Dual versus single long-acting bronchodilator use could raise acute coronary syndrome risk by over 50%: A population-based nested case-control study.

BACKGROUND: Coronary heart disease occurs more frequently among patients with chronic obstructive pulmonary disease (COPD) compared to those without COPD. While some research suggests that long-acting bronchodilators might confer an additional risk of acute coronary syndrome (ACS), information from real-world clinical practice about the cardiovascular impact of using two versus one long-acting bronchodilator for COPD is limited. We undertook a population-based nested case-control study to estimate the risk of ACS in users of both a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-agonist (LABA) relative to users of a LAMA. METHODS: The study was based on the primary care PREDICT Cardiovascular Disease Cohort and linked data from regional laboratories and the New Zealand Ministry of Health's national data collections. The underlying cohort (n = 29,993) comprised patients aged 45-84 years, who initiated treatment with a LAMA and/or LABA for COPD between 1 February 2006 and 11 October 2016. 1490 ACS cases were matched to 13,550 controls by date of birth, sex, date of cohort entry (first long-acting bronchodilator dispensing), and COPD severity. RESULTS: Relative to current use of LAMA therapy, current use of LAMA and LABA dual therapy was associated with a significantly higher risk of ACS (adjusted OR = 1.72; [95% CI: 1.28-2.31]). CONCLUSION: Dual long-acting bronchodilator therapy, rather than LAMA mono-therapy, could increase the risk of ACS by more than 50%. This has important implications for decisions about the potential benefit/harm ratio of COPD treatment intensification, given the modest benefits of dual therapy.

Is the use of two versus one long-acting bronchodilator by patients with COPD associated with a higher risk of acute coronary syndrome in real-world clinical practice?

BACKGROUND: Cardiovascular comorbidity is common among patients with chronic obstructive pulmonary disease (COPD) and there is concern that long-acting bronchodilators (long-acting muscarinic antagonists (LAMAs) and long-acting beta2 agonists (LABAs)) may further increase the risk of acute coronary events. Information about the impact of treatment intensification on acute coronary syndrome (ACS) risk in real-world settings is limited. We undertook a nationwide nested case-control study to estimate the risk of ACS in users of both a LAMA and a LABA relative to users of a LAMA. METHODS: We used routinely collected national health and pharmaceutical dispensing data to establish a cohort of patients aged >45 years who initiated long-acting bronchodilator therapy for COPD between 1 February 2006 and 30 December 2013. Fatal and non-fatal ACS events during follow-up were identified using hospital discharge and mortality records. For each case we used risk set sampling to randomly select up to 10 controls, matched by date of birth, sex, date of cohort entry (first LAMA and/or LABA dispensing), and COPD severity. RESULTS: From the cohort (n=83 417), we identified 5399 ACS cases during 281 292 person-years of follow-up. Compared with current use of LAMA therapy, current use of LAMA and LABA dual therapy was associated with a higher risk of ACS (OR 1.28 (95% CI 1.13 to 1.44)). The OR in an analysis restricted to fatal cases was 1.46 (95% CI 1.12 to 1.91). CONCLUSION: In real-world clinical practice, use of two versus one long-acting bronchodilator by people with COPD is associated with a higher risk of ACS.

Characteristics of Adults With Hepatitis C Virus: Evidence From the National Health and Nutrition Examination Survey 2011-2012.

Hepatitis C virus (HCV) infects more than 3 million people in the United States (U.S.). Long-term complications of hepatitis C infection result in increased liver disease and financial burden for the nation. The purpose of this study was to identify characteristics of adults with HCV in the U.S. This secondary, descriptive study analyzed data from the 2011-2012 National Health and Nutrition Examination Survey. The weighted sample included 2,075,749 adults diagnosed with HCV. Descriptive statistics were calculated. The findings revealed that most adults in the U.S. with HCV were insured non-Hispanic, white males, aged 45 to 64 years. Almost half of adults with HCV denied a liver condition. Several participants either were co-infected or had previous infection (82%) with other hepatitis. Substance use (53.5%), alcohol use (96%), and cigarette use (88.6%) among adults with HCV were higher than previously reported. A majority of adults were noncompliant with hepatitis A and B vaccination series completion (67% and 65.1%, respectively). Medication adherence was higher than other reported cases. Adults with HCV have increased mental health symptoms (67.1%) and do not routinely visit a mental health professional (90.2%). HCV-infected adults are likely to use alcohol, cigarettes, and/or other substances. Adults with HCV have significant mental health issues, but rarely access care. Medication adherence was higher than expected for this cohort. The findings provide information for nurses to develop individualized plans of care and identify at-risk individuals for treatment noncompliance.

Quantity versus quality of objectively measured sleep in relation to body mass index in children: cross-sectional and longitudinal analyses.

BACKGROUND/OBJECTIVES: Although sleep duration is well established as a risk factor for child obesity, how measures of sleep quality relate to body size is less certain. The aim of this study was to determine how objectively measured sleep duration, sleep timing, and sleep quality were related to body mass index (BMI) cross-sectionally and longitudinally in school-aged children. SUBJECTS/METHODS: All measures were obtained at baseline, 12 and 24 months in 823 children (51% female, 53% European, 18% Maori, 12% Pacific, 9% Asian) aged 6-10 years at baseline. Sleep duration, timing, and quality were measured using actigraphy over 7 days, height and weight were measured using standard techniques, and parents completed questionnaires on demographics (baseline only), dietary intake, and television usage. Data were analysed using imputation; mixed models, with random effects for person and age, estimated both a cross-sectional effect and a longitudinal effect on BMI z-score, adjusted for multiple confounders. RESULTS: The estimate of the effect on BMI z-score for each additional hour of sleep was -0.22 (95% CI: -0.33, -0.11) in cross-sectional analyses and -0.05 (-0.10, -0.004) in longitudinal analyses. A greater effect was observed for weekday sleep duration than weekend sleep duration but variability in duration was not related to BMI z-score. While sleep timing (onset or midpoint of sleep) was not related to BMI, children who were awake in the night more frequently (0.19; 0.06, 0.32) or for longer periods (0.18; 0.06, 0.36) had significantly higher BMI z-scores cross-sectionally, but only the estimates for total time awake (minutes) were significant longitudinally (increase in BMI z-score of 0.04 for each additional hour awake). CONCLUSION: The beneficial effect of a longer sleep duration on BMI was consistent in children, whereas evidence for markers of sleep quality and timing were more variable.

Quantitative classification of vortical flows based on topological features using graph matching.

Vortical flow patterns generated by swimming animals or flow separation (e.g. behind bluff objects such as cylinders) provide important insight to global flow behaviour such as fluid dynamic drag or propulsive performance. The present work introduces a new method for quantitatively comparing and classifying flow fields using a novel graph-theoretic concept, called a weighted Gabriel graph, that employs critical points of the velocity vector field, which identify key flow features such as vortices, as graph vertices. The edges (connections between vertices) and edge weights of the weighted Gabriel graph encode local geometric structure. The resulting graph exhibits robustness to minor changes in the flow fields. Dissimilarity between flow fields is quantified by finding the best match (minimum difference) in weights of matched graph edges under relevant constraints on the properties of the edge vertices, and flows are classified using hierarchical clustering based on computed dissimilarity. Application of this approach to a set of artificially generated, periodic vortical flows demonstrates high classification accuracy, even for large perturbations, and insensitivity to scale variations and number of periods in the periodic flow pattern. The generality of the approach allows for comparison of flows generated by very different means (e.g. different animal species).

Nursing Interventions on Medication Adherence During Hepatitis C Treatment: Application of Self-Regulation Model.

Hepatitis C virus is a common cause of liver disease nationally and globally. Medication adherence to hepatitis C treatment is important for viral eradication and the prevention of chronic disease. The purpose of this article is to identify a nursing middle-range theory to guide research on the impact of nursing interventions on medication adherence during hepatitis C treatment and to apply the theory to practice by providing examples of the theory application. A gap in the literature is identified as the lack of research using theories or models as a guide to investigate nursing interventions and hepatitis C treatment. The lack of theory-based research may contribute to medication nonadherence. The self-regulation model provides the most complete guide for nursing interventions during hepatitis C treatment. Nursing interventions and hepatitis C research, guided by theory, generate knowledge specific for nursing.

Impact of Nursing Interventions on Medication Adherence During Hepatitis C Treatment: State of the Science.

This article is a literature review to determine the state of the science regarding the impact of nursing interventions in the treatment of hepatitis C. Hepatitis C is a chronic disease impacting millions of people globally. Treatment is currently available that has the potential to cure the disease. Medication adherence is vital to the eradication of the disease. Nursing interventions could possibly assist in the improvement in medication adherence. By reviewing the literature, the factors influencing patient outcomes were identified. Four themes identified in the literature are influence of comorbidities, self-motivation, psychological factors, and provider support. The research studies are compared and contrasted within and across the themes. Identification of what is known and what is not known about nursing interventions in the treatment of hepatitis C is illustrated in the conclusion of the article. Finally, suggestions for future research are presented. Specific areas of study are identified for focus in the future research.

Predictors of breastfeeding duration in a predominantly Maori population in New Zealand.

BACKGROUND: Although breastfeeding duration in New Zealand's indigenous Maori is shorter than in non-Maori, we know little about barriers or motivators of breastfeeding in this community. The aim of this analysis was to identify predictors for extended duration of breastfeeding amongst participants drawn from predominantly Maori communities in regional Hawke's Bay. METHODS: Mother/baby dyads were recruited from two midwifery practices serving predominantly Maori women in mostly deprived areas, for a randomised controlled trial comparing the risks and benefits of an indigenous sleeping device (wahakura) and a bassinet. Questionnaires were administered at baseline (pregnancy) and at one, three and six months postnatal. Several questions relating to breastfeeding and factors associated with breastfeeding were included. The data from both groups were pooled to examine predictors of breastfeeding duration. RESULTS: Maori comprised 70.5% of the 197 participants recruited. The median time infants were fully breastfed was eight weeks and Maori women were more likely to breastfeed for a shorter duration than New Zealand European women with an odds-ratio (OR) of 0.45 (95% CI 0.24, 0.85). The key predictors for extended duration of breastfeeding were the strong support of the mother's partner (OR = 3.64, 95% CI 1.76, 7.55) or her mother for breastfeeding (OR = 2.47, 95% CI 1.27, 4.82), longer intended duration of maternal breastfeeding (OR = 1.02, 95% CI 1.00, 1.03) and being an older mother (OR = 1.07, 95% CI 1.02, 1.12). The key predictors for shorter duration of breastfeeding were pacifier use (OR = 0.28, 95% CI 0.17, 0.46), daily cigarette smoking (OR = 0.51, 95% CI 0.37, 0.69), alcohol use (OR = 0.54, 95% CI 0.31, 0.93) and living in a more deprived area (OR 0.40, 95% CI 0.22, 0.72). CONCLUSIONS: Breastfeeding duration in this group of mainly Maori women was shorter than the national average. Increasing the duration of breastfeeding by these mothers could be further facilitated by ante and postnatal education involving their own mothers and their partners in the support of breastfeeding and by addressing pacifier use, smoking and alcohol use.

Pharmaceutical interventions for weight-loss maintenance: no effect from cabergoline.

BACKGROUND: Weight regain is a major limitation to successful weight maintenance following weight loss. Observational studies suggest that stimulation of dopamine receptors in the central nervous system is associated with weight loss and inhibition of weight gain. Our objective was to test the hypothesis that dopamine agonist treatment would prevent weight regain following acute weight loss in individuals with obesity. METHODS: We conducted a 2-year double blind randomised controlled trial comparing the effect of a dopamine agonist, cabergoline, with placebo on weight regain in obese individuals who had lost at least 5% of their body weight using an 800 kcal/day commercial meal replacement programme. The primary outcome measure was the difference in mean weight between the treatment and control groups over the 2-year period following randomisation. RESULTS: At 24 months, there was no difference in body weight between cabergoline and placebo treatment after adjustment for age, gender and baseline values (0.6 kg (95% CI: -1.5, 2.6), p = 0.58). The mean (±SD) baseline body weight of the randomised participants was 101.8 kg, the mean (±SD) weight loss with the 800 kcal/day diet was 7.1 ± 1.8 kg and the mean (±SD) weight regain at 24 months was 5.1 ± 7.5 kg. There were no significant differences in BMI, percent weight loss, waist circumference, resting energy expenditure, blood pressure or metabolic parameters at 24 months between the two groups. CONCLUSIONS: Treatment with the dopamine agonist cabergoline does not prevent weight regain in obese individuals following weight loss.

Impact of a modified version of baby-led weaning on iron intake and status: a randomised controlled trial.

OBJECTIVE: To determine the iron intake and status of infants following a version of baby-led weaning (BLW) modified to prevent iron deficiency (Baby-Led Introduction to SolidS; BLISS) compared with those of infants following traditional spoon-feeding. DESIGN, PARTICIPANTS AND INTERVENTION: This randomised controlled trial included 206 participants assigned to control (n=101) or BLISS (n=105) groups. Both groups received standard midwifery and 'Well Child' care. BLISS participants received eight additional visits (from before birth to 9 months) providing education and support on the BLISS approach to complementary feeding (ie, BLW modified to increase iron intake). The primary outcome of the BLISS study (growth) has been previously reported. This paper reports the key prespecified secondary outcomes, iron intake and iron status. OUTCOME MEASURES: Intake of iron and key absorption modifiers were assessed using weighed 3-day diet records at 7 and 12 months. A venipuncture blood sample was collected at 12 months to determine plasma ferritin, haemoglobin, soluble transferrin receptor, C-reactive protein and α1-acid glycoprotein concentrations; and body iron was calculated. RESULTS: Differences in median dietary iron intakes between the control and BLISS groups were not significant at 7 (difference 0.6 mg/day; 95% CI -1.0 to 2.3) or 12 (-0.1 mg/day; -1.6 to 1.4) months of age. Similarly, there were no significant differences in plasma ferritin concentration (difference -2.6 µg/L; 95% CI -10.9 to 5.8), body iron (0.04 mg/kg; -1.1 to 1.2) or the prevalence of depleted iron stores, early functional iron deficiency or iron deficiency anaemia (all p≥0.65) at 12 months of age. CONCLUSIONS: A baby-led approach to complementary feeding does not appear to increase the risk of iron deficiency in infants when their parents are given advice to offer 'high-iron' foods with each meal. TRIAL REGISTRATION NUMBER: ACTRN12612001133820; Pre-results.

Spot urine and 24-h diet recall estimates of dietary sodium intake from the 2008/09 New Zealand Adult Nutrition Survey: a comparison.

BACKGROUND: We aimed to test the difference between estimates of dietary sodium intake using 24-h diet recall and spot urine collection in a large sample of New Zealand adults. METHODS: We analysed spot urine results, 24-h diet recall, dietary habits questionnaire and anthropometry from a representative sample of 3312 adults aged 15 years and older who participated in the 2008/09 New Zealand Adult Nutrition Survey. Estimates of adult population sodium intake were derived from 24-h diet recall and spot urine sodium using a formula derived from analysis of INTERSALT data. Correlations, limits of agreement and mean difference were calculated for the total sample, and for population subgroups. RESULTS: Estimated total population 24-h urinary sodium excretion (mean (95% CI)) from spot urine samples was 3035 mg (2990, 3079); 3612 mg (3549, 3674) for men and 2507 mg (2466, 2548) for women. Estimated mean usual daily sodium intake from 24-h diet recall data (excluding salt added at the table) was 2564 mg (2519, 2608); 2849 mg (2779, 2920) for men and 2304 mg (2258, 2350) for women. Correlations between estimates were poor, especially for men, and limits of agreement using Bland-Altman mean difference analysis were wide. CONCLUSIONS: There is a poor agreement between estimates of individual sodium intake from spot urine collection and those from 24-hour diet recall. Although, both 24-hour dietary recall and estimated urinary excretion based on spot urine indicate mean population sodium intake is greater than 2 g, significant differences in mean intake by method deserve further investigation in relation to the gold standard, 24-hour urinary sodium excretion.

Modified Version of Baby-Led Weaning Does Not Result in Lower Zinc Intake or Status in Infants: A Randomized Controlled Trial.

BACKGROUND: Little is known about zinc intakes and status during complementary feeding. This is particularly true for baby-led approaches, which encourage infants to feed themselves from the start of complementary feeding, although self-feeding may restrict the intake of zinc-rich foods. OBJECTIVE: To determine the zinc intakes, sources, and biochemical zinc status of infants following Baby-Led Introduction to SolidS (BLISS), a modified version of Baby-Led Weaning (BLW), compared with traditional spoon-feeding. DESIGN: Secondary analysis of the BLISS randomized controlled trial. PARTICIPANTS/SETTING: Between 2012 and 2014, 206 community-based participants from Dunedin, New Zealand were randomized to a Control or BLISS group. INTERVENTION: BLISS participants received eight study visits (antenatal to 9 months) providing education and support regarding BLISS (ie, infant self-feeding from 6 months with modifications to address concerns about iron, choking, and growth). MAIN OUTCOME MEASURES: Dietary zinc intakes at 7 and 12 months (weighed 3-day diet records) and zinc status at 12 months (plasma zinc concentration). STATISTICAL ANALYSES PERFORMED: Regression analyses were used to investigate differences in dietary intakes and zinc status by group, adjusted for maternal education and parity and infant age and sex. RESULTS: There were no significant differences in zinc intakes between BLISS and Control infants at 7 (median: 3.5 vs 3.5 mg/day; P=0.42) or 12 (4.4 vs 4.4 mg/day; P=0.86) months. Complementary food groups contributing the most zinc at 7 months were "vegetables" for Control infants, and "breads and cereals" for BLISS infants, then "dairy" for both groups at 12 months. There was no significant difference in mean±standard deviation plasma zinc concentration between the Control (62.8±9.8 µg/dL [9.6±1.5 µmol/L]) and BLISS (62.8±10.5 µg/dL [9.6±1.6 µmol/L]) groups (P=0.75). CONCLUSIONS: BLISS infants achieved similar zinc intake and status to Control infants. However, the BLISS intervention was modified to increase iron intake, which may have improved zinc intake, so these results should not be generalized to infants following unmodified BLW.

High-Intensity Interval Training in the Real World: Outcomes from a 12-Month Intervention in Overweight Adults.

PURPOSE: Although high-intensity interval training (HIIT) and moderate-intensity continuous exercise have comparable health outcomes in the laboratory setting, effectiveness studies in real-world environments are lacking. The aim of this study was to determine the effectiveness of an unsupervised HIIT program in overweight/obese adults over 12 months. METHODS: Two hundred and fifty overweight/obese adults could choose HIIT or current exercise guidelines of 30 min·d moderate-intensity exercise. HIIT participants received a single training session and were advised to independently perform HIIT three times per week using a variety of protocols. Mixed models, with a random effect for participant, compared differences in weight, body composition, blood pressure, aerobic fitness, physical activity, and blood indices at 12 months, adjusting for relevant baseline variables. RESULTS: Forty-two percent (n = 104) of eligible participants chose HIIT in preference to current guidelines. At 12 months, there were no differences between exercise groups in weight (adjusted difference HIIT vs conventional = -0.44 kg; 95% confidence interval [CI] = -2.5 to 1.6) or visceral fat (-103 cm; -256 to 49), although HIIT participants reported greater enjoyment of physical activity (P = 0.01). Evidence of adherence to ≥2 sessions per week of unsupervised HIIT (from HR monitoring) declined from 60.8% at baseline to 19.6% by 12 months. Participants remaining adherent to HIIT over 12 months (23%) were more likely to be male (67% vs 36%, P = 0.03), with greater reductions in weight (-2.7 kg; -5.2 to 0.2) and visceral fat (-292 cm; -483 to -101) than nonadherent participants. CONCLUSIONS: HIIT was well accepted by overweight adults, and opting for HIIT as an alternative to standard exercise recommendations led to no difference in health outcomes after 12 months. Although regular participation in unsupervised HIIT declined rapidly, those apparently adherent to regular HIIT demonstrated beneficial weight loss and visceral fat reduction. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12615000010594), retrospectively registered.

Modifiable "Predictors" of Zinc Status in Toddlers.

Suboptimal zinc status is common in very young children and likely associated with increased risk of infection and detrimental effects on growth. No studies have determined potentially modifiable "predictors" of zinc status in toddlers from high-income countries. This cross-sectional analysis of 115 toddlers from the Baby-Led Introduction to SolidS (BLISS) study used weighed diet records (three non-consecutive days) to assess dietary intake, and a venous blood sample (trace-element free techniques) to assess plasma zinc, at 12 months of age. "Predictors" of plasma zinc were determined by univariate analysis and multiple regression. Mean (SD) plasma zinc was 9.7 (1.5) µmol/L, 60% were below the IZiNCG reference limit of <9.9 µmol/L. Median (25th, 75th percentiles) intake of zinc was 4.4 (3.7, 5.4) mg/day. Red meat intake (p = 0.004), consumption of zinc-fortified infant formula (3-6 mg zinc/100 g) (p = 0.026), and food fussiness (p = 0.028) were statistically significant "predictors" of plasma zinc at 12 months. Although higher intakes of red meat, and consumption of infant formula, are potentially achievable, it is important to consider possible barriers, particularly impact on breastfeeding, cost, and the challenges of behavior modification. Of interest is the association with food fussiness-further research should investigate the direction of this association.

Sleep patterns in children differ by ethnicity: cross-sectional and longitudinal analyses using actigraphy.

OBJECTIVES: To determine whether sleep patterns (duration, timing, efficiency) differ by ethnicity. DESIGN: Longitudinal study. SETTING: Dunedin, New Zealand. PARTICIPANTS: A total of 939 children (48% male) aged 4-12 years (572 European, 181 Maori, 111 Pacific, 75 Asian). MEASUREMENTS: All measurements were obtained at months 0, 12, and 24. Anthropometry was obtained using standard techniques, and parents completed questionnaires assessing demographics, dietary intake, and television habits of children. Sleep and physical activity were measured using Actigraph accelerometers over 1 week. Differences in sleep outcomes according to ethnicity were adjusted for demographics, weight status, and behavioral variables using mixed models. RESULTS: Pacific children had greater body mass index and were more likely to live in deprived areas than children from other ethnic groups (all P<.001), but few differences were observed in behavioral variables. Pacific Island children slept 16 (95% confidence interval, 7-25) minutes less per night than New Zealand European children, predominantly as a result of later bedtimes (29; 20-38 minutes). By contrast, sleep efficiency did not differ by ethnicity or over time (all P≥.118). Maori children did not show the same relative deficits in sleep, displaying similar results to European children. Sleep duration decreased by 8 minutes (95% confidence interval, 6-10) a night each year over 2 years, and change over time did not differ by ethnicity (all P≥.165). CONCLUSIONS: From a young age, Pacific children had poorer sleep patterns than European children, and these patterns were maintained over 2 years.

The Pepi-Pod study: Overnight video, oximetry and thermal environment while using an in-bed sleep device for sudden unexpected death in infancy prevention.

AIM: The aim of this study was to identify the potential risks and benefits of sleeping infants in a Pepi-Pod distributed to families with high risk of sudden unexpected death in infancy compared to a bassinet. METHODS: Forty-five mostly indigenous Maori mothers who were referred by local health providers to receive a Pepi-Pod were surveyed at recruitment, 1 and 3 months. A sleep study at 1 month included infrared video, oximetry and temperature measures. RESULTS: When compared with 89 historical bassinet controls, an intention-to-treat analysis of questionnaires showed no increase in direct bed sharing but demonstrated significantly less sharing of the maternal bedroom at both interviews, with the majority of those not sleeping in the maternal bedroom, actually sleeping in the living room. The 1 month 'as-used' analysis showed poorer maternal sleep quality. The 'as-used' analysis of video data (24 Pepi-Pod and 113 bassinet infants) also showed no increase in direct bed sharing, head covering or prone/side sleep position. Differences in oxygen saturation were not significant, but heart rate was higher in the Pepi-Pod infants by 8.37 bpm (95% confidence interval 4.40, 12.14). Time in the thermal comfort zone was not different between groups despite Pepi-Pod infants being situated in significantly warmer rooms. CONCLUSIONS: Overall, we found that most differences in infant risk behaviours in a Pepi-Pod compared to a bassinet were small, with confidence intervals excluding meaningful differences. We noted poorer maternal sleep quality at 1 month. Higher infant heart rates in the Pepi-Pod group may be related to higher room temperatures. The Pepi-Pod appears physiologically safe but is associated with lower reported maternal sleep quality.

Physiological stability in an indigenous sleep device: a randomised controlled trial.

OBJECTIVE: To compare overnight oxygen saturation, heart rate and the thermal environment of infants sleeping in an indigenous sleep device (wahakura) or bassinet to identify potential risks and benefits. DESIGN: Randomised controlled trial. SETTING: Family homes in low socio-economic areas in New Zealand. PATIENTS: 200 mainly Maori mothers and their infants. INTERVENTIONS: Participants received a wahakura or bassinet from birth. MAIN OUTCOME MEASURES: Overnight oximetry, heart rate and temperature at 1 month. RESULTS: Intention-to-treat analysis for 83 bassinet and 84 wahakura infants showed no significant differences between groups for the mean time oxygen saturation (SpO2) was less than 94% (0.54 min, 95% CI -1.36 to 2.45) or less than 90% (0.22 min, 95% CI -0.56 to 1.00), the mean number of SpO2 dips per hour >5% (-0.19, 95% CI -3.07 to 2.69) or >10% (-0.41, 95% CI -1.63 to 0.81), mean heart rate (1.99 beats/min, 95% CI -1.02 to 4.99), or time shin temperature >36°C (risk ratio (RR): 0.63, 95% CI 0.13 to 2.99) or <34°C (RR: 0.89, 95% CI 0.61 to 1.30). A per-protocol analysis of 45 bassinet and 26 wahakura infants and an as-used analysis of 104 infants in a bassinet and 48 in a wahakura found no significant differences between groups for all outcome measures. CONCLUSIONS: This indigenous sleep device is at least as safe as the currently recommended bassinet, which supports its use as a sleep environment that offers an alternative way of bed-sharing. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry: ACTRN12610000993099.

The Effect of a Diet Moderately High in Protein and Fiber on Insulin Sensitivity Measured Using the Dynamic Insulin Sensitivity and Secretion Test (DISST).

Evidence shows that weight loss improves insulin sensitivity but few studies have examined the effect of macronutrient composition independently of weight loss on direct measures of insulin sensitivity. We randomised 89 overweight or obese women to either a standard diet (StdD), that was intended to be low in fat and relatively high in carbohydrate (n = 42) or to a relatively high protein (up to 30% of energy), relatively high fibre (>30 g/day) diet (HPHFib) (n = 47) for 10 weeks. Advice regarding strict adherence to energy intake goals was not given. Insulin sensitivity and secretion was assessed by a novel method-the Dynamic Insulin Sensitivity and Secretion Test (DISST). Although there were significant improvements in body composition and most cardiometabolic risk factors on HPHFib, insulin sensitivity was reduced by 19.3% (95% CI: 31.8%, 4.5%; p = 0.013) in comparison with StdD. We conclude that the reduction in insulin sensitivity after a diet relatively high in both protein and fibre, despite cardiometabolic improvements, suggests insulin sensitivity may reflect metabolic adaptations to dietary composition for maintenance of glucose homeostasis, rather than impaired metabolism.