Sustained Wellbeing Benefits of Red Meat Consumption in a Modern Flexitarian Diet: A Study Protocol for a 10 Week Randomised Clinical Trial (Preprint)

2021 ◽  
Author(s):  
Andrea Braakhuis ◽  
David Cameron-Smith ◽  
Scott Knowles ◽  
Tamlin Connor ◽  
Rajshri Roy ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Fatty Acid Distribution ◽  
Randomised Clinical Trial ◽  
Red Meat ◽  
Post Intervention ◽  
Animal Products ◽  
Balanced Diet ◽  
Assessment Period ◽  
Randomised Controlled

UNSTRUCTURED Background The trend of flexitarian eating patterns is on the rise, with young adults amongst the biggest adopters claiming health and environmental reasons to reduce red meat intake. Nutrient dense meat and animal products are often the lynchpin of these diets, even when consumed only occasionally and in moderate amounts. Red meat provides forms and concentrations of essential proteins, lipids, and micronutrients that are scarce in exclusively vegetarian regimens. Objective The aim of this investigation is to consider the effects of moderate consumption of lean red meat as part of an otherwise vegetarian balanced diet and its impact on biomarkers of sustained health and wellbeing. Methods A cohort of healthy, young (20-34 years) male and female participants will take part in two-arm parallel, randomised-controlled trial for a duration of 12 weeks, with a 3-month post follow-up. The trial will commence with a two-week assessment period followed by allocation to the intervention arms. The intervention will include the consumption of red meat or meat-alternatives three times per week for 10 weeks. Blood samples of the participants will be measured for changes in erythrocyte fatty acid distribution, circulating amino acids, neurotransmitters, markers of mineral status and inflammatory markers. Questionnaires to assess wellbeing and mental health will be undertaken every two weeks. Body composition, physical function test, blood measurements will be assessed at allocation (t0), week five into the intervention (t5) and post intervention (t10). Discussion To our knowledge this is the first randomised controlled trial (RCT) investigating the overarching health consequences of consuming NZ pasture fed red meat or no meat, as part of a healthy diet.

scholarly journals A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 910
Author(s):  
Dorthe Djernis ◽  
Mia S. O’Toole ◽  
Lone O. Fjorback ◽  
Helle Svenningsen ◽  
Mimi Y. Mehlsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Effect Sizes ◽  
Medium Effect ◽  
Control Group ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Self Compassion ◽  
Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

scholarly journals Digital cognitive–behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050661
Author(s):  
Håvard Kallestad ◽  
Simen Saksvik ◽  
Øystein Vedaa ◽  
Knut Langsrud ◽  
Gunnar Morken ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Patient Education ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Group Differences ◽  
Post Intervention ◽  
Cognitive Behavioural ◽  
Randomised Controlled

IntroductionInsomnia is highly prevalent in outpatients receiving treatment for mental disorders. Cognitive–behavioural therapy for insomnia (CBT-I) is a recommended first-line intervention. However, access is limited and most patients with insomnia who are receiving mental healthcare services are treated using medication. This multicentre randomised controlled trial (RCT) examines additional benefits of a digital adaptation of CBT-I (dCBT-I), compared with an online control intervention of patient education about insomnia (PE), in individuals referred to secondary mental health clinics.Methods and analysisA parallel group, superiority RCT with a target sample of 800 participants recruited from treatment waiting lists at Norwegian psychiatric services. Individuals awaiting treatment will receive an invitation to the RCT, with potential participants undertaking online screening and consent procedures. Eligible outpatients will be randomised to dCBT-I or PE in a 1:1 ratio. Assessments will be performed at baseline, 9 weeks after completion of baseline assessments (post-intervention assessment), 33 weeks after baseline (6 months after the post-intervention assessment) and 61 weeks after baseline (12 months after the post-intervention assessment). The primary outcome is between-group difference in insomnia severity 9 weeks after baseline. Secondary outcomes include between-group differences in levels of psychopathology, and measures of health and functioning 9 weeks after baseline. Additionally, we will test between-group differences at 6-month and 12-month follow-up, and examine any negative effects of the intervention, any changes in mental health resource use, and/or in functioning and prescription of medications across the duration of the study. Other exploratory analyses are planned.Ethics and disseminationThe study protocol has been approved by the Regional Committee for Medical and Health Research Ethics in Norway (Ref: 125068). Findings from the RCT will be disseminated via peer-reviewed publications, conference presentations, and advocacy and stakeholder groups. Exploratory analyses, including potential mediators and moderators, will be reported separately from main outcomes.Trial registration numberClinicalTrials.gov Registry (NCT04621643); Pre-results.

scholarly journals A randomised controlled trial to investigate the effectiveness of sustained photoprotective behaviour in xeroderma pigmentosum after intervention

BJPsych Open ◽  
2021 ◽  
Vol 7 (S1) ◽  
pp. S287-S287
Author(s):  
Tamara Searle ◽  
Jessica Walburn ◽  
Sam Norton
Keyword(s):  
Randomised Controlled Trial ◽  
Self Efficacy ◽  
Xeroderma Pigmentosum ◽  
Controlled Trial ◽  
Premalignant Lesions ◽  
Mental Wellbeing ◽  
Group Effect ◽  
Post Intervention ◽  
Randomised Controlled

AimsThis study aimed to investigate whether an intervention designed to improve photoprotective behaviours is effective at changing behaviour and whether any change could be maintained.BackgroundXeroderma Pigmentosum (XP) is a rare condition in which patients are at risk of malignancies when exposed to ultra-violet radiation (UVR). Sufferers must take extra precautions to protect themselves from UVR. They must apply sunscreen to exposed skin, wear thick clothing, gloves, and a UVR-protective visor. Treatments include preventative photoprotective measures; the use of sunscreen and protective clothing. Additionally, frequent eye and skin examinations are required and swift removal of any premalignant lesions.MethodIn this randomised controlled trial, 16 participants with XP were given questionnaires at 4 time points; baseline, post-intervention, 5 months and 9 months post-intervention. The intervention involved 7 one-on-one counselling sessions, as well as telephone consultations. Counselling sessions encouraged photoprotection adherence, self-efficacy and discussions of any barriers to improving photoprotective behaviour. This study focused on psychosocial variables, attitudes and photoprotection. Questionnaires included the photoprotection self-efficacy questionnaire, Self-Reported Behavioural Automaticity Index, Short Warwick-Edinburgh Mental Wellbeing Scale, Quality of Life and Brief Photoprotection Adherence Questionnaire.ResultThe intervention was shown to have no significant effect on participants’ questionnaires scores. Univariate ANCOVA revealed a group effect between follow-up 1 (FU1) and follow-up 2 (FU2); η2 = 0.422 for self-efficacy in wearing photoprotective clothing. A group effect was identified from BL to FU1 and FU1 to FU2; η2 = 0.343 and η2 = 0.378 respectively in how often participants reapplied sunscreen to their face when outside for longer periods. Univariate ANCOVA revealed no group or time effect for the other outcome variables; for example, sunscreen self-efficacy.ConclusionThe intervention had no significant effect on photoprotective behaviour questionnaire scores. Future research could focus on recruiting more participants globally to generate more statistically powered results. Research should focus on producing a maintainable intervention so that any positive change would produce better long-term health outcomes. This study lays the foundations for future XP research, which will be vital to improve understanding and enhance photo protective behaviour.

scholarly journals Lending an Ear: iPeer2Peer plus Teens Taking Charge online self-management to empower adolescents with arthritis in Ireland: protocol for a pilot randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e027952 ◽  
Author(s):  
Siobhan O'Higgins ◽  
Jennifer Stinson ◽  
Sara Ahola Kohut ◽  
Line Caes ◽  
Caroline Heary ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Peer Support ◽  
Qualitative Content Analysis ◽  
Controlled Trial ◽  
Self Management ◽  
Advisory Panel ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Taking Charge ◽  
Randomised Controlled

IntroductionJuvenile idiopathic arthritis (JIA) negatively affects adolescents’ everyday activities. To address the need for innovative, effective, convenient, low-cost psychosocial self-management programmes, we developed an Irish version of Canadian Teens Taking Charge (TTC) and integrated it with Skype-based peer support iPeer2Peer (iP2P).ObjectivesTo explore the feasibility and preliminary outcome impact (effectiveness) of an integrated iP2P and Irish TTC, via three-arm (treatment as usual, TTC and iP2P–TTC) pilot randomised controlled trial (RCT); and determine feasibility and sample size for a full RCT. To ensure active involvement of adolescents with JIA via a Young Person Advisory Panel and examine how participants experienced the study. Finally, to see if TTC and iP2P with TTC reduce costs for families.Methods and analysisRecruitment of 60 families will be ongoing until July 2019, via healthcare professionals and support groups. Analysis will consist of single-blinded (outcome assessment), three-arm pilot RCT, using online questionnaires, with assessments at baseline (T1), after intervention (T2) and 3 months post-intervention (T3). The primary outcomes on feasibility with comparisons of TTC and iP2P–TTC on fidelity, acceptability and satisfaction, engagement and degrees of tailoring. The secondary outcomes will be self-management and self-efficacy and a range of health-related quality-of-life factors, pain indicators and costs.Participants from the intervention groups will be invited to share their perspectives on the process in semistructured interviews. Quantitative data will be analysed using SPSS V.21 and the audio-taped and transcribed qualitative data will be analysed using qualitative content analysis.DisseminationVia journal articles, conference presentations, co-delivered by key stakeholders when possible, launch of accessible, effective and sustainable Internet self-management and peer support for Irish adolescents with JIA.Trial registration numberISRCTN13535901; Pre-results.

scholarly journals Comparison between two types of anaerobic speed endurance training in competitive soccer players

2016 ◽  
Vol 51 (1) ◽  
pp. 183-192 ◽  
Author(s):  
Magni Mohr ◽  
Peter Krustrup
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Soccer Players ◽  
Fatigue Index ◽  
Post Intervention ◽  
Average Speed ◽  
Repeated Sprint ◽  
Competitive Season ◽  
Randomised Controlled ◽  
Level 2

Abstract The purpose of the present study was to examine the effects of additional in-season speed endurance production versus speed endurance maintenance training regimes on performance in competitive male soccer players. In a randomised controlled trial 18 male sub-elite players were exposed to additional speed endurance production (SEP) or speed endurance maintenance (SEM) training (two additional sessions/wk for 4 weeks) during the competitive season. Players performed the Yo-Yo intermittent recovery level 2 test (YYIR2) and a repeated sprint test (RST) pre- and post-intervention. Yo-Yo IR2 performance increased (p<0.001) by 50 ± 8% and 26 ± 5% in SEP and SEM, respectively, with greater (p=0.03) improvement in SEP. RST performance improved by 2.1 ± 0.3% and 1.3 ± 0.4% in SEP and SEM, respectively, while the RST fatigue index decreased (4.4 ± 0.8 to 3.4 ± 0.5%; p<0.04) in SEP only. Peak and average speed during training were higher (p<0.001) in SEP than in SEM (24.5 ± 0.3 vs 19.2 ± 0.3 and 15.5 ± 0.1 km·h-1 vs 9.4 ± 0.1 km·h-1). Additional in-season anaerobic speed endurance production and maintenance training improves high-intensity exercise performance in competitive soccer players with superior effects of speed endurance production training.

scholarly journals Protocol for the RELATE trial: a feasibility and pilot randomised controlled trial of a low-intensity group intervention for young people in care with elevated posttraumatic stress symptoms

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Rachel M. Hiller ◽  
Rebecca S. Davis ◽  
John Devaney ◽  
Sarah L. Halligan ◽  
Richard Meiser-Stedman ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Young People ◽  
Posttraumatic Stress ◽  
Group Intervention ◽  
Social Care ◽  
Controlled Trial ◽  
Good Evidence ◽  
Post Intervention ◽  
Randomised Controlled

Abstract Introduction Young people in out-of-home care have often experienced trauma, such as direct maltreatment or witnessing violence. There is good evidence that rates of mental health difficulties are high in this group, including posttraumatic stress disorder (PTSD), a trauma-specific mental health outcome. There remains less evidence to guide how to effectively address elevated PTSD symptoms (PTSS) in these young people, particularly in ways that are feasible and scalable for stretched social-care and mental health services. Methods and analysis This protocol describes a feasibility study comprising a pilot two-arm randomised controlled trial (RCT). Participants (N = 50) will be randomised to either (a) a group-based trauma-focused programme (Teaching Recovery Techniques), delivered by mental health practitioners both online and in-person, or (b) care-as-usual. Primarily, the trial aims to explore the key feasibility and protocol acceptability questions, including rates of recruitment and retention, as well as the acceptability of the intervention (particularly the online delivery format) to participants and services. In addition, outcomes including PTSS (primary clinical outcome), depression and functioning will be assessed at baseline (pre-randomisation), post-intervention and at a 3-month follow-up. Ethics and dissemination Ethical approval has been received from the Health Research Authority (Wales REC1 Ref 20/WA/0100) and University, with further approval from the host trust and social care site. The results will inform the design of a definitive RCT. Dissemination will include peer-reviewed journal articles reporting the qualitative and quantitative results, as well as presentations at conferences and lay summaries. Trial registration ClinicalTrials.gov, NCT04467320. Registered on 13 July 2020.

scholarly journals INTERSTAARS: Attention training for infants with elevated likelihood of developing ADHD: A proof-of-concept randomised controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Amy Goodwin ◽  
Emily J. H. Jones ◽  
Simona Salomone ◽  
Luke Mason ◽  
Rebecca Holman ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Middle Childhood ◽  
Causal Effect ◽  
Controlled Trial ◽  
Attention Training ◽  
Proof Of Concept ◽  
Degree Relative ◽  
Post Intervention ◽  
Intention To Treat ◽  
Randomised Controlled

AbstractAttention-deficit/hyperactivity disorder (ADHD) is first diagnosed during middle childhood, when patterns of difficulty are often established. Pre-emptive approaches that strengthen developing cognitive systems could offer an alternative to post-diagnostic interventions. This proof-of-concept randomised controlled trial (RCT) tested whether computerised gaze-based attention training is feasible and improves attention in infants liable to develop ADHD. Forty-three 9- to 16-month-old infants with a first-degree relative with ADHD were recruited (11/2015–11/2018) at two UK sites and randomised with minimisation by site and sex to receive 9 weekly sessions of either (a) gaze-contingent attention training (intervention; n = 20); or (b) infant-friendly passive viewing of videos (control, n = 23). Sessions were delivered at home with blinded outcome assessments. The primary outcome was a composite of attention measures jointly analysed via a multivariate ANCOVA with a combined effect size (ES) from coefficients at baseline, midpoint and endpoint (Registration: ISRCTN37683928). Uptake and compliance was good but intention-to-treat analysis showed no significant differences between 20 intervention and 23 control infants on primary (ES −0.4, 95% CI −0.9 to 0.2; Complier-Average-Causal Effect ES −0.6, 95% CI −1.6 to 0.5) or secondary outcomes (behavioural attention). There were no adverse effects on sleep but a small increase in post-intervention session fussiness. Although feasible, there was no support for short-term effects of gaze-based attention training on attention skills in early ADHD. Longer-term outcomes remain to be assessed. The study highlights challenges and opportunities for pre-emptive intervention approaches to the management of ADHD.

scholarly journals Impact of a farmers’ market nutrition coupon programme on diet quality and psychosocial well-being among low-income adults: protocol for a randomised controlled trial and a longitudinal qualitative investigation

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e035143 ◽  
Author(s):  
Michelle L Aktary ◽  
Stephanie Caron-Roy ◽  
Tolulope Sajobi ◽  
Heather O'Hara ◽  
Peter Leblanc ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Research Ethics ◽  
Diet Quality ◽  
Low Income ◽  
Controlled Trial ◽  
Well Being ◽  
Farmers Markets ◽  
Post Intervention ◽  
Farmers Market ◽  
Randomised Controlled

IntroductionLow-income populations have poorer diet quality and lower psychosocial well-being than their higher-income counterparts. These inequities increase the burden of chronic disease in low-income populations. Farmers’ market subsidies may improve diet quality and psychosocial well-being among low-income populations. In Canada, the British Columbia (BC) Farmers’ Market Nutrition Coupon Programme (FMNCP) aims to improve dietary patterns and health among low-income participants by providing coupons to purchase healthy foods from farmers’ markets. This study will assess the impact of the BC FMNCP on the diet quality and psychosocial well-being of low-income adults and explore mechanisms of programme impacts.Methods and analysisIn a parallel group randomised controlled trial, low-income adults will be randomised to an FMNCP intervention (n=132) or a no-intervention control group (n=132). The FMNCP group will receive 16 coupon sheets valued at CAD$21/sheet over 10–15 weeks to purchase fruits, vegetables, dairy, meat/poultry/fish, eggs, nuts and herbs at farmers’ markets and will be invited to participate in nutrition skill-building activities. Overall diet quality (primary outcome), diet quality subscores, mental well-being, sense of community, food insecurity and malnutrition risk (secondary outcomes) will be assessed at baseline, immediately post-intervention and 16 weeks post-intervention. Dietary intake will be assessed using the Automated Self-Administered 24-hour Dietary Recall. Diet quality will be calculated using the Healthy Eating Index-2015. Repeated measures mixed-effect regression will assess differences in outcomes between groups from baseline to 16 weeks post-intervention. Furthermore, 25–30 participants will partake in semi-structured interviews during and 5 weeks after programme completion to explore participants’ experiences with and perceived outcomes from the programme.Ethics and disseminationEthical approval was obtained from the University of Calgary Conjoint Health Research Ethics Board, Rutgers University Ethics and Compliance, and University of Waterloo Office of Research Ethics. Findings will be disseminated through policy briefs, conference presentations and peer-reviewed publications.Trial registration numberNCT03952338.

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