Moderate consumption of fatty fish reduces diastolic blood pressure in overweight and obese European young adults during energy restriction

ObjectiveDietary intervention studies suggest that a daily fish meal can improve blood pressure (BP); however, such a dietary regimen might be difficult to sustain. The objective of the present study was to investigate whether salmon consumption three times per week improves BP during energy restriction in young adults.MethodsIn this 8-wk intervention, 324 subjects (20–40 y of age, body mass index 27.5–32.5 kg/m², from Iceland, Spain, and Ireland) were randomized to one of four energy-restricted diets (?30% relative to estimated requirements): salmon (150 g three times per week, resulting in a daily consumption of 2.1 g of ω-3 long-chain polyunsaturated fatty acids [ω-3 LC-PUFAs]), cod (150 g three times per week, 0.3 g of ω-3 LC-PUFAs per day), fish oil capsules (1.3 g of ω-3 LC-PUFAs per day), or control (sunflower oil capsules, no seafood). Body weight, diastolic BP (DBP), systolic BP (SBP), and docosahexaenoic acid (DHA) in erythrocyte membrane were measured at baseline and endpoint.ResultsParticipants showed weight loss (?5.2 ± 3.2 kg, P < 0.001) and decreases in SBP (?4.4 ± 8.6 mmHg, P < 0.001) and DBP (?4.1 ± 7.4 mmHg, P < 0.001) after the intervention. The salmon (B = ?2.71, P = 0.032) and fish oil (B = ?2.48, P = 0.044) groups had significantly lower endpoint DPB than the cod group, but not significantly different from control. Lower baseline DHA (percentage) in erythrocytes was associated with greater DBP reductions (B = 0.576, P = 0.017).ConclusionSalmon consumption three times per week can decrease DBP similar to fish oil and significantly more than lean fish during an 8-wk energy restriction in young overweight individuals. A lower DHA content in erythrocyte membrane at baseline, which might indentify infrequent fish eaters, is associated with a greater DBP reduction in the course of an 8-wk dietary intervention providing fatty seafood.     

Eficacia de un programa de automedida domiciliaria de la presión arterial como estrategia para disminuir la inercia terapéutica

ObjectiveTo evaluate the efficacy of a program of home blood pressure monitoring (HBPM) on therapeutic Inertia (TI) in mild-to-moderate hypertension (AHT).DesignControlled, randomised clinical trial.SettingForty six clinics in 35 primary care centres. Spain.ParticipantsA total of 232 patients with uncontrolled hypertension were included.InterventionTwo groups with 116 patients were formed: 1) Control group (CG): standard health intervention; 2) Intervention group (IG): patients who were included in the HBPM program.Main measurementsTI was calculated by the ratio: Number of patients whose pharmacological treatment was not changed in each visit/Number of patients with an average BP 140mmHg and/or 90mmHg in the general population or 130 and/or 90 mmHg in diabetics. The mean BPs and the percentage of controlled patients were calculated. The mean number of people that required an intervention in order to avoid TI was calculated (NI).ResultsA total of 209 patients completed the study, with TI in 35.64% (95% CI = 29.85%-41.43%) of the sample, and in 71.63% (95% CI = 63.9-79.36%) of the uncontrolled hypertensive patients.The TI was 22.42% (95% CI = 24.2-37%) in the IG and 50% (95% CI = 37.75-62.25) in the CG (p < .05) in visit 2, and 25.23% (95% CI = 14.84-35.62) and 46.07% (95% CI = 33.85-58.29) in the final visit for IG and CG, respectively (P < .05). The NI was 4.3.ConclusionsTI was very significant among the uncontrolled hypertensive patients. The studied interventions are effective for improving TI.     

Ambulatory blood pressure in hypertensive patients with left ventricular hypertrophy: efficacy of first-line combination perindopril/indapamide therapy

Background

Ambulatory blood pressure (BP) is more sensitive than office BP and is highly correlated with the left ventricular mass (LVM) of hypertensive patients with left ventricular hypertrophy (LVH).

Methods

In this prospectively designed ancillary study of the PICXEL trial, the effects of first-line combination perindopril/indapamide on ambulatory BP were compared with those of monotherapy with enalapril in 127 patients. Hypertensive patients with LVH received once daily either perindopril 2 mg/indapamide 0.625 mg (n = 65) or enalapril 10 mg (n = 62) for 52 weeks. Dose adjustments were allowed for uncontrolled BP. Twenty-four-hour ambulatory BP and echocardiographic parameters were measured at baseline, week 24, and week 52.

Results

At study end, both treatments significantly improved ambulatory BP compared with baseline (p ≤ 0.01). Perindopril/indapamide treatment reduced 24-hour and daytime systolic BP (SBP) and pulse pressure (PP) significantly more than enalapril treatment (p < 0.01). No significant between-group differences were noted for diastolic BP (DBP) or for night-time measurements. Trough/peak ratios were higher with perindopril/indapamide than with enalapril (88.5 vs 65.8 for SBP and 86.7 vs 63.9 for DBP, respectively). The global smoothness index was higher with perindopril/indapamide than with enalapril (6.6 vs 5.2 for SBP and 5.6 vs 4.9 for DBP, respectively). With perindopril/indapamide treatment, LVM index was significantly reduced (−9.1 g/m² from baseline; p vs baseline <0.001). More patients required dose increases with enalapril (87%) than with perindopril/indapamide (71%). No unusual safety elements were noted.

Conclusions

First-line perindopril/indapamide combination decreased ambulatory SBP and PP, and LVM more effectively than enalapril.     

Blood pressure normalization by fixed perindopril/indapamide combination in hypertensive patients with or without associate metabolic syndrome: results of the OPTIMAX 2 study

The aim of the observational pharmaco-epidemiological study Optimax II was to seek whether the pre-existence of a metabolic syndrome (MS) defined by the NCEP-ATP III criteria impacts blood pressure (BP) control in hypertensive patients receiving a fixed perindopril/indapamide combination therapy. The primary objective of the study was to compare in patients with and without MS the rate of BP control defined as a systolic BP < or = 140 mmHg and a diastolic BP < or = 90 mmHg. Patients were prospectively included and the follow-up lasted 6 months. The study population consisted of 24,069 hypertensive patients (56% men; mean age 62 +/- 11 years; 18% diabetics; mean BP at inclusion 162 +/- 13/93 +/- 9 mmHg). MS was found in 30.4% of the patients (n = 7322): 35.2% women and 20.1% men. Three therapeutic subgroups were constituted: Group A, previously untreated, received the combination therapy as initial treatment; Group B, previously treated but with unsatisfactory results and/or treatment intolerance, had its previous treatment switched to perindopril/indapamide; and Group C, previously treated, with good treatment tolerance but uncontrolled BP, received the study treatment in adjunction to the previous one. The normalization rate was 70.3% in group A, 68.4% in Group B, and 64.1% in Group C (p < 0.0001). The pre-existence of MS did not show any significant influence on these rates since BP lowering was -22.7 +/- 13.7 (SBP) and -12.0 +/- 10.0 mmHg (DBP) in patients without MS and 22.6 +/- 13.3 (SBP) and -12.1 +/- 9.7 (DBP) in those with MS. The results of this study show a significant effect of perindopril/indapamide treatment on systolic BP lowering, whatever the treatment status: initiation, switch, or adjunctive therapy, and independently from the presence or not of MS. This effect may be related to the specific vascular effect of the perindopril/indapamide combination, which has recently demonstrated in the ADVANCE trial its ability to reduce mortality, and cardiovascular and renal complications in diabetic patients.     

Joint effects of age and body mass index on the incidence of hypertension subtypes in the China Health and Nutrition Survey: A cohort study over 22 years

ObjectivesWe seek to investigate the joint effects of age and body mass index (BMI) on the incident hypertension subtypes among Chinese adults during 1989–2011.MethodsWe investigated the Incidence rates (IRs, per 100 person-years) of hypertension subtypes, adjusted relative risks (RRs) and population attributable risk percent (PAR%) of BMI for hypertension, and clarified the age-specific effect of BMI on incident hypertension utilizing a dynamic cohort study from the China Health and Nutrition Survey (CHNS) 1989–2011.ResultsNormotensive participants (n = 53,028) at baseline were included, with mean age was 41.7 (95% CI, 41.6–41.7) years old. During a total of 118,694 person years (average was 6.38 years) of follow-up, a total of 5208 incident cases of hypertension were documented. The IRs of hypertension were 4.4 (95% CI, 4.3–4.5), which increased gradually by age and BMI (P_trend < 0.001). Compared with those with BMI < 22 kg/m², the RR of hypertension was 3.13 (95% CI, 2.84–3.45) in the group with BMI ≥ 28 kg/m². The PAR% (BMI > 22 vs. BMI < 22) for hypertension in Chinese population was 32% (95% CI, 29–34%). Similar trends were observed in all age and BMI groups for both isolated systolic hypertension and systolic–diastolic hypertension, which were mainly affected by age. In contrast, the peak IR of isolated diastolic hypertension was observed in participants aged 30–49 years with higher BMIs.ConclusionsThe PAR% (IR of BP ≥ 140/90 or treatment for BMI > 22 vs. IR for BMI < 22) of elevated body weight for hypertension was 32% in Chinese population.     

Exposure to air pollution near a steel plant and effects on cardiovascular physiology: A randomized crossover study

BackgroundIron and steel industry is an important source of air pollution emissions. Few studies have investigated cardiovascular effects of air pollutants emitted from steel plants.ObjectiveWe examined the influence of outdoor air pollution in the vicinity of a steel plant on cardiovascular physiology in Sault Ste. Marie, Canada.MethodsSixty-one healthy, non-smoking subjects (females/males = 33/28, median age 22 years) spent 5 consecutive 8-hour days outdoors in a residential area neighbouring a steel plant, or on a college campus approximately 5 kilometres away from the plant, and then crossed over to the other site with a 9-day washout. Mid day, subjects underwent daily 30-minute moderate intensity exercise. Blood pressure (BP) and pulse rate were determined daily and post exercise at both sites. Flow-mediated vasodilation (FMD) was determined at the site near the plant. Air pollution was monitored at both sites. Mixed-effects regressions were run for statistical associations, adjusting for weather variables.ResultsConcentrations of ultrafine particles, sulphur dioxide (SO₂), nitrogen dioxide (NO₂) and carbon monoxide (CO) were 50–100% higher at the site near the plant than at the college site, with minor differences in temperature, humidity, and concentrations of particulate matter ≤2.5 μm in size (PM_2.5) and ozone (O₃). Resting pulse rate [mean (95% confidence interval)] was moderately higher near the steel plant [+1.53 bpm (0.31, 2.78)] than at the college site, male subjects having the highest pulse rate elevation [+2.77 bpm (0.78, 4.76)]. Resting systolic and diastolic BP and pulse pressure, and post-exercise BP and pulse rate were not significantly different between two sites. Interquartile range concentrations of SO₂ (2.9 ppb), NO₂ (5.0 ppb) and CO (0.2 ppm) were associated with increased pulse rate [0.19 bpm (−0.00, 0.38), 0.86 bpm (0.03, 1.68), and 0.11 bpm (0.00, 0.22), respectively], ultrafine particles (10,256 count/cm³) associated with increased pulse pressure [0.85 mmHg (0.23, 1.48)], and NO₂ and CO inversely associated with FMD [−0.14% (−0.31, 0.02), −0.02% (−0.03, −0.00), respectively]. SO₂ during exercise was associated with increased pulse rate [0.26 bpm (0.01, 0.51)].ConclusionAir quality in residential areas near steel plants may influence cardiovascular physiology.     

The effect of walking on risk factors for cardiovascular disease: An updated systematic review and meta-analysis of randomised control trials

ObjectiveTo conduct a systematic review and meta-analysis of randomised control trials that examined the effect of walking on risk factors for cardiovascular disease.MethodsFour electronic databases and reference lists were searched (Jan 1971–June 2012). Two authors identified randomised control trials of interventions ≥ 4 weeks in duration that included at least one group with walking as the only treatment and a no-exercise comparator group. Participants were inactive at baseline. Pooled results were reported as weighted mean treatment effects and 95% confidence intervals using a random effects model.Results32 articles reported the effects of walking interventions on cardiovascular disease risk factors. Walking increased aerobic capacity (3.04 mL/kg/min, 95% CI 2.48 to 3.60) and reduced systolic (− 3.58 mm Hg, 95% CI − 5.19 to − 1.97) and diastolic (− 1.54 mm Hg, 95% CI − 2.83 to − 0.26) blood pressure, waist circumference (− 1.51 cm, 95% CI − 2.34 to − 0.68), weight (− 1.37 kg, 95% CI − 1.75 to − 1.00), percentage body fat (− 1.22%, 95% CI − 1.70 to − 0.73) and body mass index (− 0.53 kg/m², 95% CI − 0.72 to − 0.35) but failed to alter blood lipids.ConclusionsWalking interventions improve many risk factors for cardiovascular disease.This underscores the central role of walking in physical activity for health promotion.     

Moderators of health behavior initiation and maintenance in a randomized telephone counseling trial

ObjectiveThis study compares moderators of initiation and maintenance of health behavior changes.MethodsData come from a cluster-randomized, 12-month telephone counseling intervention for physical activity and diet, targeting type 2 diabetes or hypertension patients (n = 434, Australia,2005–2007). Demographic and health-related characteristics, theoretical constructs, and baseline behavioral outcomes were considered as moderators. Mixed models, adjusting for baseline values, assessed moderation of intervention effects for trial outcomes (physical activity, intakes of fat, saturated fat, fiber, fruit, vegetables) at end-of-intervention (12 months/initiation) and maintenance follow-up (18 months), and compared moderation between these periods.ResultsSocial support for physical activity and baseline physical activity were significant (p < 0.05) moderators of physical activity at 12 months. Gender, marital status, social support for healthy eating, BMI, and number of chronic conditions were significant moderators of dietary changes at 12- and/or 18 months. Instances of moderation differing significantly between 12- and 18 months were: baseline physical activity for physical activity (initiation) and marital status for fat intake (maintenance).ConclusionsThis exploratory study showed that moderation of physical activity and diet effects sometimes differed between initiation and maintenance. To identify unique moderators for initiation and/or maintenance of behavior changes, future studies need to report on and statistically test for such differences.     

Physical activity and cardiovascular risk factors in children: meta-analysis of randomized clinical trials

ObjectiveTo assess the effects of physical activity interventions in preventing cardiovascular risk factors in childhood through a systematic review and meta-analysis of randomized clinical trials (RCTs).MethodsA search of online databases (PubMed, EMBASE and Cochrane CENTRAL) was conducted from inception until June 2013. RCTs enrolling children 6–12 years old conducted physical activity interventions longer than 6 months, assessing their effect on body mass index (BMI), systolic (SBP) and diastolic blood pressure (DBP), total cholesterol (TC) and triglycerides (TG) were included. Data analysis was performed using a random-effects model.ResultsOf 23.091 articles retrieved, 11 RCTs (10.748 subjects) were included. Physical activity interventions were not associated with reductions of BMI [− 0.03 kg/m² (95%CI − 0.16, 0.13) I² 0%]. However, there was an association between the interventions and reduction of SBP [− 1.25 mmHg (95%CI − 2.47, − 0.02) I² 0%], DBP [− 1.34 mmHg (95%CI − 2.57, − 0.11) I² 43%] and TG [− 0.09 mmol/L (95%CI − 0.14, − 0.04) I² 0%], and increase of TC [0.14 mmol/L (95%CI 0.01, 0.27) I² 0%].ConclusionAs physical activity intervention programs lasting longer than 6 months are associated with reductions in blood pressure levels and triglycerides, they should be considered to be included in prevention programs for cardiovascular diseases in schoolchildren.     

Mean arterial pressure is better at predicting future metabolic syndrome in the normotensive elderly: A prospective cohort study in Taiwan

ObjectiveTo compare four different blood pressure (BP) measurements—systolic BP (SBP), diastolic BP (DBP), mean arterial pressure (MAP), and pulse pressure (PP)—in predicting future metabolic syndrome (MetS) among the normotensive elderly population, and to estimate the optimal cutoff value of the best single measurement for clinical practice.MethodsA total of 2782 non-medicated participants aged ≥ 60 years were enrolled in a standard health examination program in Taiwan from January 2004 to December 2013. Two thirds of the participants were randomly designated as the training group (n = 1855) and the other one third as the validation group (n = 927). The mean follow-up time was 3.60 years for both the training and validation groups. MAP and PP were calculated from SBP and DBP.ResultsSBP, DBP, and MAP were associated with future MetS, whereas PP was not. MAP had the largest hazard ratio in Cox regression (men 1.342 [95% CI 1.158–1.555] and women 1.348 [95% CI 1.185–1.534] in the training group; men 1.640 [95% CI 1.317–2.041] and women 1.485 [95% CI 1.230–1.794] in the validation group) and the largest area under the receiver operating characteristic curve (men 0.598 ± 0.021 and women 0.602 ± 0.021 in the training group). Multivariable Cox regression further indicated that a higher MAP level was independently associated with the future occurrence of MetS. Participants with MAP above the cutoff value (84.0 mm Hg for men, 83.3 mm Hg for women) had a higher cumulative incidence of MetS than did their counterparts after four years' follow-up in both the training and validation groups. The results derived from the training data could be replicated in the validation data, indicating that the results were generalizable across distinct samples.ConclusionsMAP is more accurate than SBP, DBP, and PP in predicting future MetS among the normotensive geriatric population. Calculation of MAP is recommended when dealing with normotensive patients aged ≥ 60 years in clinical practice.     

The PLUNGE randomized controlled trial: Evaluation of a games-based physical activity professional learning program in primary school physical education

ObjectiveTo evaluate the efficacy of the Professional Learning for Understanding Games Education (PLUNGE) program on fundamental movement skills (FMS), in-class physical activity and perceived sporting competence.MethodsA cluster-randomized controlled trial involving one year six class each from seven primary schools (n = 168; mean age = 11.2 years, SD = 1.0) in the Hunter Region, NSW, Australia. In September (2013) participants were randomized by school into the PLUNGE intervention (n = 97 students) or the 7-week wait-list control (n = 71) condition. PLUNGE involved the use of Game Centered curriculum delivered via an in-class teacher mentoring program. Students were assessed at baseline and 8-week follow-up for three object control FMS (Test of Gross Motor Development 2), in-class physical activity (pedometer steps/min) and perceived sporting competence (Self-perception Profile for Children).ResultsLinear mixed models revealed significant group-by-time intervention effects (all p < 0.05) for object control competency (effect size: d = 0.9), and in-class pedometer steps/min (d = 1.0). No significant intervention effects (p > 0.05) were observed for perceived sporting competence.ConclusionsThe PLUNGE intervention simultaneously improved object control FMS proficiency and in-class PA in stage three students.     

Changes in cardiovascular risk factors with participation in a 12-week weight loss trial using a commercial format

ObjectiveThis study assessed changes in cardiovascular disease risk factors among participants in a 12-week behavioral weight loss intervention featuring a commercial format.Method132 participants were enrolled in a randomized controlled trial of a 12-week group-based lifestyle intervention that involved two structured food plan conditions. Of them, 112 (100 women and 12 men, mean BMI = 31.44 ± 2.18 kg/m²) completed the program with post-treatment assessments. Weight and changes in risk factors (cholesterol, triglycerides, fasting blood glucose, and blood pressure) were assessed at pre- and posttreatment. Additionally, changes for each risk factor were examined among participants with baseline values of risk factors beyond recommended cut points.ResultsWith no weight loss differences between conditions, analyses used the combined sample. Participants lost 3.74 ± 3.16 kg (4.37 ± 3.71% of baseline weight), and exhibited significant decreases in triglyceride, total cholesterol and LDL-cholesterol levels. There were trends toward reductions in fasting glucose, systolic blood pressure, and HDL cholesterol. Among participants with elevated baseline values, significant reductions were seen on all risk factors, with the exception of HDL cholesterol.DiscussionModest weight loss achieved via a relatively brief, non-intensive intervention using a commercial format can yield significant improvements in cardiovascular disease risk factors, particularly among individuals with initially higher-risk values.     

Can skin cancer prevention and early detection be improved via mobile phone text messaging? A randomised,attention control trial

ObjectiveTo test the impact of a theory-based, SMS (text message)-delivered behavioural intervention (Healthy Text) targeting sun protection or skin self-examination behaviours compared to attention control.MethodOverall, 546 participants aged 18–42 years were randomised using a computer-generated number list to the skin self-examination (N = 176), sun protection (N = 187), or attention control (N = 183) text messages group. Each group received 21 text messages about their assigned topic over 12 months (12 weekly messages for 3 months, then monthly messages for the next 9 months). Data were collected via telephone survey at baseline, 3, and 12 months across Queensland from January 2012 to August 2013.ResultsOne year after baseline, the sun protection (mean change 0.12; P = 0.030) and skin self-examination groups (mean change 0.12; P = 0.035) had significantly greater improvement in their sun protection habits (SPH) index compared to the attention control group (reference mean change 0.02). The increase in the proportion of participants who reported any skin self-examination from baseline to 12 months was significantly greater in the skin self-examination intervention group (103/163; 63%; P < 0.001) than the sun protection (83/173; 48%) or attention control (65/165; 36%) groups. There was no significant effect of the intervention for participants' self-reported whole-body skin self-examination, sun tanning, or sunburn behaviours.ConclusionThe Healthy Text intervention was effective in inducing significant improvements in sun protection and any type of skin self-examination behaviours.Trial registrationThe Australian and New Zealand Clinical Trials register (ACTRN12612000577819).FundingCancer Australia 1011999.     

Therapeutic immunisation plus cytokine and hormone therapy improves CD4 T-cell counts,restores anti-HIV-1 responses and reduces immune activation in treated chronic HIV-1 infection

BackgroundThis randomised, open label, phase I, immunotherapeutic study investigated the effects of interleukin (IL)-2, granulocyte-macrophage colony-stimulating factor (GM-CSF), recombinant human growth hormone (rhGH), and therapeutic immunisation (a Clade B DNA vaccine) on combination antiretroviral therapy (cART)-treated HIV-1-infected individuals, with the objective to reverse residual T-cell dysfunction.MethodsTwelve HIV-1⁺ patients on suppressive cART with baseline CD4 T-cell counts >400 cells/mm³ blood were randomised into one of three groups: (1) vaccine, IL-2, GM-CSF and rhGH (n = 3); (2) vaccine alone (n = 4); or (3) IL-2, GM-CSF and rhGH (n = 5). Samples were collected at weeks 0, 1, 2, 4, 6, 8, 12, 16, 24 and 48. Interferon (IFN)-γ, IL-2, IL-4 and perforin ELISpot assays performed at each time point quantified functional responses to Gag p17/p24, Nef, Rev, and Tat peptides; and detailed T-cell immunophenotyping was undertaken by flow cytometry. Proviral DNA was also measured.ResultsMedian baseline CD4 T-cell count was 757 cells/mm³ (interquartile range [IQR] 567–886 cells/mm³), median age 48 years (IQR 42–51 years), and plasma HIV-1-RNA <50 copies/ml for all subjects. Patients who received vaccine plus IL-2, GM-CSF and rhGH (group 1) showed the most marked changes. Assessing mean changes from baseline to week 48 revealed significantly elevated numbers of CD4 T cells (p = 0.0083) and improved CD4/CD8 T-cell ratios (p = 0.0033). This was accompanied by a significant reduction in expression of CD38 on CD4 T cells (p = 0.0194), significantly increased IFN-γ and IL-2 production in response to Gag (p = 0.0122) and elevated IFN-γ production in response to Tat (p = 0.041) at week 48 compared to baseline. Subjects in all treatment groups showed significantly reduced PD-1 expression at week 48 compared to baseline, with some reductions in proviral DNA.ConclusionsMultifarious immunotherapeutic approaches in the context of fully suppressive cART further reduce immune activation, and improve both CD4 T-lymphocyte counts and HIV-1-specific T-cell responses (NCT01130376).     

A case for preART-adjusted endpoints in HIV therapeutic vaccine trials

BackgroundIn a randomized, double-blind, placebo-controlled phase 2 clinical trial of Vacc-4x, a peptide-based therapeutic HIV-1 p24^Gag vaccine candidate, 135 HIV-infected participants (vaccine:placebo = 92:43) received a series of six immunizations while on combination antiretroviral therapy (cART). At week 28, all participants underwent an analytical treatment interruption (ATI) for up to 24 weeks. preART VL appeared to be higher among Vacc-4x recipients. Based on a previous analysis, during ATI viral load (VL) appeared to be lower in Vacc-4x recipients, but no difference in CD4 level was observed between Vacc-4x and placebo groups. We propose fold-change-based endpoints and report comparative analyses accounting for imbalanced preART VL and missing data.MethodsAll analyses included per-protocol (PP) participants who received the full immunization and underwent ATI. Linear regression models were used to identify predictors of study endpoints and to estimate the vaccine effect based on fold changes in CD4 counts or VL over preART values at week 40 or at set-point (geometric mean over weeks 48 and 52 values). We adjusted for potential baseline factors and used a multiple imputation approach to account for missing endpoints due to cART resumption or dropout. P-values were adjusted for multiple comparisons using q-values.ResultspreART VL and CD4 count were significant predictors of study endpoints. The vaccine recipients had a higher fold change in week 40 CD4 counts (vaccine vs. placebo mean fold-change difference = 0.08; p = 0.02; q = 0.03), a higher fold change in CD4 count set-point (0.06; p = 0.06; q = 0.07), a lower fold change in week 40 VL (−0.47; p = 0.03; q = 0.05), and a lower fold change in VL set-point (−0.50; p = 0.02; q = 0.03).ConclusionsThese exploratory analyses consistently suggested that Vacc-4x provided positive effects on both CD4 counts and VL. Future HIV therapeutic vaccine studies may adopt similar preART-adjusted endpoints and missing data imputation methods in vaccine effect evaluations.     

The associations between traffic-related air pollution and noise with blood pressure in children: Results from the GINIplus and LISAplus studies

Although traffic emits both air pollution and noise, studies jointly examining the effects of both of these exposures on blood pressure (BP) in children are scarce. We investigated associations between land-use regression modeled long-term traffic-related air pollution and BP in 2368 children aged 10 years from Germany (1454 from Munich and 914 from Wesel). We also studied this association with adjustment of long-term noise exposure (defined as day–evening–night noise indicator “Lden” and night noise indicator “Lnight”) in a subgroup of 605 children from Munich inner city. In the overall analysis including 2368 children, NO₂, PM_2.5 mass (particles with aerodynamic diameters below 2.5 μm), PM₁₀ mass (particles with aerodynamic diameters below 10 μm) and PM_2.5 absorbance were not associated with BP. When restricting the analysis to the subgroup of children with noise information (N = 605), a significant association between NO₂ and diastolic BP was observed (−0.88 (95% confidence interval: −1.67, −0.08)). However, upon adjusting the models for noise exposure, only noise remained independently and significantly positively associated with diastolic BP. Diastolic BP increased by 0.50 (−0.03, 1.02), 0.59 (0.05, 1.13), 0.55 (0.03, 1.07), and 0.58 (0.05, 1.11) mmHg for every five decibel increase in Lden and by 0.59 (−0.05, 1.22), 0.69 (0.04, 1.33), 0.64 (0.02, 1.27), and 0.68 (0.05, 1.32) mmHg for every five decibel increase in Lnight, in different models of NO₂, PM_2.5 mass, PM₁₀ mass and PM_2.5 absorbance as the main exposure, respectively. In conclusion, air pollution was not consistently associated with BP with adjustment for noise, noise was independently and positively associated with BP in children.     

The ‘Healthy Dads,Healthy Kids’ community randomized controlled trial: A community-based healthy lifestyle program for fathers and their children

ObjectiveTo evaluate the effectiveness of the ‘Healthy Dads, Healthy Kids (HDHK)’ program when delivered by trained facilitators in community settings.MethodA two-arm randomized controlled trial of 93 overweight/obese fathers (mean [SD] age = 40.3 [5.3] years; BMI = 32.5 [3.8] kg/m²) and their primary school-aged children (n = 132) from the Hunter Region, Australia. In 2010–2011, families were randomized to either: (i) HDHK intervention (n = 48 fathers, n = 72 children) or (ii) wait-list control group. The 7-week intervention included seven sessions and resources (booklets, pedometers). Assessments were held at baseline and 14-weeks with fathers' weight (kg) as the primary outcome. Secondary outcomes for fathers and children included waist, BMI, blood pressure, resting heart rate, physical activity (pedometry), and self-reported dietary intake and sedentary behaviors.ResultsLinear mixed models (intention-to-treat) revealed significant between-group differences for fathers' weight (P < .001, d = 0.24), with HDHK fathers losing more weight (− 3.3 kg; 95%CI, − 4.3, − 2.4) than control fathers (0.1 kg; 95%CI, − 0.9,1.0). Significant treatment effects (P < .05) were also found for fathers' waist (d = 0.41), BMI (d = 0.26), resting heart rate (d = 0.59), energy intake (d = 0.49) and physical activity (d = 0.46) and for children's physical activity (d = 0.50) and adiposity (d = 0.07).DiscussionHDHK significantly improved health outcomes and behaviors in fathers and children, providing evidence for program effectiveness when delivered in a community setting.     

Permanencia del efecto de una intervención de mejora de calidad en el seguimiento prolongado de pacientes hipertensos (CICLO-RISK STUDY)

ObjectiveTo evaluate the durability of the effects achieved with a quality improvement intervention on cardiovascular risk factors and cardiovascular risk, as intermediate outcomes, in hypertensive patients on long-term follow-up long time primary health care.DesignQuasi-experimental study.SettingTwo urban primary care health centres.ParticipantsThe study included 419 and 430 hypertensive patients in the intervention (IG) and control group (CG), respectively.InterventionsQuality improvement intervention consisted of a combined program including, an audit, feedback, training sessions on the main cardiovascular risk factors clinical guidelines.MeasurementsEvaluation of intermediate outcomes (blood pressure, LDL-cholesterol, HbA_1c, smoking, BMI and cardiovascular risk), were measured in both groups in March 2002, 2004 and 2006.ResultsThe mean of the durability effect (differences between IG and CG means) was: systolic blood pressure decreased from 8.9 to 4.3 and the diastolic from 3.9 to 2.3 mmHg (p<0.05). LDL-cholesterol decreased from 10 to 1.1 mg/dl (p>0.05). Coronary risk fell from 2 to 1.2 percentage points and cardiovascular mortality risk from 0.6 to 0.4 percentage points (p<0.05). The percentage of patients with blood pressure<140/90 mmHg and BMI<30 lost statistical significance in the end evaluation and only remains in the percentage of patients with coronary risk less than 20% in the 2004 and 2006 results.ConclusionsQuality improvement intervention was associated with reductions in cardiovascular risk factors and cardiovascular risk in post intervention evaluations with a tendency to decrease the effect achieved in the end evaluation.     

Prévalence de l’hypertension artérielle en population générale à la Martinique

BackgroundSince 1996, arterial hypertension has been recognized as one of the main health priorities in Martinique. However, its prevalence in the general population has never been measured. Furthermore, obesity is increasing in many countries and studies have shown that hypertension is more frequent in obese people than in people with normal body mass index. The objective of this survey is to measure hypertension prevalence in the general population and to study the link between hypertension, weight status and socioeconomic level.MethodsCross-sectional study of randomly selected homes in randomly selected geographical islets. All household members in these homes constituted the eligible population. Arterial hypertension was defined as systolic pressure greater than 140 mmHg and/or diastolic pressure greater than 90 mmHg and/or antihypertensive treatment. Weight status was estimated using the body mass index.ResultsStudy concerned 1504 persons aged 16 years or older with a sex-ratio of 0.7 and an average age of 48.3 years for men and 48.5 years for women, p = 0.88. The prevalence rate of hypertension is 29% [IC_95%: 25.9–31.8] in the sample and declines to 22.5% [IC_95%: 20.1–25.1] using weighted data. The prevalence rate is 33.1% [IC_95%: 30.2–36.6] for overweight and 20.1% [IC_95%: 17.8–22.6] for obesity. Being overweight is more frequent among persons with hypertension than among ones with normal blood pressure, 73.0 versus 47.4%; p < 0.001. In those with hypertension, overweight does not differ significantly between men and women, but the prevalence of obesity is greater among women than among men (35.7 versus 20.6 %, p < 0.05).ConclusionThe high prevalence of both hypertension and obesity in the general Martinican population has been confirmed by this study. Prevention actions are required to decrease the cardiovascular risk in this population.     

Naturally occurring deletion/insertion mutations within HBV whole genome sequences in HBeAg-positive chronic hepatitis B patients are correlated with baseline serum HBsAg and HBeAg levels and might predict a shorter interval to HBeAg loss and seroconversion during antiviral treatment

ObjectivesDeletion/insertion (Del/Ins) throughout hepatitis B virus (HBV) genome has not been well studied for HBeA-positive chronic hepatitis B (CHB) patients. This study aimed to characterize the HBV Del/Ins mutations in full-length genome quasispecies sequences in such patients at antiviral baseline and to reveal their potential impacts on HBV serological markers and responses to nucleos(t)ide analogue (NUC) treatment.Materials and methodsA total of 30 HBeAg-positive CHB patients with genotype C infection receiving a 104-week lamivudine (LMV) and adefovir dipivoxil (ADV) combination therapy were enrolled. HBV whole genome sequences in serum samples at baseline were clone sequenced and analyzed using bioinformatics tools.ResultsAmong 306 unspliced clone sequences, 61.8% (189/306) had Del/Ins mutations, 38.2% (117/306) were full-length genomes without any Del/Ins. Due to different combinations of 125 deletion types and 45 insertion types, we identified 55 Del/Ins-harboring HBV genome patterns, which affected a single or several functional genomic regions. Importantly, the proportion of Del/Ins-harboring clones was found to be significantly negatively correlated with HBsAg (r = −0.3985, P = 0.0292) and HBeAg (r = −0.3878, P = 0.0342) at baseline. Higher percentage of Del/Ins-harboring clones at baseline was found to predict a shorter interval to HBeAg loss and seroconversion.ConclusionDel/Ins mutations within HBV whole genome were prevalent in HBeAg-positive CHB patients prior to antiviral treatment. A higher detection rate of these mutations at baseline might correlate with a better response to LMV and ADV combination therapy.