Two-arm Randomised Controlled Trial Research Articles

Protocol for a pilot randomised controlled trial evaluating feasibility and acceptability of cognitive remediation group therapy compared with mutual aid group therapy for people ageing with HIV-associated neurocognitive disorder (HAND) in Toronto, Canada

IntroductionHIV-associated neurocognitive disorder (HAND) may affect 30%–50% of people ageing with HIV. HAND may increase stress and anxiety, and impede coping. Psychosocial group therapy may ameliorate HAND’s symptoms, yet the...

A structured telephone-delivered intervention to reduce problem alcohol use (Ready2Change): study protocol for a parallel group randomised controlled trial

BackgroundCurrent population surveys suggest around 20% of Australians meet diagnostic criteria for an alcohol use disorder. However, only a minority seek professional help due to individual and structural barriers, such as low health literacy, stigma, geography, service operating hours and wait lists. Telephone-delivered interventions are readily accessible and ideally placed to overcome these barriers. We will conduct a randomised controlled trial (RCT) to examine the efficacy of a standalone, structured telephone-delivered intervention to reduce alcohol consumption, problem severity and related psychological distress among individuals with problem alcohol use.Methods/designThis is a single site, parallel group, two-arm superiority RCT. We will recruit 344 participants from across Australia with problem alcohol use. After completing a baseline assessment, participants will be randomly allocated to receive either the Ready2Change (R2C) intervention (n = 172, four to six sessions of structured telephone-delivered intervention, R2C self-help resource, guidelines for alcohol consumption and stress management pamphlets) or the control condition (n = 172, four phone check-ins < 5 min, guidelines for alcohol consumption and stress management pamphlets). Telephone follow-up assessments will occur at 4–6 weeks, 3 months, 6 months and 12 months post-baseline. The primary outcome is the Alcohol Use Disorders Identification Test (AUDIT) score administered at 3 months post-baseline. Secondary outcomes include change in AUDIT score (6 and 12 months post-baseline), change in number of past-month heavy drinking days, psychological distress, health and wellbeing, quality of life, client treatment evaluation and cost effectiveness.DiscussionThis study will be one of the first RCTs conducted internationally to examine the impact of a standalone, structured telephone-delivered intervention to address problem alcohol use and associated psychological morbidity. The proposed intervention is expected to contribute to the health and wellbeing of individuals who are otherwise unlikely to seek treatment through mainstream service models, to reduce the burden on specialist services and primary care providers and to provide an accessible and proportionate response, with resulting cost savings for the health system and broader community.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12618000828224. Pre-registered on 16 May 2018.

Evaluation of a personalised adherence intervention to improve photoprotection in adults with Xeroderma Pigmentosum (XP): protocol for the trial of XPAND

IntroductionPoor adherence to photoprotection for people with xeroderma pigmentosum (XP) can be life-threatening. A randomised controlled trial (RCT) is being conducted to test the efficacy of a personalised adherence intervention...

Smartphone-supported Positive Adjustment Coping Intervention (PACI) for couples undergoing fertility treatment: a randomised controlled trial protocol

IntroductionInfertility generally counts as a profound crisis in the lives of couples and as an emotionally stressful experience. For couples undergoing fertility treatment, this is especially true of the waiting...

Efficacy of a midwife-coordinated, individualized, and specialized maternity care intervention (ChroPreg) in addition to standard care in pregnant women with chronic disease: protocol for a parallel randomized controlled trial

Background and objectivesThe number of women of childbearing age with chronic diseases is rising. Evidence has shown that obstetric complications and poor psychological well-being are more prevalent among this group, in addition to these women reporting experiences of less than satisfactory care. More research is needed to investigate how to best meet the special needs of this group during pregnancy and postpartum. Previous research has shown that care coordination, continuity of care, woman-centered care, and specialized maternity care interventions delivered to women with high-risk pregnancies can improve patient-reported outcomes and pregnancy outcomes and be cost-effective. However, no previous trials have examined the efficacy and cost-effectiveness of such interventions among pregnant women with chronic diseases. This paper describes the protocol of a randomized controlled trial (RCT) of a midwife-coordinated, individualized and specialized maternity care intervention (ChroPreg) as an add-on to standard care for pregnant women with chronic diseases.Methods/designThis two-arm parallel group RCT will be conducted from October 2018 through June 2020 at the Department of Obstetrics, Copenhagen University Hospital, Rigshospitalet, Denmark. Pregnant women with chronic diseases are invited to participate; women will be randomized and allocated 1:1 to the ChroPreg intervention plus standard care or standard care alone. The ChroPreg intervention consists of three main components: (1) coordinated and individualized care, (2) additional ante- and postpartum consultations, and (3) specialized midwives. The primary outcome is length of hospital stay during pregnancy and in the postpartum period, and secondary outcomes are psychological well-being (five-item World Health Organization Well-Being Index, Edinburgh Postnatal Depression Scale, Cambridge Worry Scale), health-related quality of life (12-Item Short Form Health Survey), patient satisfaction (Pregnancy and Childbirth Questionnaire), number of antenatal contacts, and pregnancy and delivery outcomes. Data are collected via patient-administered questionnaires and medical records.DiscussionThis trial is anticipated to contribute to the field of knowledge on which planning of improved antenatal, intra-, and postpartum care for women with chronic disease is founded.Trial registrationClinicalTrials.gov, NCT03511508. Registered April 27, 2018.

The role of point-of-care viral load monitoring in achieving the target of 90% suppression in HIV-infected patients in Nigeria: study protocol for a randomized controlled trial

BackgroundThe Joint United Nations Programme on HIV/AIDS 90–90-90 goal envisions 90% of all people receiving antiretroviral therapy to be virally suppressed by 2020. Implied in that goal is that viral load be quantified for all patients receiving treatment, which is a challenging undertaking given the complexity and high cost of standard-of-care viral load testing methods. Recently developed point-of-care viral load testing devices offer new promise to improve access to viral load testing by bringing the test closer to the patient and also returning results faster, often same-day. While manufactures have evaluated point-of-care assays using reference panels, empiric data examining the impact of the new technology against standard-of-care monitoring in low- and middle-income settings are lacking. Our goal in this trial is to compare a point-of-care to standard-of-care viral load test on impact on various clinical outcomes as well to assess the acceptability and feasibility of using the assay in a resource-limited setting.MethodsUsing a two-arm randomized control trial design, we will enroll 794 patients from two different HIV treatment sites in Nigeria. Patients will be randomized 1:1 for point-of-care or standard-of-care viral load monitoring (397 patients per arm). Following initiation of treatment, viral load will be monitored at patients’ 6- and 12-month follow-up visits using either point-of-care or standard-of-care testing methods, based on trial assignment. The monitoring schedule will follow national treatment guidelines. The primary outcome measure in this trial is proportion of patients with viral suppression at month 12 post-initiation of treatment. The secondary outcome measures encompass acceptability, feasibility, and virologic impact variables.DiscussionThis clinical trial will provide information on the impact of using point-of-care versus standard-of-care viral load testing on patient clinical outcomes; the study will also supply data on the acceptability and feasibility of point-of-care viral load monitoring in a resource-limited setting. If this method of testing is acceptable and feasible, and also superior to standard of care, the results of the trial and the information gathered will inform future scaled implementation and further optimization of the clinic-laboratory network that is critical for monitoring achievement of the 90–90-90 goals.Trial registrationUS National Institutes of Health Clinical Trials.gov: NCT03533868. Date of Registration: 23 May 2018. Protocol Version: 10. Protocol Date: 30 March 2018.

The correlation between baseline score and post-intervention score, and its implications for statistical analysis

BackgroundWhen using a continuous outcome measure in a randomised controlled trial (RCT), the baseline score should be measured in addition to the post-intervention score, and it should be analysed using the appropriate statistical analysis.MethodsWe derive the correlation between the change score and baseline score and show that there is always a correlation (usually negative) between the change score and baseline score. We discuss the following correlations and provide the mathematical derivations in the Appendix:Correlation between change score and baseline scoreCorrelation between change score and post scoreCorrelation between change score and average score.The setting here is a parallel, two-arm RCT, but the method discussed in this paper is applicable for any studies or trials that have a continuous outcome measure; it is not restricted to RCTs.ResultsWe show that using the change score as the outcome measure does not address the problem of regression to the mean, nor does it take account of the baseline imbalance. Whether the outcome is change score or post score, one should always adjust for baseline using analysis of covariance (ANCOVA); otherwise, the estimated treat effect may be biased. We show that these correlations also apply when comparing two measurement methods using Bland-Altman plots.ConclusionsThe correlation between baseline and post-intervention scores can be derived using the variance sum law. We can then use the derived correlation to calculate the required sample size in the design stage. Baseline imbalance may occur in RCTs, and ANCOVA should be used to adjust for baseline in the analysis stage.

Transcatheter, sutureless and conventional aortic-valve replacement: a network meta-analysis of 16,432 patients.

Minimally invasive surgical techniques pose alternatives to conventional surgery for the treatment of aortic stenosis (AS). We present a Bayesian network analysis comparing Valve Academic Research Consortium-2 clinical outcomes between transcatheter aortic valve implantation (TAVI), sutureless (SL-AVR) and conventional aortic valve replacement (CAVR). Electronic searches of databases were conducted and seven two-arm randomized-controlled trials and 25 propensity-score-matched studies comparing clinical outcomes of TAVI, SL-AVR and CAVR for treatment of AS were identified. Bayesian Markov chain Monte Carlo modelling was used to analyze clinical outcomes. The analysis included 16,432 patients who underwent TAVI [7,056], SL-AVR [1,238] or CAVR [8,138]. Compared to CAVR, TAVI and SL-AVR were associated with reduced postoperative major bleeding of 59% (OR 0.41, 95% CI: 0.28-0.59) and 44% (OR 0.56, 95% CI: 0.30-0.99) respectively. TAVI had a 41% reduction in postoperative myocardial infarction (OR 0.59, 95% CI: 0.40-0.86) and SL-AVR had a 40% reduction in postoperative acute kidney injury (AKI) (OR 0.62, 95% CI: 0.42-0.86). Compared to TAVI, CAVR and SL-AVR had a reduction in moderate/severe paravalvular regurgitation of 89% (OR 0.11, 95% CI: 0.07-0.16) and 92% (OR 0.08, 95% CI: 0.03-0.17). CAVR had a 67% decreased postoperative permanent pacemaker (PPM) implantation compared to TAVI (OR 0.33, 95% CI: 0.24-0.45) and a 63% reduction compared to SL-AVR (OR 0.37, 95% CI: 0.22-0.61). There were no differences in 30-day mortality or postoperative stroke between the groups. In selected patients, minimally invasive surgical interventions including TAVI and SL-AVR for severe AS are viable alternatives to conventional surgery. However, TAVI is associated with increased paravalvular regurgitation, whereas TAVI and SL-AVR are associated with increased conduction disturbances compared to CAVR.

Use of patient-reported outcome measures (PROMs) in clinical diabetes consultations: study protocol for the DiaPROM randomised controlled trial pilot study

IntroductionAlthough diabetes distress is found to be associated with decreased glycaemic control among adults with type 1 diabetes, the psychological and emotional impact of living with the condition is often...

Randomized trial protocol of bridge intervention for patients with serious mental illness and cancer.

153 Background: Individuals with serious mental illness (SMI) diagnosed with cancer often have disruptions in treatment, leading to premature mortality compared to patients without SMI. To address such gaps in care, we developed and piloted a collaborative care intervention for patients with SMI and cancer (Bridge). We now propose a randomized controlled trial (RCT) to investigate the impact of the Bridge intervention on disruptions in cancer care for patients with SMI. Methods: We will conduct a two-arm RCT (n = 120) comparing Bridge to enhanced usual care (EUC) for patients with SMI (schizophrenia, bipolar disorder, major depressive disorder) and newly diagnosed breast, lung, gastrointestinal, or head/neck cancer. The 12-week Bridge intervention includes: 1) assessment by a psychiatrist with expertise in oncology at cancer diagnosis, 2) involvement of a case manager to promote self-management and care coordination, 3) collaboration between psychiatry and oncology (e.g., joint visits, developing an integrated treatment plan) to address barriers to care, and 4) availability of study clinicians via phone, text, or in-person for consultation and follow-up with patients, caregivers, and oncology and community mental health clinicians. In the EUC arm, study staff will inform the treating oncologist of the psychiatric diagnosis and notify the patient and oncologist of available psychosocial services at enrollment. Patients will be randomized 1:1 to Bridge or EUC, stratified by presence of a caregiver. Identified caregivers will be co-enrolled, and patients without a caregiver will be eligible. We will utilize verbal consent, link study visits to oncology appointments, and personalize frequency and location (e.g., community, clinic, hospital) of contact with patients and caregivers to decrease burden and promote engagement. The primary outcome is the proportion of patients with disruptions in cancer care within 6 months of enrollment, confirmed by oncologists blinded to study arm. Secondary outcomes include clinician assessment of psychiatric illness severity as well as patient and caregiver reported measures (e.g., depression, engagement in care, treatment satisfaction). Results: N/A. Conclusions: N/A. Clinical trial information: NCT03360695.

A Digital Health App to Assess Decisional Capacity to Provide Informed Consent: Protocol for a Randomized Controlled Trial.

BackgroundAny study with human subjects must have a robust consent process to ensure that participants understand the study and can decide whether they want to be involved. Investigators must determine whether a potential study participant is able to make an informed decision and what modifications or supports are needed to maximize participation in decision making. A variety of approaches have been used to modify consent forms and the consent process to increase the research participants’ decisional capacity. This protocol describes a randomized controlled trial (RCT) of a digital health app to support decision making among individuals contemplating providing consent to participate in a clinical trial.ObjectiveThe objective of this RCT will be to determine if the use of a tablet-based app facilitates greater participation in and satisfaction with the consent process compared with standard practice and identify which individual factors are associated with better response to the decision aid. We hypothesize that the tablet-based version of the consent process will promote more informed decision making, including decisions that are more consistent with individual preferences and values expressed during qualitative data collection.MethodsA two-arm RCT will be conducted in a sample of approximately 100 individuals with fragile X syndrome in their homes across the United States.ResultsData analysis will be completed by late 2018.ConclusionsBy developing and testing a novel consent decision aid, we will have a better understanding of whether and how technological support can optimize the fit between the decisional capacity and the decisional process.Trial RegistrationClinicalTrials.gov NCT02465931; https://clinicaltrials.gov/ct2/show/NCT02465931 (Archived by WebCite at http://www.webcitation.org/72Q3xJQAw)International Registered Report Identifier (IRRID)PRR1-10.2196/10360

Mindfulness Training Reduces Stress At Work: A Randomized Controlled Trial.

Mindfulness-based interventions have been suggested as one way to improve employee well-being in the workplace. Despite these purported benefits, there have been few well-controlled randomized controlled trials (RCTs) evaluating mindfulness training in the workplace. Here we conducted a two-arm RCT at work among employees of a digital marketing firm comparing the efficacy of a high dose six-week mindfulness training to a low dose single-day mindfulness training for improving multiple measures of employee well-being assessed using ecological momentary assessment. High dose mindfulness training reduced both perceived and momentary stress, and buffered employees against worsened affect and decreased coping efficacy compared to low dose mindfulness training. These results provide well-controlled evidence that mindfulness training programs can reduce momentary stress at work, suggesting that more intensive mindfulness training doses (i.e., 6-weeks) may be necessary for improving workplace well-being outcomes. This RCT utilizes a novel experience sampling approach to measure the effects of a mindfulness intervention on employee well-being and considers potential dose-response effects of mindfulness training at work.

GP-OSMOTIC trial protocol: an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice

IntroductionOptimal glycaemia can reduce type 2 diabetes (T2D) complications. Observing retrospective continuous glucose monitoring (r-CGM) patterns may prompt therapeutic changes but evidence for r-CGM use in T2D is limited. We...

An internet-based intervention for adjustment disorder (TAO): study protocol for a randomized controlled trial

BackgroundAdjustment Disorder (AjD) is a common and disabling mental health problem. The lack of research on this disorder has led to the absence of evidence-based interventions for its treatment. Moreover, because the available data indicate that a high percentage of people with mental illness are not treated, it is necessary to develop new ways to provide psychological assistance. The present study describes a Randomized Controlled Trial (RCT) aimed at assessing the effectiveness and acceptance of a linear internet-delivered cognitive-behavioral therapy (ICBT) intervention for AjD.MethodsA two-armed RCT was designed to compare an intervention group to a waiting list control group. Participants from the intervention group will receive TAO, an internet-based program for AjD composed of seven modules. TAO combines CBT and Positive Psychology strategies in order to provide patients with complete support, reducing their clinical symptoms and enhancing their capacity to overcome everyday adversity. Participants will also receive short weekly telephone support. Participants in the control group will be assessed before and after a seven-week waiting period, and then they will be offered the same intervention. Participants will be randomly assigned to one of the 2 groups. Measurements will be taken at five different moments: baseline, post-intervention, and three follow-up periods (3-, 6- and 12-month). BDI-II and BAI will be used as primary outcome measures. Secondary outcomes will be symptoms of AjD, posttraumatic growth, positive and negative affect, and quality of life.DiscussionThe development of ICBT programs like TAO responds to a need for evidence-based interventions that can reach most of the people who need them, reducing the burden and cost of mental disorders. More specifically, TAO targets AjD and will entail a step forward in the treatment of this prevalent but under-researched disorder. Finally, it should be noted that this is the first RCT focusing on an internet-based intervention for AjD in the Spanish population.Trial registrationClinicalTrial.gov: NCT02758418. Trial registration date 2 May 2016.

Thrive With Me: Protocol for a Randomized Controlled Trial to Test a Peer Support Intervention to Improve Antiretroviral Therapy Adherence Among Men Who Have Sex With Men.

BackgroundThe suboptimal rate of viral suppression among persons aged 13 years and older and residing in 37 states and the District of Columbia leaves considerable opportunities for onward transmission and contributes to poor health outcomes. Men who have sex with men (MSM) represent one of the most at-risk groups in the United States. There is a clear and continued need for innovative adherence support programs to optimize viral suppression. To address this gap, we designed and are implementing a randomized controlled trial (RCT) to test the efficacy of the Thrive with Me intervention for MSM living with HIV. Critical components of the protocol are presented.ObjectiveThe aim of this study is to describe the protocol for rigorously testing the efficacy of Thrive with Me to improve antiretroviral therapy (ART) adherence among HIV-positive MSM residing in New York City.MethodsA community advisory board and beta testing were used to obtain feedback from HIV-positive MSM on the overall look and feel of Thrive with Me and problems with navigation to finalize intervention components and content. We will enroll 400 HIV-positive MSM residing in the New York City area into a two-arm prospective RCT and follow them for 17 months. Men in the Thrive with Me experimental intervention arm will have access to Thrive with Me for 5 months. Thrive with Me has three primary components: (1) a private social networking feature; (2) tailored HIV and ART adherence information; and (3) medication reminders, self-monitoring, and reflection. Gamification components include badges and leveling up to increase intrinsic motivation to engage with the intervention. Men randomized to the control condition will view a weekly newsletter for 5 months. The newsletter will be delivered via email and contains information on topics related to HIV with the exception of ART adherence. Study assessments will occur at enrollment and 5, 11, and 17 months post enrollment. The primary study outcome is HIV viral load, which is considered an objective indicator of ART adherence.ResultsParticipant recruitment for the RCT began in October 2016, and the data collection period is anticipated to end in the Fall of 2019.ConclusionsThe efficacy trial of Thrive with Me will help to fill gaps in understanding about the utility of multicomponent, technology-based interventions to improve ART adherence among HIV-positive MSM. Of importance is the ability for the results of the Thrive with Me trial to inform best practices for conducting technology-based interventions that incorporate social media features.Trial RegistrationClinicalTrials.gov NCT02704208; https://clinicaltrials.gov/ct2/show/NCT02704208 (Archived by WebCite at http://www.webcitation.org/6zQ8WPra6)Registered Report identifierRR1-10.2196/10182

Stand Out in Class: restructuring the classroom environment to reduce sedentary behaviour in 9\u201310-year-olds\xa0\u2014\xa0study protocol for a pilot cluster randomised controlled trial

BackgroundSedentary behaviour (sitting) is a highly prevalent negative health behaviour, with individuals of all ages exposed to environments that promote prolonged sitting. Excessive sedentary behaviour adversely affects health in children and adults. As sedentary behaviour tracks from childhood into adulthood, the reduction of sedentary time in young people is key for the prevention of chronic diseases that result from excessive sitting in later life. The sedentary school classroom represents an ideal setting for environmental change, through the provision of sit-stand desks. Whilst the use of sit-stand desks in classrooms demonstrates positive effects in some key outcomes, evidence is currently limited by small samples and/or short intervention durations, with few studies adopting randomised controlled trial (RCT) designs. This paper describes the protocol of a pilot cluster RCT of a sit-stand desk intervention in primary school classrooms.Methods/DesignA two-arm pilot cluster RCT will be conducted in eight primary schools (four intervention, four control) with at least 120 year 5 children (aged 9–10 years). Sit-stand desks will replace six standard desks in the intervention classrooms. Teachers will be encouraged to ensure all pupils are exposed to the sit-stand desks for at least 1 h/day on average using a rotation system. Schools assigned to the control arm will continue with their usual practice, no environmental changes will be made to their classrooms. Measurements will be taken at baseline, before randomisation, and at the end of the schools’ academic year. In this study, the primary outcomes of interest will be school and participant recruitment and attrition, acceptability of the intervention, and acceptability and compliance to the proposed outcome measures (including activPAL-measured school-time and school-day sitting, accelerometer-measured physical activity, adiposity, blood pressure, cognitive function, academic progress, engagement, and behaviour) for inclusion in a definitive trial. A full process evaluation and an exploratory economic evaluation will also be conducted to further inform a definitive trial.DiscussionThe primary output of this study will be acceptability data to inform the development of a definitive cluster RCT designed to examine the efficacy of this intervention on health- and education-related outcomes in UK primary school children.Trial registrationISRCTN12915848 (retrospectively registered, date registered 9 November 2016).

Mobile Link \u2013 a theory-based messaging intervention for improving sexual and reproductive health of female entertainment workers in Cambodia: study protocol of a randomized controlled trial

BackgroundIn Cambodia, HIV prevalence is concentrated in key populations including among female entertainment workers (FEWs) who may engage in direct or indirect sex work. Reaching FEWs with sexual and reproductive health (SRH) services has been difficult because of their hidden and stigmatized nature. Mobile-phone-based interventions may be an effective way to reach this population and connect them with the existing services. This article describes study design and implementation of a randomized controlled trial (RCT) of a mobile health intervention (the Mobile Link) aiming to improve SRH and related outcomes among FEWs in Cambodia.MethodsA two-arm RCT will be used to determine the effectiveness of a mobile-phone-based text/voice messaging intervention. The intervention will be developed through a participatory process. Focus group discussions and in-depth interviews have been conducted to inform and tailor behavior change theory-based text and voice messages. During the implementation phase, 600 FEWs will be recruited and randomly assigned into one of the two arms: (1) a control group and (2) a mobile phone message group (either text messages [SMS] or voice messages [VM], a delivery method chosen by participants). Participants in the control group will also receive a weekly monitoring survey, which will provide real-time information to implementing partners to streamline outreach efforts and be able to quickly identify geographic trends. The primary outcome measures will include self-reported HIV and sexually transmitted infections (STI) testing and treatment, condom use, contraceptive use, and gender-based violence (GBV).DiscussionIf the Mobile Link trial is successful, participants will report an increase in condom use, linkages to screening and treatment for HIV and STI, and contraception use as well as a reduction in GBV. This trial is unique in a number of ways. First, the option of participation mode (SMS or VM) allows participants to choose the message medium that best links them to services. Second, this is the first RCT of a mobile-phone-based behavior change intervention using SMS/VMs to support linkage to SRH services in Cambodia. Lastly, we are working with a hidden, hard-to-reach, and dynamic population with which existing methods of outreach have not been fully successful.Trial registrationClinical trials.gov, NCT03117842. Registered on 31 March 2017.

Fatty fish intake and cognitive function: FINS-KIDS, a randomized controlled trial in preschool children

BackgroundMarine resources including fatty fish are important sources of n-3 long chain polyunsaturated fatty acids (n-3 LC-PUFAs), which are important for brain development. To our knowledge, this is the first randomized controlled trial (RCT) investigating the impact of fatty fish on cognition in preschool children. The purpose of the trial was to investigate whether an increased intake of fatty fish compared to meat improves cognitive function in children 4–6 years old.MethodsThe children (n = 232) in this two-armed RCT, Fish Intervention Studies-KIDS (FINS-KIDS) were recruited from 13 kindergartens in Bergen, Norway. They were randomly assigned to lunch meals with fatty fish (herring/mackerel) or meat (chicken/lamb/beef) three times a week for 16 weeks. The fish and meat were weighed before and after the meals to record the exact consumption (dietary compliance). The primary outcome was cognitive function measured by the Wechsler Preschool and Primary Scale of Intelligence, 3rd edition (WPPSI-III) and fine-motor coordination measured by the 9-Hole Peg Test (9-HPT) at pre- and post-intervention. Biological samples (blood, urine, hair), and questionnaires to the caregivers were included at both time points. Linear mixed effect models with a random intercept for kindergarten were used to analyze changes from pre- to post-intervention in the primary outcome variables.ResultsThere were 218 children included in the trial (105 in the fish, and 113 in the meat group). The children consumed a mean (standard deviation) of 2070 (978) g fish or 2675 (850) g meat from the study meals (p < 0.0001). The fish group had a significant increase of red blood cell n-3 LC-PUFAs. The intervention had no effect on the WPPSI-III scores (mean change total raw score; fish group 17.7, 95% confidence interval (CI) 14.8–20.7 vs meat group 17.8, 95% CI 15.0–20.6, p = 0.97) in the main analyses. In the sub-analyses, adjusting for dietary compliance, the fish group showed a higher improvement on total raw score (20.4, 95% CI 17.5–23.3) compared to the meat group (15.2, 95% CI 12.4–18.0, p = 0.0060); docosahexaenoic acid mediated this effect.ConclusionsThere was no beneficial effect of fatty fish compared to meat on cognitive functioning in the preschool children. When considering dietary compliance, we found a beneficial effect of fatty fish on cognitive scores.Trial registrationClinicalTrials.gov, NCT02331667 December 17, 2014.

An integrative Tai Chi program for patients with breast cancer undergoing cancer therapy: study protocol for a randomized controlled feasibility study

BackgroundBreast cancer patients experience various side effects during cancer therapy, often resulting in reduced quality of life and poor adherence to treatment. A limited range of proven interventions has been developed to target such side effects. While Tai Chi offers benefits for the health and well-being of breast cancer survivors, the effectiveness of Tai Chi across the treatment continuum has not been evaluated. Improved patient education and support has been suggested as a priority for breast cancer care. This pilot study assesses the feasibility of a randomized controlled trial (RCT) to evaluate the effectiveness of “an integrative Tai Chi” (ANITA) program for breast cancer patients undergoing cancer therapy. Methods/designThis is a single-centre, two-arm feasibility RCT. Twenty-four patients with breast cancer who have undergone surgical treatment will be recruited from the Dunedin Hospital (New Zealand) over a 12-month period (from August 2017 to July 2018). Subject to informed consent, patients will be randomized to receive standard cancer treatment alone or standard cancer treatment plus the ANITA program, consisting of peer support, health education, and Tai Chi Ruler exercise. The program runs alongside the patient’s adjuvant cancer therapy, which may include chemotherapy, radiation therapy, antibody treatment, and/or antihormonal therapy. Analysis in this study will focus on process evaluation of participant recruitment, retention, treatment fidelity, acceptability of the program, and occurrence of adverse events. Clinical outcomes (i.e., fatigue, sleep quality, anxiety and depression and quality of life) will be assessed at baseline, and at 12 weeks and 24 weeks post-randomization. DiscussionOutcomes from this study will inform the feasibility and methodology for a future fully-powered RCT. Trial registrationAustralian New Zealand Clinical Trials Registry with the identifier ACTRN12617000975392.

Ultrasound Guidance Does Not Improve the Results of Shock Wave for Plantar Fasciitis or Calcific Achilles Tendinopathy: A Randomized Control Trial.

To establish whether the use of ultrasound to direct shock waves to the area of greater calcification in calcaneal enthesopathies was more effective than the common procedure of directing shock waves to the point where the patient has the most tenderness. Two-armed nonblinded randomized control trial with allocation concealment. The Sports Clinic at Sydney University. Participants 18 years or older with symptomatic plantar fasciitis (PF) (with heel spur) or calcific Achilles tendinopathy (CAT). Seventy-four of 82 cases completed treatment protocol and 6-month follow-up. Patients were randomized to receive either ultrasound-guided (UG) or patient-guided (PG) shock wave at weekly intervals over 3 to 5 weeks. Reduced pain on visual analog scale (VAS) and improved functional score on Maryland Foot Score (MFS) (for PF) or Victorian Institute of Sport Assessment-Achilles (VISA-A) (for CAT). Follow-up was at 6 weeks and 3 and 6 months. Comparative 6-month improvements in MFS for the 47 PF cases were PG +20/100 and UG +14/100 (P = 0.20). Comparative 6-month improvement in VISA-A score for the 27 CAT cases were PG +35/100 and UG +27/100 (P = 0.37). Comparative (combined PF and CAT) 6-month improvement in VAS pain scores for all 38 PG cases were +38/100 with +37/100 for all 36 UG shock wave cases. Although both treatment groups had good clinical outcomes in this study, results for the 2 study groups were almost identical. This study shows that there is no major advantage in the addition of ultrasound for guiding shock waves when treating calcaneal enthesopathies (PF and CAT).