glucose tolerance (aOR 3.9, 95% CI, 1.2-12.1); employment (aOR 1.9, 95% CI, 1.2-2.9); living in communities with favorable health indicators for diabetes, hypertension, and physical activity; and household income of $50,000 per year or more (aOR 3.5, 95% CI, 1.4-8.7). When individual and community factors were modeled together, only income and employment at the individual and community levels remained significant. CONCLUSION: Individual and community income and employment are associated with consecutive healthy pregnancies in a cohort of Black patients, emphasizing the need for comprehensive, multilevel systems interventions to reduce adverse pregnancy outcomes for Black women.

Two-site microendoscopic imaging probe for simultaneous three-dimensional imaging at two anatomic locations in tissues.

Systems that can image in three dimensions at cellular resolution and across different locations within an organism may enable insights into complex biological processes, such as immune responses, for which a single location measurement may be insufficient. In this Letter, we describe an in vivo two-site imaging probe (TIP) that can simultaneously image two anatomic sites with a maximum separation of a few centimeters. The TIP consists of two identical bendable graded index (GRIN) lenses and is demonstrated by a two-photon two-color fluorescence imaging system. Each GRIN lens has a field of view of 162 × 162 × 170 µm3, a nominal numerical aperture of 0.5, a magnification of 0.7, and working distances of 0.2 mm in air for both ends. A blind linear unmixing algorithm is applied to suppress bleedthrough between channels. We use this system to successfully demonstrate two-site two-photon two-color imaging of two biomedically relevant samples, i.e., (1) a mixture of two autofluorescent anti-cancer drugs and (2) a live hybrid tumor consisting of two spectrally distinct fluorescent cell lines.

Detection of a major Lynch Syndrome-causing MLH1 founder variant in a large-scale genotyped cohort.

Some 50% of Finnish Lynch Syndrome (LS) cases are caused by a founder variant in MLH1, in which the entire exon 16 has been lost due to an Alu-mediated recombination event. We piloted detecting the variant in FinnGen, a large genotyped cohort comprising approximately 10% of the current Finnish population, and validated the MLH1 founder variant status of identified individuals residing in the Central Finland Biobank catchment area. A consensus sequence flanking the deletion was identified in whole genome sequences of six LS individuals with the founder variant. Genotype data of 212,196 individuals was queried for regional matches to the consensus sequence. Enrichment of cancer and age at cancer onset was compared between matching and non-matching individuals. Variant status was validated for a subset of the identified individuals using a polymerase chain reaction assay. Allelic matches in a chosen target region was detected in 348 individuals, with 89 having a cancer diagnosis (Bonferroni-adjusted p-value = 1), 20 a familial cancer history (p-adj. < .001), with mean age of onset of cancer being 53.6 years (p-adj. = .002). Eighteen of potential variant carriers had been sampled by the Central Finland Biobank, of which four (22%) were validated as true variant carriers. The workflow we have employed identifies MLH1 exon 16 deletion variant carriers from population-wide SNP genotyping data. An alternative design will be sought to limit false positive findings. Large genotyped cohorts provide a potential resource for identification and prevention of hereditary cancer.

Individual-Level and Community-Level Predictors of Healthy Pregnancy Outcomes in Multigravid Black Women.

OBJECTIVE: To identify individual- and community-level factors that predict the odds of multigravid Black women having consecutive pregnancies without adverse pregnancy outcomes. METHODS: We conducted a secondary analysis of 515 multigravid Black women from a longitudinal observational study (2017-2019). We assessed the presence of adverse pregnancy outcomes (hypertensive disorders, gestational diabetes, preterm birth, fetal growth restriction, placental abruption, and pregnancy loss) for the index and prior pregnancies. We examined U.S. Census data, medical records, and surveys across multiple socioecologic domains: personal, behavioral, socioeconomic, and policy. We estimated adjusted odds ratios (aORs) and 95% CIs for the association between individual- and community-level factors and consecutive healthy pregnancies using hierarchical logistic regression models adjusted for maternal age, body mass index (BMI), gravidity, interpregnancy interval, and median household income. RESULTS: Among 515 multigravid Black women (age 27±5 years, BMI 31.4±8.9, gravidity 4±2), 38.4% had consecutive healthy pregnancies without adverse pregnancy outcomes. Individual-level factors associated with consecutive healthy pregnancies included normal glucose tolerance (aOR 3.9, 95% CI, 1.2-12.1); employment (aOR 1.9, 95% CI, 1.2-2.9); living in communities with favorable health indicators for diabetes, hypertension, and physical activity; and household income of $50,000 per year or more (aOR 3.5, 95% CI, 1.4-8.7). When individual and community factors were modeled together, only income and employment at the individual and community levels remained significant. CONCLUSION: Individual and community income and employment are associated with consecutive healthy pregnancies in a cohort of Black patients, emphasizing the need for comprehensive, multilevel systems interventions to reduce adverse pregnancy outcomes for Black women.

Novelty preference assessed by eye tracking: A sensitive measure of impaired recognition memory in epilepsy.

OBJECTIVE: Epilepsy patients often report memory deficits despite normal objective testing, suggesting that available measures are insensitive or that non-mnemonic factors are involved. The Visual Paired Comparison Task (VPCT) assesses novelty preference, the tendency to fixate on novel images rather than previously viewed items, requiring recognition memory for the "old" images. As novelty preference is a sensitive measure of hippocampal-dependent memory function, we predicted impaired VPCT performance in epilepsy patients compared to healthy controls. METHODS: We assessed 26 healthy adult controls and 31 epilepsy patients (16 focal-onset, 13 generalized-onset, 2 unknown-onset) with the VPCT using delays of 2 or 30 s between encoding and recognition. Fifteen healthy controls and 17 epilepsy patients (10 focal-onset, 5 generalized-onset, 2 unknown-onset) completed the task at 2-, 5-, and 30-minute delays. Subjects also performed standard memory measures, including the Medical College of Georgia (MCG) Paragraph Test, California Verbal Learning Test-Second Edition (CVLT-II), and Brief Visual Memory Test-Revised (BVMT-R). RESULTS: The epilepsy group was high functioning, with greater estimated IQ (p = 0.041), greater years of education (p = 0.034), and higher BVMT-R scores (p = 0.024) compared to controls. Both the control group and epilepsy cohort, as well as focal- and generalized-onset subgroups, had intact novelty preference at the 2- and 30-second delays (p-values ≤ 0.001) and declined at 30 min (p-values > 0.05). Only the epilepsy patients had early declines at 2- and 5-minute delays (controls with intact novelty preference at p = 0.003 and p ≤ 0.001, respectively; epilepsy groups' p-values > 0.05). CONCLUSIONS: Memory for the "old" items decayed more rapidly in overall, focal-onset, and generalized-onset epilepsy groups. The VPCT detected deficits while standard memory measures were largely intact, suggesting that the VPCT may be a more sensitive measure of temporal lobe memory function than standard neuropsychological batteries.

Tracking activity-based therapy for people living with spinal cord injury or disease: insights gained through focus group interviews with key stakeholders.

PURPOSE: The development of a tool to track participation in activity-based therapy (ABT) for people with spinal cord injury or disease (SCI/D) was identified as a priority of the Canadian ABT Community of Practice. The objective of this study was to understand multi-stakeholder perspectives on tracking ABT participation across the continuum of care. MATERIALS AND METHODS: Forty-eight individuals from six stakeholder groups (persons living with SCI/D; hospital therapists; community trainers; administrators; researchers; and funders, advocates and policy experts) were recruited to participate in focus group interviews. Participants were asked open-ended questions concerning the importance of and parameters around tracking ABT. Transcripts were analyzed using conventional content analysis. RESULTS: Themes reflected the Who, What, Where, When, Why and How of tracking ABT. Participants described the importance of involving hospital therapists, community trainers and individuals with SCI/D in tracking ABT to capture both subjective and objective parameters across the continuum of care and injury trajectory. Digital tracking tools were favoured, although paper-based versions were regarded as a necessity in some circumstances. CONCLUSIONS: Findings highlighted the importance of tracking ABT participation for individuals with SCI/D. The information may guide the development of ABT practice guidelines and support the implementation of ABT in Canada.

Tracking the details of activity-based therapy (ABT) sessions and programs across the continuum of care and injury trajectory may provide important information to support the development of ABT practice guidelines and implementation strategies.Tracking objective and subjective parameters are needed to provide a comprehensive description of an ABT session and program.Clinicians and individuals with spinal cord injury or disease (SCI/D) should both be able to track ABT to accommodate all settings and types of data.Digital tracking tools, such as an app, may provide an accessible, versatile and efficient way of tracking ABT.

Associations Between Estimates of Arterial Stiffness and Cognitive Functioning in Adults With HIV.

BACKGROUND: Vascular aging, a precursor of arterial stiffness, is associated with neurocognitive impairment (NCI) and cardiovascular disease. Although HIV is associated with rapid vascular aging, it is unknown whether arterial stiffness mediates changes in cognitive function. We explored whether estimated markers of vascular aging were associated with NCI indices in HIV-positive individuals. METHODS: This study was a secondary analysis of an observational study. Neurocognitive functioning was assessed using a battery of 7 domains (verbal fluency, executive functioning, speed of information processing, attention/working memory, memory [learning and delayed recall], and motor skills). Vascular aging was assessed using estimated markers of arterial stiffness (ie, estimated pulse wave velocity, pulse pressure, and vascular overload index). A multivariable regression adjusted for demographics, cardiovascular disease risk factors, and HIV clinical variables was used to examine the association between vascular aging and NCI outcomes. RESULTS: Among 165 people with HIV, the mean age was 51.5 ± 6.9 years (62% men and 83% African American/Black or Other). In fully adjusted models, an increase in estimated pulse wave velocity and pulse pressure was associated with lower T scores in learning (-2.95 [-5.13, -0.77]) and working memory (-2.37 [-4.36, -0.37]), respectively. An increase in vascular overload index was associated with lower T scores in working memory (-2.33 [-4.37, -0.29]) and learning (-1.85 [-3.49, -0.21]). CONCLUSIONS: Estimated markers of arterial stiffness were weakly associated with neurocognitive functioning, suggesting that vascular aging may have a role in cognitive decline among people with HIV.

Leptin resistance in children with in utero exposure to maternal obesity and gestational diabetes.

BACKGROUND: Leptin resistance occurs with obesity, but it is unknown if individuals at risk for obesity develop leptin resistance prior to obesity. OBJECTIVE: Investigate whether leptin resistance is independent of weight status in children at risk for obesity due to intrauterine exposure to maternal obesity or gestational diabetes mellitus (GDM). METHODS: Mother-child dyads (N = 179) were grouped by maternal pregnancy weight and GDM status: (1) normal weight, no GDM; (2) overweight/obesity, no GDM; (3) overweight/obesity with GDM. Children (4-10 years) were further stratified by current body mass index (BMI) <85th or ≥85th percentile. Leptin resistance of children and mothers was calculated as fasting leptin/fat mass index. Two-way ANOVA was used to assess whether leptin concentrations and leptin resistance differed by current weight status or in utero exposure group, after adjusting for race, sex and Tanner stage. RESULTS: Children with a BMI ≥85th percentile had more leptin resistance than those with a BMI <85th percentile (p < 0.001), but leptin resistance did not differ by in utero exposure. Similarly, leptin resistance in women was associated with weight status and not prior GDM. CONCLUSIONS: Results suggest that leptin concentrations are associated with obesity but not risk for obesity based on in utero exposure to maternal obesity or GDM.

The experience of falls and fall risk during the subacute phase of spinal cord injury: a mixed methods study.

Purpose: To understand the circumstances, causes and consequences of falls experienced by individuals with subacute SCI, and to explore their perspectives on how falls/fall risk impacted their transition to community living.Materials and methods: Sixty adults with subacute SCI participated. A sequential explanatory mixed methods design was adopted. In Phase I, falls were monitored for six months post-inpatient rehabilitation discharge through a survey. In Phase II, a qualitative focus group (n = 5) was held to discuss participants' perspectives on Phase I results and falls/fall risk. Descriptive statistics and thematic analysis were used to analyze Phase I and II data, respectively.Results: Falls commonly occurred in the daytime, at home and about half resulted in minor injury. Three themes reflecting participants' perspectives were identified in Phase II. 1) Lack of preparedness to manage fall risk upon returning home from inpatient rehabilitation. 2) Adjusting to increased fall risk following discharge from inpatient rehabilitation. 3) Psychological impact of the transition to living at home with an increased fall risk.Conclusions: The findings highlight the need for fall prevention initiatives during subacute SCI, when individuals are learning to manage their increased fall risk.

Falls are common in the subacute phase of spinal cord injury (SCI), with falls commonly occurring in the daytime at home while walking or changing positions and resulting in minor injury.Individuals living with SCI feel unprepared to manage the increased fall risk experienced after discharge from inpatient rehabilitation, and the possibility of falling can cause anxiety and fear.Following the transition from inpatient rehabilitation to living at home, individuals with SCI would like continued support from health professionals and/or peers to prevent falls and adjust to living independently with SCI.

Developing evidence-based patient-focused learning materials to support health behaviour change for people living with psoriatic arthritis.

OBJECTIVES: In psoriatic arthritis (PsA), self-management is important for patient function and quality of life. Behaviour change can be difficult, patients could benefit from high-quality support to initiate change. Our aim was to codesign the project as theory-informed, evidence-based, patient-focused, materials supporting healthy lifestyle changes for patients diagnosed with PsA. METHODS: Development of the materials was overseen by a steering group of patients with PsA, psychologists, rheumatologists, a design team and researchers. First, a literature review was performed to establish the evidence base for behaviours and potential interventions in PsA, including diet, weight, alcohol, smoking, exercise, anxiety, depression and stress. An initial roundtable of patients with PsA prioritised areas and content ideas. Draft materials including a website and downloadable materials were produced. A second roundtable of patients with PsA collected feedback on the draft content and design. A third roundtable was held with patients with PsA and a fourth with clinicians to refine the materials and ensuring that they were evidence based, accessible, interesting, and helpful to initiate and maintain change. A final evaluation survey was performed to review the draft website before launching the final materials. RESULTS: 15 candidate topics were prioritised. A website and set of postcards summarising the topics were developed by the design team and refined following feedback from the roundtable groups. CONCLUSION: This project created patient-focused resources to support behaviour change. It addresses common concerns of patients with PsA about how they may optimise their health by providing practical and brief interventions to challenge and support them to make changes.

Genetic variants in melanogenesis proteins TYRP1 and TYR are associated with the golden rhesus macaque phenotype.

Nonhuman primates (NHPs) are vital translational research models due to their high genetic, physiological, and anatomical homology with humans. The "golden" rhesus macaque (Macaca mulatta) phenotype is a naturally occurring, inherited trait with a visually distinct pigmentation pattern resulting in light blonde colored fur. Retinal imaging also reveals consistent hypopigmentation and occasional foveal hypoplasia. Here, we describe the use of genome-wide association in 2 distinct NHP populations to identify candidate variants in genes linked to the golden phenotype. Two missense variants were identified in the Tyrosinase-related protein 1 gene (Asp343Gly and Leu415Pro) that segregate with the phenotype. An additional and distinct association was also found with a Tyrosinase variant (His256Gln), indicating the light-colored fur phenotype can result from multiple genetic mechanisms. The implicated genes are related through their contribution to the melanogenesis pathway. Variants in these 2 genes are known to cause pigmentation phenotypes in other species and to be associated with oculocutaneous albinism in humans. The novel associations presented in this study will permit further investigations into the role these proteins and variants play in the melanogenesis pathway and model the effects of genetic hypopigmentation and altered melanogenesis in a naturally occurring nonhuman primate model.

Humoral profiling of pediatric patients with cancer reveals robust immunity following anti-SARS-CoV-2 vaccination superior to natural infection.

BACKGROUND: Pediatric patients with cancer infected with COVID-19 may be at higher risk of severe disease and may be unable to mount an adequate response to the virus due to compromised immunity secondary to their cancer therapy. PROCEDURE: This study presents immunologic analyses of 20 pediatric patients with cancer, on active chemotherapy or having previously received chemotherapy, and measures their immunoglobulin titers and activation of cellular immunity response to acute SARS-CoV-2 infection and COVID-19 vaccination compared with healthy pediatric controls. RESULTS: Forty-three patients were enrolled, of which 10 were actively receiving chemotherapy, 10 had previously received chemotherapy, and 23 were healthy controls. Pediatric patients with cancer had similar immunoglobulin titers, antibody binding capacity, and effector function assay activity after vaccination against COVID-19 compared with healthy controls, though more variability in response was noted in the cohort actively receiving chemotherapy. Compared with acute infection, vaccination against COVID-19 produced superior immunoglobulin responses, particularly IgA1, IgG1, and IgG3, and elicited superior binding capacity and effector function in children with cancer and healthy controls. CONCLUSIONS: Pediatric patients receiving chemotherapy and those who had previously received chemotherapy had adequate immune activation after both vaccination and acute infection compared to healthy pediatric controls, although there was a demonstrated variability in response for the patients on active chemotherapy. Vaccination against COVID-19 produced superior immune responses compared to acute SARS-CoV-2 infection in pediatric patients with cancer and healthy children, underscoring the importance of vaccination even in previously infected individuals.

Clinical Features and Risk Factors Associated With Multisystem Inflammatory Syndrome in Children With Cancer and COVID-19.

Importance: Little is known about the risk of post-COVID-19 multisystem inflammatory syndrome in children (MIS-C) in the setting of childhood cancer. Objective: To evaluate factors associated with MIS-C and describe the clinical course of COVID-19 in the setting of MIS-C. Design, Setting, and Participants: Multisite observational cohort study of a registry representing more than 100 US pediatric oncology sites. All included patients were registered between April 1, 2020, and May 18, 2022. Sites submitted deidentified data surrounding sociodemographics, cancer diagnosis and treatment, and COVID-19 course (symptoms, maximum support required, outcome). Patients with MIS-C (n = 24) were compared with matched controls (n = 96). Children (<21 years) with cancer who developed COVID-19 while receiving cancer treatment or within 1 year of completing treatment were characterized based on their development of MIS-C. Exposures: (1) Clinical and sociodemographic characteristics of children with cancer and COVID-19; and (2) MIS-C. Main Outcomes and Measures: (1) Development of MIS-C among children with cancer and COVID-19; and (2) symptoms and disease severity associated with MIS-C. Results: Among 2035 children with cancer and COVID-19, 24 (1.2%) developed MIS-C. COVID-19 occurred at a median (IQR) age of 12.5 (5.5-17.1) years in those with MIS-C and 11 (6-16) years among matched controls (P = .86). The majority of children with MIS-C had a hematologic cancer (83.3% [n = 20]), were publicly insured (66.7% [n = 16]), and were Hispanic (54.2% [n = 13]). Half (n = 12) had 1 or more noncancer comorbidity. Those with comorbidities were more likely to develop MIS-C than those without (odds ratio [OR], 2.5 [95% CI, 1.1-5.7]). Among children with MIS-C, 100% (n = 24) were admitted to the hospital and 54.2% (n = 13) to the intensive care unit (ICU), while COVID-19 contributed to the death of 20.1% (n = 5); cancer therapy was changed in 62.5% (n = 15). Compared with matched controls, those with MIS-C had higher odds of symptoms classified as systemic (OR, 4.7 [95% CI, 1.4-15.8]) or gastrointestinal (OR, 5.0 [95% CI, 1.7-14.6]) along with higher odds of hospitalization (OR, 42.9 [95% CI, 7.1-258]), ICU admission (OR, 11.4 [95% CI, 3.6-36.4]), and changes to cancer therapy (OR, 24.9 [95% CI, 6.5-94.8]). Conclusions and Relevance: In this cohort study among children with cancer and COVID-19, those with MIS-C had a more severe clinical course than those without MIS-C. The risk of MIS-C and its severity are important to consider as clinicians monitor patients with COVID-19. These findings can inform their conversations with families regarding COVID-19 risks and the benefits of prevention strategies that are pharmacologic (vaccination) and nonpharmacologic (masking), as well as treatment (antivirals, monoclonal antibodies).

Increasing diversity, equity, and inclusion in the fields of nutrition and obesity: A roadmap to equity in academia.

Research shows that a diverse faculty improves academic, clinical, and research outcomes in higher education. Despite that, persons in minority groups, usually categorized by race or ethnicity, are underrepresented in academia (URiA). The Nutrition Obesity Research Centers (NORCs), supported by the NIDDK, hosted workshops on five separate days in September and October 2020. NORCs convened these workshops to identify barriers and facilitators for diversity, equity, and inclusion (DEI) and provide specific recommendations to improve DEI within obesity and nutrition for individuals from URiA groups. Recognized experts on DEI presented each day, after which the NORCs conducted breakout sessions with key stakeholders who engage in nutrition and obesity research. The breakout session groups included early-career investigators, professional societies, and academic leadership. The consensus from the breakout sessions was that glaring inequities affect URiA in nutrition and obesity, particularly related to recruitment, retention, and advancement. Recommendations from the breakout sessions to improve DEI across the academe focused on six themes: (1) recruitment, (2) retention, (3) advancement, (4) intersectionality of multiple challenges (e.g., being Black and a woman), (5) funding agencies, and (6) implementation of strategies to address problems related to DEI.

Increasing diversity, equity, and inclusion in the fields of nutrition and obesity: A road map to equity in academia.

Research shows that a diverse faculty improves academic, clinical, and research outcomes in higher education. Despite that, persons in minority groups, usually categorized by race or ethnicity, are underrepresented in academia (URiA). The Nutrition Obesity Research Centers (NORCs), supported by the National Institute of Diabetes and Digestive and Kidney Diseases, hosted workshops on five separate days in September and October 2020. NORCs convened these workshops to identify barriers and facilitators for diversity, equity, and inclusion (DEI) and provide specific recommendations to improve DEI within obesity and nutrition for individuals from URiA groups. Recognized experts on DEI presented each day, after which the NORCs conducted breakout sessions with key stakeholders who engage in nutrition and obesity research. The breakout session groups included early-career investigators, professional societies, and academic leadership. The consensus from the breakout sessions was that glaring inequities affect URiA in nutrition and obesity, particularly related to recruitment, retention, and advancement. Recommendations from the breakout sessions to improve DEI across academia focused on six themes: (1) recruitment, (2) retention, (3) advancement, (4) intersectionality of multiple challenges (e.g., being Black and a woman), (5) funding agencies, and (6) implementation of strategies to address problems related to DEI.

Outcomes of shared institutional review board compared with multiple individual site institutional review board models in a multisite clinical trial.

BACKGROUND: Institutional review boards play a crucial role in initiating clinical trials. Although many multicenter clinical trials use an individual institutional review board model, where each institution uses their local institutional review board, it is unknown if a shared (single institutional review board) model would reduce the time required to approve a standard institutional review board protocol. OBJECTIVE: This study aimed to compare processing times and other processing characteristics between sites using a single institutional review board model and those using their individual site institutional review board model in a multicenter clinical trial. STUDY DESIGN: This was a retrospective study of sites in an open-label, multicenter randomized control trial from 2014 to 2021. Participating sites in the multicenter Chronic Hypertension and Pregnancy trial were asked to complete a survey collecting data describing their institutional review board approval process. RESULTS: A total of 45 sites participated in the survey (7 used a shared institutional review board model and 38 used their individual institutional review board model). Most sites (86%) using the shared institutional review board model did not require a full-board institutional review board meeting before protocol approval, compared with 1 site (3%) using the individual institutional review board model (P<.001). Median total approval times (41 vs 56 days; P=.42), numbers of submission rounds (1 vs 2; P=.09), and numbers of institutional review board stipulations (1 vs 4; P=.12) were lower for the group using the shared institutional review board model than those using the individual site institutional review board model; however, these differences were not statistically significant. CONCLUSION: The findings supported the hypothesis that the shared institutional review board model for multicenter studies may be more efficient in terms of cumulative time and effort required to obtain approval of an institutional review board protocol than the individual institutional review board model. Given that these data have important implications for multicenter clinical trials, future research should evaluate these findings using larger or multiple multicenter trials.

Associations Among Physical Activity, Adiposity, and Insulin Resistance in Children Exposed In Utero to Maternal Obesity With and Without Gestational Diabetes.

PURPOSE: Investigate whether obesity risk and current weight status are independently associated with physical activity (PA) and whether PA is associated with adiposity and insulin resistance (homeostatic model assessment of insulin resistance) among children with high versus low obesity risk based on in utero exposure to maternal overweight/obesity with gestational diabetes mellitus (GDM; high risk) or without GDM (overweight/obesity; high risk) or maternal normal weight without GDM (low risk). METHOD: Secondary analysis of data from children born to women with overweight/obesity and GDM, overweight/obesity without GDM, or normal weight without GDM. PA was assessed with accelerometry, percentage of body fat derived from anthropometrics, and homeostatic model assessment of insulin resistance calculated from glucose and insulin. RESULTS: Among 4- to 10-year-old children (N = 163), analyses of covariance showed that children with a current BMI ≥85th percentile had less vigorous PA than those with BMI <85th percentile, but in utero exposure was not an independent predictor of PA. In linear regression modeling, moderate to vigorous PA was inversely associated with percentage of body fat and homeostatic model assessment of insulin resistance independent of age, Tanner stage, and accelerometer wear time, with stronger associations in high-risk groups. CONCLUSIONS: Children's PA is related to current weight status but not underlying risk for obesity but may be especially important to reduce obesity and insulin resistance in high-risk children.