Effectiveness and easiness of adherence to behavioural guidelines for diet and lifestyle changes for cholesterol‐lowering: the Increasing Adherence of Consumers to Diet & Lifestyle Changes to Lower ( LDL ) Cholesterol ( ACT ) randomised controlled trial

2019 ◽  
Vol 32 (5) ◽  
pp. 607-618
Author(s):  
E. Magriplis ◽  
T. E. Sialvera ◽  
A. Papadopoulou ◽  
S. P. Efstathiou ◽  
E. A. Trautwein ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Ldl Cholesterol ◽  
Controlled Trial ◽  
Lifestyle Changes ◽  
Cholesterol Lowering ◽  
Randomised Controlled ◽  
Diet And Lifestyle

Curcumin potentiates cholesterol-lowering effects of phytosterols in hypercholesterolaemic individuals. A randomised controlled trial

Metabolism ◽  
2018 ◽  
Vol 82 ◽  
pp. 22-35 ◽  
Author(s):  
Jessica J.A. Ferguson ◽  
Elizabeth Stojanovski ◽  
Lesley MacDonald-Wicks ◽  
Manohar L. Garg
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cholesterol Lowering ◽  
Randomised Controlled

scholarly journals Feasibility Study To Assess The Delivery of A Novel Isometric Exercise Intervention For People With Stage 1 Hypertension In The NHS: Protocol For The Isofit-BP Study Including Amendments To Mitigate The Risk of COVID-19 

2021 ◽  
Author(s):  
Jonathan Wiles ◽  
Melanie Rees-Roberts ◽  
Jamie O’Driscoll ◽  
Timothy Doulton ◽  
Douglas McInnes ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Feasibility Study ◽  
Controlled Trial ◽  
Isometric Exercise ◽  
Lifestyle Changes ◽  
Lifestyle Advice ◽  
Alternative Treatment Option ◽  
Randomised Controlled ◽  
Stage 1

Abstract Background: Hypertension (HTN) affects approximately 25% of the UK population and is a leading cause of mortality. Associated annual health care costs run into billions. National treatment guidance includes initial lifestyle advice, followed by anti-hypertensive medication if blood pressure (BP) remains high. However, adoption and adherence to recommended exercise guidelines, dietary advice and anti-hypertensive medication is poor. Four short bouts of isometric exercise (IE) performed 3 days per week (d/wk) at home elicits clinically significant reductions in BP in those with normal to high-normal BP. This study will determine the feasibility of delivering personalised IE to patients with Stage 1 hypertension for whom lifestyle changes would be recommended before medication within NHS primary care.Methods: This is a randomised controlled feasibility study. Participants 18+ years, with Stage 1 hypertension, not on anti-hypertensive medication and without significant medical contraindications. Trial arms will be standard lifestyle advice (control) or isometric wall squat exercise and standard lifestyle advice. Primary outcomes include success of intervention delivery and change in BP. Secondary outcomes include accuracy of protocol delivery, execution of and adherence to protocol, recruitment rate, attrition, perception of intervention viability, cost, participant experience, and accuracy of home BP. The study will last 18 months. Sample size of 100 participants (50 per arm) allows for 20% attrition and 6.5% incomplete data, based upon 74 (37 each arm) participants (two-sided 95% confidence interval, width of 1.33 and standard deviation of 4) completing 4 weeks. Ethical approval IRAS ID: 274676.Discussion: Before the efficacy of this novel intervention to treat Stage 1 hypertension can be investigated in any large randomised controlled trial, it is necessary to ascertain if it can be delivered and carried out in a NHS primary care setting. Findings could support IE viability as a prophylactic / alternative treatment option.Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN) 13472393 registered 18 August 2020. http://www.isrctn.com/ISRCTN13472393

scholarly journals Exchanging a few commercial, regularly consumed food items with improved fat quality reduces total cholesterol and LDL-cholesterol: a double-blind, randomised controlled trial

2016 ◽  
Vol 116 (8) ◽  
pp. 1383-1393 ◽  
Author(s):  
Stine M. Ulven ◽  
Lena Leder ◽  
Elisabeth Elind ◽  
Inger Ottestad ◽  
Jacob J. Christensen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Total Cholesterol ◽  
Inflammatory Markers ◽  
Ldl Cholesterol ◽  
Controlled Trial ◽  
Diet Group ◽  
Double Blind ◽  
Food Items ◽  
Fat Quality ◽  
Randomised Controlled

AbstractThe healthy Nordic diet has been previously shown to have health beneficial effects among subjects at risk of CVD. However, the extent of food changes needed to achieve these effects is less explored. The aim of the present study was to investigate the effects of exchanging a few commercially available, regularly consumed key food items (e.g. spread on bread, fat for cooking, cheese, bread and cereals) with improved fat quality on total cholesterol, LDL-cholesterol and inflammatory markers in a double-blind randomised, controlled trial. In total, 115 moderately hypercholesterolaemic, non-statin-treated adults (25–70 years) were randomly assigned to an experimental diet group (Ex-diet group) or control diet group (C-diet group) for 8 weeks with commercially available food items with different fatty acid composition (replacing SFA with mostly n-6 PUFA). In the Ex-diet group, serum total cholesterol (P<0·001) and LDL-cholesterol (P<0·001) were reduced after 8 weeks, compared with the C-diet group. The difference in change between the two groups at the end of the study was −9 and −11 % in total cholesterol and LDL-cholesterol, respectively. No difference in change in plasma levels of inflammatory markers (high-sensitive C-reactive protein, IL-6, soluble TNF receptor 1 and interferon-γ) was observed between the groups. In conclusion, exchanging a few regularly consumed food items with improved fat quality reduces total cholesterol, with no negative effect on levels of inflammatory markers. This shows that an exchange of a few commercially available food items was easy and manageable and led to clinically relevant cholesterol reduction, potentially affecting future CVD risk.

scholarly journals Modification of diet, exercise and lifestyle (MODEL) study: a randomised controlled trial protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e036366
Author(s):  
Simone Radavelli-Bagatini ◽  
Catherine P Bondonno ◽  
Marc Sim ◽  
Lauren C Blekkenhorst ◽  
Reindolf Anokye ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Vascular Disease ◽  
Controlled Trial ◽  
Lifestyle Change ◽  
Sitting Time ◽  
Pictorial Representation ◽  
Control Group ◽  
Cvd Risk ◽  
Randomised Controlled ◽  
Diet And Lifestyle

IntroductionMost cardiovascular disease (CVD)-related events could be prevented or substantially delayed with improved diet and lifestyle. Providing information on structural vascular disease may improve CVD risk factor management, but its impact on lifestyle change remains unclear. This study aims to determine whether providing visualisation and pictorial representation of structural vascular disease (abdominal aortic calcification (AAC)) can result in healthful diet and lifestyle change.Methods and analysisThis study, including men and women aged 60–80 years, is a 12-week, two-arm, multisite randomised controlled trial. At baseline, all participants will have AAC assessed from a lateral spine image captured using a bone densitometer. Participants will then be randomised to receive their AAC results at baseline (intervention group) or a usual care control group that will receive their results at 12 weeks. All participants will receive information about routinely assessed CVD risk factors and standardised (video) diet and lifestyle advice with three simple goals: (1) increase fruit and vegetable (FV) intake by at least one serve per day, (2) improve other aspects of the diet and (3) reduce sitting time and increase physical activity. Clinical assessments will be performed at baseline and 12 weeks.OutcomesThe primary outcome is a change in serum carotenoid concentrations as an objective measure of FV intake. The study design, procedures and treatment of data will adhere to Standard Protocol Items for Randomized Trials guidelines.Ethics and disseminationEthics approval for this study has been granted by the Edith Cowan University and the Deakin University Human Research Ethics Committees (Project Numbers: 20513 HODGSON and 2019-220, respectively). Results of this study will be published in peer-reviewed academic journals and presented in scientific meetings and conferences. Information regarding consent, confidentiality, access to data, ancillary and post-trial care and dissemination policy has been disclosed in the participant information form.Trial registration numberAustralian New Zealand Clinical Trial Registry (ACTRN12618001087246).

scholarly journals Design and rationale of the MyHeartMate study: a randomised controlled trial of a game-based app to promote behaviour change in patients with cardiovascular disease

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e024269 ◽  
Author(s):  
Robyn Gallagher ◽  
Clara Chow ◽  
Helen Parker ◽  
Lis Neubeck ◽  
David Celermajer ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Secondary Prevention ◽  
Behaviour Change ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Mobile App ◽  
Lifestyle Changes ◽  
Local Health ◽  
Randomised Controlled ◽  
The Impact

IntroductionRecurrence of cardiac events is common after a first event, leading to hospitalisations and increased health burden. Patients have difficulties achieving the lifestyle changes required for secondary prevention and access to secondary prevention programs is limited. This study aims to evaluate the impact of a game-based mobile app, MyHeartMate, which is designed to motivate engagement in secondary prevention behaviours for cardiovascular risk factors.Methods and analysisThe MyHeartMate study is a randomised controlled trial with 6-month follow-up and blinded assessment of the primary outcome. Participants (n=394) with coronary heart disease will be recruited from hospitals in metropolitan Sydney and randomly allocated to standard care or the MyHeartMate app intervention. The intervention group will receive the app, which uses game techniques to promote engagement and lifestyle behaviour change for secondary prevention. The primary outcome is difference between the groups in physical activity (metabolic equivalent of task minutes/week) at 6 months. Secondary outcomes include change in low-density lipoprotein cholesterol, systolic blood pressure, medication adherence, body mass index, waist circumference, mood and dietary changes at 6 months. Data on app engagement, and patient perspectives of usability and acceptability, will also be analysed.Ethics and disseminationThe study has received ethics approval from Northern Sydney Local Health District Human Research Ethics Committee. The study findings will be disseminated via peer-reviewed publications and presentation at international scientific meetings/conferences.Trial registration numberACTRN12617000869370; Pre-results.

Re: Liam Bourke, Stephen Gilbert, Richard Hooper, et al. Lifestyle Changes for Improving Disease-specific Quality of Life in Sedentary Men on Long-term Androgen-Deprivation Therapy for Advanced Prostate Cancer: A Randomised Controlled Trial. Eur Urol 2014;65:865–72;Re: Daniel A. Galvão, Nigel Spry, James Denham, et al. A Multicentre Year-long Randomised Controlled Trial of Exercise Training Targeting Physical Functioning in Men with Prostate Cancer Previously Treated with Androgen Suppression and Radiation from TROG 03.04 RADAR. Eur Urol 2014;65:856–64;Re: Nancy L. Keating, Pang-Hsiang Liu, A. James O’Malley, Stephen J. Freedland, Matthew R. Smith. Androgen-deprivation Therapy and Diabetes Control Among Diabetic Men with Prostate Cancer. Eur Urol 2014;65:816–24;Re: Christina G. Jespersen, Mette Nørgaard, Michael Borre. Androgen-deprivation Therapy in Treatment of Prostate Cancer and Risk of Myocardial Infarction and Stroke: A Nationwide Danish Population-based Cohort Study. Eur Urol 2014;65:704–9

2014 ◽  
Vol 66 (3) ◽  
pp. e51-e52 ◽  
Author(s):  
Sanchia S. Goonewardene ◽  
Raj Persad ◽  
Annie Young ◽  
Adel Makar
Keyword(s):  
Prostate Cancer ◽  
Randomised Controlled Trial ◽  
Androgen Deprivation Therapy ◽  
Controlled Trial ◽  
Population Based ◽  
Androgen Deprivation ◽  
Lifestyle Changes ◽  
Previously Treated ◽  
Randomised Controlled

scholarly journals Translation in the making: how older people engaged in a randomised controlled trial on lifestyle changes apply medical knowledge in their everyday lives

2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Astrid P. Jespersen ◽  
Aske Juul Lassen ◽  
Thorvald Winsløw Schjeldal
Keyword(s):  
Randomised Controlled Trial ◽  
Everyday Life ◽  
Social Relations ◽  
Social Order ◽  
Controlled Trial ◽  
Medical Knowledge ◽  
Lifestyle Changes ◽  
Health Practices ◽  
Objects Of Knowledge ◽  
Randomised Controlled

AbstractA recurring discussion in recent health studies relates to knowledge translation (KT), which deals with the questions of how to ensure and measure the uptake of knowledge from one medical situation to another and of how to move the right form of knowledge from one situation to another. Recently, however, this way of understanding KT has received criticism for presenting too basic an understanding of knowledge and not fully grasping the potential of the term translation. Based on qualitative material from a randomised controlled trial (RCT) and a follow-up study, this article takes the current discussion of KT one step further, focussing on how KT happens among healthy citizens participating in a lifestyle intervention. The overall argument is that even current critical understandings of KT often ignore the fact that the translation of medical knowledge does not stop at the clinical encounter but extends into the everyday health practices of the population. A more nuanced understanding of how and in which forms medical knowledge is adopted by people in their everyday health practices will give new insights into the complex mechanisms of KT and the encounter between medical knowledge and practice and everyday life. Hence, this article discuss how knowledge from a clinical trial—focussing on muscular training and increased protein intake—is translated into meaningful health practices. The article concludes the following points: First, constant, and often precarious, work is required to maintain the content of ‘medical knowledge’ in a complex social order. Second, focussing on translation work in everyday life emphasises that KT is an open-ended process, wherein the medical object of knowledge is contested and renegotiated and needs alliances with other objects of knowledge in order to remain relevant. Last, from an everyday life perspective, medical knowledge is just one rationale making up the fabric of people’s health practices; other rationales, such as time, feasibility, logistics and social relations, are just as relevant in determining how and why people pursue healthy living or comply with a medical regimen. CALM trial registration ClinicalTrials.gov NCT02034760. Registered on 10 January 2014; ClinicalTrials.gov NCT02115698. Registered on 14 April 2014; Danish regional committee of the Capital Region H-4-2013-070. Registered on 4 July 2013; Danish Data Protection Agency 2012-58-0004–BBH-2015-001 I-Suite 03432. Registered on 9 January 2015.

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