Randomised trial on effect of involving media reporters in salt reduction programme to increase media reports and the public’s knowledge, belief and behaviors on salt and health: Changzhi reporters trial

Objective To assess the effects of a novel mass media intervention in increasing media reports on salt and health by involving media reporters in a scientifically well designed salt reduction trial. Methods We recruited and trained 66 media reporters in Changzhi, Shanxi province, China to conduct a randomized controlled trial on blood pressure lowering effect of salt substitute in Dec, 2012 and Jan 2013 among their own relatives or friends (253 from 129 families in the salt substitute arm and 263 from 133 families in the control arm for two months). We shared trial results and other information on salt and health with the reporters within a month after the trial. We monitored all local newspapers for the number of relevant articles in 3 months before, 3 months during and 3 months after the intervention and at the 6th, 12th, 18th, 24th and 48th months after the intervention. Additionally, we conducted two independent surveys on knowledge, belief and behaviours of salt and health among local citizens before and after the intervention. Results As expected, systolic blood pressure was reduced significantly more in the salt substitute than the control group (-4.7±11.0 mmHg vs -2.6±10.3 mmHg, p<0.001) in the randomized trial. The monthly mean number of relevant articles increased from 0.7 before to 1.7 during (p = 0.263), and further to 6.0 after the intervention (p<0.001), and varied from 2 (p = 0.170) to 4 (p = 0.008) from the 6th to 48th month; the awareness of knowledge on salt and health among local citizens improved significantly after the intervention. Conclusions Media reporters’ participation in a well-designed salt reduction trial significantly increased the number of relevant media reports, and the effect was sustained for a prolonged period. Future mass media public health education programs should consider this innovative strategy for better and sustained impacts.

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Blood Pressure and Dietary Polyunsaturated and Saturated Fats: A Controlled Trial

Clinical Science ◽

10.1042/cs0690165 ◽

1985 ◽

Vol 69 (2) ◽

pp. 165-175 ◽

Cited By ~ 38

Author(s):

Barrie M. Margetts ◽

Lawrence J. Beilin ◽

Bruce K. Armstrong ◽

Ian L. Rouse ◽

Robert Vandongen ◽

...

Keyword(s):

Blood Pressure ◽

Plasma Lipids ◽

Controlled Trial ◽

Saturated Fat ◽

Vegetarian Diet ◽

Control Group ◽

Blood Pressure Lowering Effect ◽

Diet Records ◽

Pressure Lowering ◽

Pressure Changes

1. Fifty-four healthy, omnivore normotensive volunteers aged 20-59 years were randomly allocated either to a control group eating a low polyunsaturated to saturated fat ratio (P/S ratio) diet (0.3) throughout, or to one of two experimental groups eating a high P/S ratio diet (1.0) for one of two 6-week experimental periods. Changes in other components were avoided. 2. Twenty-four hour diet records showed substantial changes in the P/S ratio for experimental groups when on the high P/S ratio diet (0.3 to 1.0). 3. There were significant increases in relative concentrations of linoleic acid in plasma phospholipids when on the high P/S ratio diet. 4. There was no consistent effect of dietary P/S ratio elevation from 0.3 to 1.0 on group mean systolic and diastolic blood pressures. Adjustment of blood pressure changes for changes in electrolytes, other dietary components, plasma lipids, weight and other lifestyle variables did not alter this result. 5. It was concluded that the blood pressure lowering effect of a vegetarian diet reported previously was unlikely to have been due to changes in dietary P/S ratio.

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Cost-effectiveness analysis of population salt reduction interventions to prevent cardiovascular disease in Cameroon: mathematical modelling study

BMJ Open ◽

10.1136/bmjopen-2020-041346 ◽

2020 ◽

Vol 10 (11) ◽

pp. e041346

Author(s):

Leopold Ndemnge Aminde ◽

Linda Cobiac ◽

J. Lennert Veerman

Keyword(s):

Cost Effectiveness ◽

Mass Media ◽

Sodium Salt ◽

Education Programme ◽

School Education ◽

Salt Reduction ◽

Low Sodium ◽

Salt Substitute ◽

Reduction Strategies ◽

The Cost

BackgroundReducing dietary sodium (salt) intake has been proposed as a population-wide strategy to reduce blood pressure and cardiovascular disease (CVD). The cost-effectiveness of such strategies has hitherto not been investigated in Cameroon.MethodsA multicohort multistate life table Markov model was used to evaluate the cost-effectiveness of three population salt reduction strategies: mass media campaign, school-based salt education programme and low-sodium salt substitute. A healthcare system perspective was considered and adults alive in 2016 were simulated over the life course. Outcomes were changes in disease incidence, mortality, health-adjusted life years (HALYs), healthcare costs and incremental cost-effectiveness ratios (ICERs) over the lifetime. Probabilistic sensitivity analysis was used to quantify uncertainty.ResultsOver the life span of the cohort of adults alive in Cameroon in 2016, substantial numbers of new CVD events could be prevented, with over 10 000, 79 000 and 84 000 CVD deaths that could be averted from mass media, school education programme and salt substitute interventions, respectively. Population health gains over the lifetime were 46 700 HALYs, 348 800 HALYs and 368 400 HALYs for the mass media, school education programme and salt substitute interventions, respectively. ICERs showed that all interventions were dominant, with probabilities of being cost-saving of 84% for the school education programme, 89% for the mass media campaign and 99% for the low sodium salt substitute. Results were largely robust in sensitivity analysis.ConclusionAll the salt reduction strategies evaluated were highly cost-effective with very high probabilities of being cost-saving. Salt reduction in Cameroon has the potential to save many lives and offers good value for money.

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E-healthcare for diabetes mellitus type 2 patients – a randomised controlled trial in Slovenia

Slovenian Journal of Public Health ◽

10.1515/sjph-2017-0020 ◽

2017 ◽

Vol 56 (3) ◽

pp. 150-157 ◽

Cited By ~ 2

Author(s):

Rade Iljaž ◽

Andrej Brodnik ◽

Tatjana Zrimec ◽

Iztok Cukjati

Keyword(s):

Diabetes Mellitus ◽

Blood Pressure ◽

Nurse Practitioners ◽

Controlled Trial ◽

Control Group ◽

Web Based ◽

Patients With Diabetes ◽

Randomised Controlled ◽

Interventional Group

Abstract Background Telemonitoring and web-based interventions are increasingly used in primary-care practices in many countries for more effective management of patients with diabetes mellitus (DM). A new approach in treating patients with diabetes mellitus in family practices, based on ICT use and nurse practitioners, has been introduced and evaluated in this study. Method Fifteen Slovene family practices enrolled 120 DM patients treated only with a diet regime and/or tablets into the study. 58 of them were included into the interventional group, and the other 62 DM patients into the control group, within one-year-long interventional, randomised controlled trial. Patients in the control group had conventional care for DM according to Slovenian professional guidelines, while the patients in the interventional group were using also the eDiabetes application. Patients were randomised through a balanced randomisation process. Results Significant reductions of glycated haemoglobin (HbA1c) values were found after 6 and 12 months among patients using this eDiabetes application (p<0.05). Among these patients, a significant correlation was also found between self-monitored blood pressure and the final HbA1c values. Diabetic patients’ involvement in web-based intervention had only transient impact on their functional health status. Conclusion This eDiabetes application was confirmed to be an innovative approach for better self-management of DM type 2 patients not using insulin. Both a significant reduction of HbA1c values and a significant correlation between the average self-measured blood pressure and the final HbA1c values in the interventional group were found. Nurse practitioners – as diabetes care coordinators – could contribute to better adherence in diabetes e-care.

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Effect of riboflavin supplementation on blood pressure and possible effect modification by the MTHFR C677T polymorphism: a randomised trial in rural Gambia

F1000Research ◽

10.12688/f1000research.25113.1 ◽

2020 ◽

Vol 9 ◽

pp. 1034

Author(s):

Modou Jobe ◽

Mary Ward ◽

Bakary Sonko ◽

Abdul Khalie Muhammad ◽

Ebrima Danso ◽

...

Keyword(s):

Blood Pressure ◽

Large Scale ◽

Methylenetetrahydrofolate Reductase ◽

Controlled Trial ◽

Randomised Trial ◽

Mthfr C677t ◽

C677t Polymorphism ◽

Phenotypic Effect ◽

Riboflavin Deficiency ◽

Mthfr C677t Polymorphism

Introduction: Emerging evidence links a functional polymorphism in the methylenetetrahydrofolate reductase (MTHFR) gene (rs1801133) with hypertension in adults. This variant reduces the affinity of MTHFR for its cofactor flavin-adenine dinucleotide (FAD) which is derived from riboflavin. Previous work has demonstrated a blood pressure (BP)-lowering effect of riboflavin in Irish adults with the MTHFR 677TT variant. We hypothesize that the almost-universal severe riboflavin deficiency seen in rural Gambia mimics the BP phenotypic effect of the TT variant and exacerbate the effect of the CT variant. We will test this in a randomised, placebo-controlled trial, whether intervention with riboflavin can decrease BP in adults in rural Gambia. Methods: This is a phase 2 recall-by-genotype randomised single-blind placebo-controlled riboflavin supplementation trial. We will use the Keneba biobank to recruit approximately 102 individuals aged between 18-70, previously genotyped for the MTHFR C677T polymorphism and identified as carrying the T allele; these individuals will be age- and sex-matched to a similar number of homozygotes for the C allele. The participants will be randomised to a 16-week supplementation trial of 5 mg/day riboflavin or placebo, supplied every 14 days. The primary outcome, BP, will be measured at baseline and at weeks 8 and 16. Blood samples, collected at baseline and week 16, will be analysed for riboflavin, homocysteine, red cell folate, cobalamin (vitamin B12) and pyridoxine (vitamin B6). Discussion: The study will evaluate the role of riboflavin supplementation in BP control within a population with high levels of riboflavin deficiency and will test a possible gene-nutrient interaction with the MTHFR C677T polymorphism. If improvements in BP are observed in this study, and proven in subsequent large-scale interventions, riboflavin could offer a cost-effective, safe and accessible option for the prevention and control of hypertension in this population. Trial registration: ClinicalTrials.gov Identifier NCT03151096. Registered on 12 May 2017.

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The Effects of a Preconception Lifestyle Intervention on Childhood Cardiometabolic Health—Follow-Up of a Randomized Controlled Trial

Cells ◽

10.3390/cells11010041 ◽

2021 ◽

Vol 11 (1) ◽

pp. 41

Author(s):

Stijn Mintjens ◽

Mireille N. M. van Poppel ◽

Henk Groen ◽

Annemieke Hoek ◽

Ben Willem Mol ◽

...

Keyword(s):

Blood Pressure ◽

Lifestyle Intervention ◽

Maternal Obesity ◽

Controlled Trial ◽

Cardiometabolic Health ◽

Control Group ◽

Z Score ◽

Infertile Women ◽

Z Scores

Maternal obesity is associated with adverse metabolic outcomes in her offspring, from the earliest stages of development leading to obesity and poorer cardiometabolic health in her offspring. We investigated whether an effective preconception lifestyle intervention in obese women affected cardiometabolic health of their offspring. We randomly allocated 577 infertile women with obesity to a 6-month lifestyle intervention, or to prompt infertility management. Of the 305 eligible children, despite intensive efforts, 17 in the intervention and 29 in the control group were available for follow-up at age 3–6 years. We compared the child’s Body Mass Index (BMI) Z score, waist and hip circumference, body-fat percentage, blood pressure Z scores, pulse wave velocity and serum lipids, glucose and insulin concentrations. Between the intervention and control groups, the mean (±SD) offspring BMI Z score (0.69 (±1.17) vs. 0.62 (±1.04)) and systolic and diastolic blood pressure Z scores (0.45 (±0.65) vs. 0.54 (±0.57); 0.91 (±0.66) vs. 0.96 (±0.57)) were similar, although elevated compared to the norm population. We also did not detect any differences between the groups in the other outcomes. In this study, we could not detect effects of a preconception lifestyle intervention in obese infertile women on the cardiometabolic health of their offspring. Low follow-up rates, perhaps due to the children’s age or the subject matter, combined with selection bias abating contrast in periconceptional weight between participating mothers, hampered the detection of potential effects. Future studies that account for these factors are needed to confirm whether a preconception lifestyle intervention may improve the cardiometabolic health of children of obese mothers.

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The Effect of Oxymel Syrup on Some Cardiovascular Risk Factors in Overweight and Obese People: A Randomized Controlled Trial Study

Traditional and Integrative Medicine ◽

10.18502/tim.v6i3.7307 ◽

2021 ◽

Author(s):

Marjan Mahdavi Roshan ◽

Arsalan Salari ◽

Sogol Emaminejad ◽

Shirin Parvinroo ◽

Asieh Ashouri ◽

...

Keyword(s):

Risk Factors ◽

Blood Pressure ◽

Cardiovascular Risk ◽

Controlled Trial ◽

Test Group ◽

The Body ◽

Risk Indicators ◽

Blood Cholesterol ◽

Control Group ◽

Obese People

High blood pressure, diabetes, hyperlipidemia and obesity are risk factors for cardiovascular diseases. With regard to the significant role of a healthy diet in the prevention and even treatment of diseases together with the high cost and side effects of drugs, finding foods effective in the treatment of metabolic disorders has been widely considered. This study aimed to evaluate the effect of oxymel – an Iranian traditional syrup with vinegar base – on cardiovascular risk indicators in obese and overweight people. Candidates were selected based on a set of inclusion criteria and were divided into two groups of control and test. The control group received 250 cc of water, while the test group received 250 cc water containing 30 cc of the oxymel for 30 days. Anthropometric and biochemical indicators were measured at the beginning and end of the study. The results showed that there were no significant changes in the body mass index, waist circumference, hip circumference, waist to hip ratio, HDL, LDL, Triglycerides, systolic and diastolic blood pressure, and blood glucose level. However, weight (P = 0.053) and cholesterol (P = 0.083) decreased relatively significantly in the test group compared to the control group. This study shows that consumption of oxymel has positive cardiovascular effects such as lowering the blood cholesterol level and can contribute to weight loss; however, studies with a larger sample size are recommended.

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Abstract P034: The Effectiveness of 12-week Tai Chi Training on the Migraine Attack Days, Body Composition, and Blood Pressure in Chinese Women With Episodic Migraine: A Randomized Controlled Trial

Circulation ◽

10.1161/circ.137.suppl_1.p034 ◽

2018 ◽

Vol 137 (suppl_1) ◽

Author(s):

Yao Jie Xie ◽

Stanley Sai-chuen Hui ◽

Suzanne C. Ho ◽

Lorna Kwai Ping Suen

Keyword(s):

Blood Pressure ◽

Migraine Attack ◽

Body Fat ◽

Tai Chi ◽

Chinese Women ◽

Controlled Trial ◽

Episodic Migraine ◽

Control Group ◽

Randomized Controlled ◽

The Difference

Background: Tai Chi is a body-mind exercise. It’s prophylactic efficacy on migraine attack remains largely unknown. The purpose of this study was to examine the effect of a 12-week Tai Chi training on the migraine attack days per month, body composition, and blood pressure (BP) in a sample of Chinese women with episodic migraine. Method: A two-arm randomized controlled trial was designed. Eighty-two local women aged 18 to 65 years and diagnosed with episodic migraine were randomized to the Tai Chi group or the waiting list control group. A modified 32-short form Yang-style Tai Chi training with 1 hour per day, 5 days per week for 12 weeks was adopted as intervention. An additional 12 weeks follow was conducted. The control group received a “delayed” Tai Chi training at the end of the trial. The difference in migraine days between 1 month before baseline, 3rd month (12nd week) and 6th month (24th week) after the randomization were examined. The changes in weight, body fat, and BP before and after the intervention were also analyzed. Results: Of 189 women screened, 82 eligible women completed the baseline assessment. After randomization, 9 women withdrew immediately, finally 40 in Tai Chi group and 33 in control group were involved in the analysis. On average, women in Tai Chi group had 3.6 (95% CI: -4.7 to -2.5, P<0.01) days reduction of migraine attack. Compared with control group, the difference was statistically significant (P<0.001). Tai Chi group also lost 0.6 kg of body weight and 0.6% of body fat at the 3rd month, and 10.8 mmHg systolic BP at the 6th month, respectively (all p<0.001). The between-group difference of systolic BP was -6.9 mmHg (95% CI: -11.6 mmHg to -2.1mmHg, p<0.05), whereas no significant differences were observed regarding weight and body fat at the 3rd month (all p>0.05). Among Tai Chi group, change in systolic BP was significantly correlated to the change in migraine days (P<0.05). Conclusion: The 12-week Tai Chi training significantly decreased the frequency of migraine attack and improved the systolic BP. The association between migraine attack reduction and BP improvement needs further investigations.

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Knowledge transfer and retention of simulation-based learning for neurosurgical instruments: a randomised trial of perioperative nurses

BMJ Simulation and Technology Enhanced Learning ◽

10.1136/bmjstel-2019-000576 ◽

2020 ◽

pp. bmjstel-2019-000576

Author(s):

David B Clarke ◽

Alena I Galilee ◽

Nelofar Kureshi ◽

Murray Hong ◽

Lynne Fenerty ◽

...

Keyword(s):

Nursing Education ◽

Simulation Training ◽

Controlled Trial ◽

Randomised Trial ◽

Control Group ◽

Perioperative Nurses ◽

Instrument Recognition ◽

Simulation Based ◽

Group A ◽

Group B

IntroductionPrevious studies have shown that simulation is an acceptable method of training in nursing education. The objectives of this study were to determine the effectiveness of tablet-based simulation in learning neurosurgical instruments and to assess whether skills learnt in the simulation environment are transferred to a real clinical task and retained over time.MethodsA randomised controlled trial was conducted. Perioperative nurses completed three consecutive sessions of a simulation. Group A performed simulation tasks prior to identifying real instruments, whereas Group B (control group) was asked to identify real instruments prior to the simulation tasks. Both groups were reassessed for knowledge recall after 1 week.ResultsNinety-three nurses completed the study. Participants in Group A, who had received tablet-based simulation, were 23% quicker in identifying real instruments and did so with better accuracy (93.2% vs 80.6%, p<0.0001) than Group B. Furthermore, the simulation-based learning was retained at 7 days with 97.8% correct instrument recognition in Group A and 96.2% in Group B while maintaining both speed and accuracy.ConclusionThis is the first study to assess the effectiveness of tablet-based simulation training for instrument recognition by perioperative nurses. Our results demonstrate that instrument knowledge acquired through tablet-based simulation training results in improved identification and retained recognition of real instruments.

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Effect of Steamed Potato Bread Intake on Glucose, Lipids, and Urinary Na+ and K+: A Randomized Controlled Trial with Adolescents

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17062096 ◽

2020 ◽

Vol 17 (6) ◽

pp. 2096

Author(s):

Haiquan Xu ◽

Yanzhi Guo ◽

Shijun Lu ◽

Yunqian Ma ◽

Xiuli Wang ◽

...

Keyword(s):

Blood Pressure ◽

Randomized Controlled Trial ◽

Systolic Blood Pressure ◽

Total Cholesterol ◽

Controlled Trial ◽

Intervention Group ◽

High Density Lipoproteins ◽

Control Group ◽

Randomized Controlled ◽

Potato Bread

Although potatoes are highly nutritious, many epidemiological studies have connected their consumption with abnormal lipids, diabetes, and hypertension. Steamed potato bread has recently become one of China’s staple foods. A randomized controlled trial was designed to evaluate the effect of steamed potato bread consumption on Chinese adolescents. Four classes from a high school were randomly selected and assigned to the intervention group (two classes) or control group (two classes). The steamed wheat bread (100% raw wheat flour) and potato bread (raw wheat flour to cooked potato flour ratio of 3:7) were provided to the control group and intervention group as staple food once a school day for 8 weeks, respectively. Compared with the control group, the intervention group had significant net changes in systolic blood pressure (4.6 mmHg, p = 0.010), insulin (−4.35 mIU/L, p < 0.001), total cholesterol (−0.13 mmol/L, p = 0.032), and high-density lipoproteins cholesterol (−0.07 mmol/L, p = 0.010). The urinary level of Na+/K+ did not differ between the groups. In conclusion, the intake of steamed potato bread for 8 weeks resulted in positive effects on the total cholesterol and insulin profiles but a negative effect on the systolic blood pressure and high-density lipoproteins cholesterol of adolescents.

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Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults

BMJ Open ◽

10.1136/bmjopen-2020-041437 ◽

2020 ◽

Vol 10 (9) ◽

pp. e041437

Author(s):

Florence Ader

Keyword(s):

Controlled Trial ◽

Clinical Status ◽

Antiviral Agents ◽

Randomised Trial ◽

Phase Iii ◽

Ordinal Scale ◽

Control Group ◽

National Agency ◽

Open Label ◽

Hospitalised Patients

IntroductionTo find effective and safe treatments for COVID-19, the WHO recommended to systemically evaluate experimental therapeutics in collaborative randomised clinical trials. As COVID-19 was spreading in Europe, the French national institute for Health and Medical Research (Inserm) established a transdisciplinary team to develop a multi-arm randomised controlled trial named DisCoVeRy. The objective of the trial is to evaluate the clinical efficacy and safety of different investigational re-purposed therapeutics relative to Standard of Care (SoC) in patients hospitalised with COVID-19.Methods and analysisDisCoVeRy is a phase III, open-label, adaptive, controlled, multicentre clinical trial in which hospitalised patients with COVID-19 in need of oxygen therapy are randomised between five arms: (1) a control group managed with SoC and four therapeutic arms with re-purposed antiviral agents: (2) remdesivir + SoC, (3) lopinavir/ritonavir + SoC, (4) lopinavir/ritonavir associated with interferon (IFN)-β−1a + SoC and (5) hydroxychloroquine + SoC. The primary endpoint is the clinical status at Day 15 on the 7-point ordinal scale of the WHO Master Protocol (V.3.0, 3 March 2020). This trial involves patients hospitalised in conventional departments or intensive care units both from academic or non-academic hospitals throughout Europe. A sample size of 3100 patients (620 patients per arm) is targeted. This trial has begun on 22 March 2020. Since 5 April 2020, DisCoVeRy has been an add-on trial of the Solidarity consortium of trials conducted by the WHO in Europe and worldwide. On 8 June 2020, 754 patients have been included.Ethics and disseminationInserm is the sponsor of DisCoVeRy. Ethical approval has been obtained from the institutional review board on 13 March 2020 (20.03.06.51744) and from the French National Agency for Medicines and Health Products (ANSM) on 9 March 2020. Results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT04315948 Eudra-CT 2020-000936-23.

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