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Randomized trial of an intensified, multifactorial intervention in patients with advanced-stage diabetic kidney disease: Diabetic Nephropathy Remission and Regression Team Trial in Japan (DNETT-Japan).
Shikata, K, Haneda, M, Ninomiya, T, Koya, D, Suzuki, Y, Suzuki, D, Ishida, H, Akai, H, Tomino, Y, Uzu, T, et al
Journal of diabetes investigation. 2021;(2):207-216
Abstract
AIMS/INTRODUCTION We evaluated the efficacy of multifactorial intensive treatment (IT) on renal outcomes in patients with type 2 diabetes and advanced-stage diabetic kidney disease (DKD). MATERIALS AND METHODS The Diabetic Nephropathy Remission and Regression Team Trial in Japan (DNETT-Japan) is a multicenter, open-label, randomized controlled trial with a 5-year follow-up period. We randomly assigned 164 patients with advanced-stage diabetic kidney disease (urinary albumin-to-creatinine ratio ≥300 mg/g creatinine, serum creatinine level 1.2-2.5 mg/dL in men and 1.0-2.5 mg/dL in women) to receive either IT or conventional treatment. The primary composite outcome was end-stage kidney failure, doubling of serum creatinine or death from any cause, which was assessed in the intention-to-treat population. RESULTS The IT tended to reduce the risk of primary end-points as compared with conventional treatment, but the difference between treatment groups did not reach the statistically significant level (hazard ratio 0.69, 95% confidence interval 0.43-1.11; P = 0.13). Meanwhile, the decrease in serum low-density lipoprotein cholesterol level and the use of statin were significantly associated with the decrease in primary outcome (hazard ratio 1.14; 95% confidence interval 1.05-1.23, P < 0.001 and hazard ratio 0.53, 95% confidence interval 0.28-0.998, P < 0.05, respectively). The incidence of adverse events was not different between treatment groups. CONCLUSIONS The risk of kidney events tended to decrease by IT, although it was not statistically significant. Lipid control using statin was associated with a lower risk of adverse kidney events. Further follow-up study might show the effect of IT in patients with advanced diabetic kidney disease.
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Psychopharmacological Treatment in the RAISE-ETP Study: Outcomes of a Manual and Computer Decision Support System Based Intervention.
Robinson, DG, Schooler, NR, Correll, CU, John, M, Kurian, BT, Marcy, P, Miller, AL, Pipes, R, Trivedi, MH, Kane, JM
The American journal of psychiatry. 2018;(2):169-179
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OBJECTIVE The Recovery After an Initial Schizophrenia Episode-Early Treatment Program compared NAVIGATE, a comprehensive program for first-episode psychosis, to clinician-choice community care over 2 years. Quality of life and psychotic and depressive symptom outcomes were found to be better with NAVIGATE. Compared with previous comprehensive first-episode psychosis interventions, NAVIGATE medication treatment included unique elements of detailed first-episode-specific psychotropic medication guidelines and a computerized decision support system to facilitate shared decision making regarding prescriptions. In the present study, the authors compared NAVIGATE and community care on the psychotropic medications prescribed, side effects experienced, metabolic outcomes, and scores on the Adherence Estimator scale, which assesses beliefs related to nonadherence. METHOD Prescription data were obtained monthly. At baseline and at 3, 6, 12, 18, and 24 months, participants reported whether they were experiencing any of 21 common antipsychotic side effects, vital signs were obtained, fasting blood samples were collected, and the Adherence Estimator scale was completed. RESULTS Over the 2-year study period, compared with the 181 community care participants, the 223 NAVIGATE participants had more medication visits, were more likely to receive a prescription for an antipsychotic and more likely to receive one conforming to NAVIGATE prescribing principles, and were less likely to receive a prescription for an antidepressant. NAVIGATE participants experienced fewer side effects and gained less weight; other vital signs and cardiometabolic laboratory findings did not differ between groups. Adherence Estimator scores improved in the NAVIGATE group but not in the community care group. CONCLUSIONS As part of comprehensive care services, medication prescription can be optimized for first-episode psychosis, contributing to better outcomes with a lower side effect burden than standard care.
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Prediabetes in pregnancy, can early intervention improve outcomes? A feasibility study for a parallel randomised clinical trial.
Hughes, RCE, Rowan, J, Williman, J
BMJ open. 2018;(3):e018493
Abstract
OBJECTIVE Measurement of glycated haemoglobin (HbA1c) in early pregnancy is routine in New Zealand to identify women with diabetes and prediabetes. However, the benefit of early intervention in women with prediabetes is inconclusive. Our aim was to test the feasibility of a two-arm parallel randomised controlled trial of standard care versus early intervention in pregnancies complicated by prediabetes. SETTING Two tertiary referral centres in New Zealand. PARTICIPANTS Women <14 weeks' gestation and HbA1c ≥5.9%-6.4% (41-46 mmol/mol) measured at booking, without pre-existing diabetes. INTERVENTIONS Randomisation was done by remote web-based allocation into one of two groups. Women in the early intervention group attended an antenatal diabetes clinic, commenced daily home blood glucose monitoring, and medication was prescribed if lifestyle measures failed to maintain target blood glucose levels. Controls received lifestyle education, continued standard care with their midwife and/or obstetrician, and were asked to perform a 75 g oral glucose tolerance test at 24 weeks' gestation with a referral to clinic if this test was positive. Both groups received lifestyle questionnaires at recruitment and in late pregnancy. OUTCOME MEASURES Recruitment rate, adherence to protocol and validation of potential primary outcomes. RESULTS Recruitment rates were lower than expected, especially in Māori and Pacific women. Non-adherence to allocated treatment protocol was significant, 42% (95% CI 24% to 61%) in the early intervention group and 30% (95% CI 16% to 51%) in controls. Caesarean section and pre-eclampsia were signalled as potential primary outcomes, due to both the high observed incidence in the control group and ease of measurement. CONCLUSIONS For a future definitive trial, extending the gestation of eligibility and stepped-wedge cluster randomisation may overcome the identified feasibility issues. Consistent with published observational data, pre-eclampsia and emergency caesarean section could be included as primary outcome measures, both of which have a significant impact on maternal and neonatal morbidity and healthcare costs. TRIAL REGISTRATION NUMBER ACTRN12615000904572; Pre-results.
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Feasibility of initiating early enteral nutrition after congenital heart surgery in neonates and infants.
Kalra, R, Vohra, R, Negi, M, Joshi, R, Aggarwal, N, Aggarwal, M, Joshi, R
Clinical nutrition ESPEN. 2018;:100-102
Abstract
OBJECTIVE To assess the feasibility of initiating enteral nutrition support with first 24 h of congenital heart repairs in neonates and Infants and its impact on outcomes following surgery. DESIGN It is a prospective randomized control single blind study. SETTING It is a single centre prospective study carried out in a tertiary care centre at Pediatric cardiac intensive care unit. PATIENTS All patients with the cyanotic congenital heart disease with increase pulmonary blood flow, weighing less than 5 kg and undergoing congenital heart repair during the study period were included in the study. Patients with single ventricle status, those undergoing palliative procedures (PA band), open chest, requiring ECMO before leaving operating room, having any other contraindication for starting enteral feeding or those who refuse for consent were excluded from study. INTERVENTIONS The patients were randomized into two groups. Group 1 received trophic feeds (10-20 ml/kg/day) starting 4-6 h after surgery while feeds children in group 2 were kept NPO and received feeds after 48 h after surgery. MEASUREMENTS AND MAIN RESULTS 15 children enrolled in both the groups. Both pre-operative and intraoperative variables were comparable in both the groups. There was no complication (vomiting, diarrhea, NEC, bowel necrosis) noted in the children who received feeds after surgery. Mean duration of mechanical ventilation in the feeds group was 58.2 ± 4.71 h, which was less then significantly less than those in the NPO group (P value 0.05). Similarly, duration of ICU stay was only 179.04 ± 41.28 h in feeds group as compared to 228.72 ± 85.44 h in the NPO group. CONCLUSIONS Neonates and Infants tolerate feeds immediately following congenital heart repairs. Moreover, feeds appear to decrease duration of mechanical ventilation and duration of ICU stay.
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Results of the Sedentary Intervention Trial in Cardiac Rehabilitation (SIT-CR Study): A pilot randomized controlled trial.
Prince, SA, Reed, JL, Cotie, LM, Harris, J, Pipe, AL, Reid, RD
International journal of cardiology. 2018;:317-324
Abstract
BACKGROUND Sedentary time (ST) is negatively associated with cardiometabolic health and fitness. Traditional cardiac rehabilitation (CR) programming may not significantly reduce ST. The objectives of the study were to assess the feasibility and practicality of activPAL devices for measuring ST in CR, and whether prompting cues to interrupt sedentary behaviour can decrease ST and improve clinical outcomes. METHODS An 8-week, two-arm pilot randomized controlled trial allocated coronary artery disease patients to either a control (usual care CR) or intervention (CR + sedentary prompts from an activPAL3-VT) group. Primary outcomes included: recruitment; acceptability; completion; and, adherence rates. Secondary outcomes included changes in: ST; physical activity (PA); cardiometabolic health; psychosocial health; and, fitness. RESULTS Forty participants (16 females; 19 intervention; 62 ± 10 years) were randomized. Outcome data were available for 95% of participants. All but one participant completed the full intervention. Most (73%) intervention participants felt the prompts had somewhat changed their sedentary behaviour. At baseline, participants spent 47% of their day sedentary. No significant group differences in changes for any of the ST, PA or fitness outcomes were observed. The mean group difference for post-intervention ST (controlling for baseline) was 30.3 min/day (95% CI: -51.7, 112.2) in favour of the intervention. The intervention group reported significantly better physical health and had a lower ratio of total cholesterol-to-high density lipoprotein when compared to controls. CONCLUSIONS It is feasible to use activPAL devices to measure ST in a CR setting. Further studies are needed to assess the effectiveness of multi-component sedentary behaviour interventions.
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Randomized Controlled Trial of an Educational Intervention Using an Online Risk Calculator for Knee Osteoarthritis: Effect on Risk Perception.
Losina, E, Michl, GL, Smith, KC, Katz, JN
Arthritis care & research. 2017;(8):1164-1170
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OBJECTIVE Young adults, in general, are not aware of their risk of knee osteoarthritis (OA). Understanding risk and risk factors is critical to knee OA prevention. We tested the efficacy of a personalized risk calculator on accuracy of knee OA risk perception and willingness to change behaviors associated with knee OA risk factors. METHODS We conducted a randomized controlled trial of 375 subjects recruited using Amazon Mechanical Turk. Subjects were randomized to either use a personalized risk calculator based on demographic and risk-factor information (intervention), or to view general OA risk information (control). At baseline and after the intervention, subjects estimated their 10-year and lifetime risk of knee OA and responded to contemplation ladders measuring willingness to change diet, exercise, or weight-control behaviors. RESULTS Subjects in both arms had an estimated 3.6% 10-year and 25.3% lifetime chance of developing symptomatic knee OA. Both arms greatly overestimated knee OA risk at baseline, estimating a 10-year risk of 26.1% and a lifetime risk of 47.8%. After the intervention, risk calculator subjects' perceived 10-year risk decreased by 12.9 percentage points to 12.5% and perceived lifetime risk decreased by 19.5 percentage points to 28.1%. Control subjects' perceived risks remained unchanged. Risk calculator subjects were more likely to move to an action stage on the exercise contemplation ladder (relative risk 2.1). There was no difference between the groups for diet or weight-control ladders. CONCLUSION The risk calculator is a useful intervention for knee OA education and may motivate some exercise-related behavioral change.
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Using Sleep Interventions to Engage and Treat Heavy-Drinking College Students: A Randomized Pilot Study.
Fucito, LM, DeMartini, KS, Hanrahan, TH, Yaggi, HK, Heffern, C, Redeker, NS
Alcoholism, clinical and experimental research. 2017;(4):798-809
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BACKGROUND Continued high alcohol consumption levels by college students highlight the need for more effective alcohol interventions and novel treatment engagement strategies. The purpose of this study was to investigate a behavioral sleep intervention as a means to engage heavy-drinking college students in treatment and reduce alcohol use and alcohol-related consequences. METHODS Heavy-drinking college students (N = 42) were assigned to 1 of 2 web-based interventions comprised of 4 modules delivered over 4 weeks. The experimental intervention focused primarily on sleep and included evidence-based sleep content (i.e., stimulus control instructions, sleep scheduling [consistent bed/rise times; ideal sleep duration for adolescents/young adults], sleep hygiene advice, relaxation training, cognitive strategies to target sleep-disruptive beliefs), and alcohol content (i.e., normative and blood alcohol level feedback, moderate drinking guidelines, controlled drinking strategies, effects of alcohol on sleep and the body, advice to moderate drinking for improved sleep) in young adults. The control condition Healthy Behaviors provided basic advice about nutrition, exercise, sleep (i.e., good sleep hygiene only), and drinking (i.e., effects of alcohol on the body, moderate drinking guidelines, advice to moderate drinking for sleep). Participants in both conditions monitored their sleep using daily web-based diaries and a wrist-worn sleep tracker. RESULTS Recruitment ads targeting college students with sleep concerns effectively identified heavy-drinking students. The program generated a high number of inquiries and treatment completion rates were high. Both interventions significantly reduced typical week drinking and alcohol-related consequences and improved sleep quality and sleep-related impairment ratings. The control condition yielded greater reductions in total drinks in a heaviest drinking week. The effects on drinking were larger than those observed in typical brief alcohol intervention studies for college students. Greater sleep improvement tended to predict better subsequent drinking outcomes. CONCLUSIONS The results suggest that sleep treatment may be a promising strategy for targeting and treating heavy-drinking college students.
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Improving early childhood care and development, HIV-testing, treatment and support, and nutrition in Mokhotlong, Lesotho: study protocol for a cluster randomized controlled trial.
Tomlinson, M, Skeen, S, Marlow, M, Cluver, L, Cooper, P, Murray, L, Mofokeng, S, Morley, N, Makhetha, M, Gordon, S, et al
Trials. 2016;(1):538
Abstract
BACKGROUND Since 1990, the lives of 48 million children under the age of 5 years have been saved because of increased investments in reducing child mortality. However, despite these unprecedented gains, 250 million children younger than 5 years in low- and middle-income countries (LMIC) cannot meet their developmental potential due to poverty, poor health and nutrition, and lack of necessary stimulation and care. Lesotho has high levels of poverty, HIV, and malnutrition, all of which affect child development outcomes. There is a unique opportunity to address these complex issues through the widespread network of informal preschools in rural villages in the country, which provide a setting for inclusive, integrated Early Childhood Care and Development (ECCD) and HIV and nutrition interventions. METHODS We are conducting a cluster randomised controlled trial in Mokhotlong district, Lesotho, to evaluate a newly developed community-based intervention program to integrate HIV-testing and treatment services, ECCD, and nutrition education for caregivers with children aged 1-5 years living in rural villages. Caregivers and their children are randomly assigned by village to intervention or control condition. We select, train, and supervise community health workers recruited to implement the intervention, which consists of nine group-based sessions with caregivers and children over 12 weeks (eight weekly sessions, and a ninth top-up session 1 month later), followed by a locally hosted community health outreach day event. Group-based sessions focus on using early dialogic book-sharing to promote cognitive development and caregiver-child interaction, health-related messages, including motivation for HIV-testing and treatment uptake for young children, and locally appropriate nutrition education. All children aged 1-5 years and their primary caregivers living in study villages are eligible for participation. Caregivers and their children will be interviewed and assessed at baseline, after completion of the intervention, and 12 months post intervention. DISCUSSION This study provides a unique opportunity to assess the potential of an integrated early childhood development intervention to prevent or mitigate developmental delays in children living in a context of extreme poverty and high HIV rates in rural Lesotho. This paper presents the intervention content and research protocol for the study. TRIAL REGISTRATION The Mphatlalatsane: Early Morning Star trial is registered on the International Standard Randomized Controlled Trial Number database, registration number ISRCTN16654287 ; the trial was registered on 3 July 2015.
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The extended Infant Feeding, Activity and Nutrition Trial (InFANT Extend) Program: a cluster-randomized controlled trial of an early intervention to prevent childhood obesity.
Campbell, KJ, Hesketh, KD, McNaughton, SA, Ball, K, McCallum, Z, Lynch, J, Crawford, DA
BMC public health. 2016;:166
Abstract
BACKGROUND Understanding how we can prevent childhood obesity in scalable and sustainable ways is imperative. Early RCT interventions focused on the first two years of life have shown promise however, differences in Body Mass Index between intervention and control groups diminish once the interventions cease. Innovative and cost-effective strategies seeking to continue to support parents to engender appropriate energy balance behaviours in young children need to be explored. METHODS/DESIGN The Infant Feeding Activity and Nutrition Trial (InFANT) Extend Program builds on the early outcomes of the Melbourne InFANT Program. This cluster randomized controlled trial will test the efficacy of an extended (33 versus 15 month) and enhanced (use of web-based materials, and Facebook® engagement), version of the original Melbourne InFANT Program intervention in a new cohort. Outcomes at 36 months of age will be compared against the control group. DISCUSSION This trial will provide important information regarding capacity and opportunities to maximize early childhood intervention effectiveness over the first three years of life. This study continues to build the evidence base regarding the design of cost-effective, scalable interventions to promote protective energy balance behaviors in early childhood, and in turn, promote improved child weight and health across the life course. TRIAL REGISTRATION ACTRN12611000386932. Registered 13 April 2011.
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Early Therapeutic Alliance, Treatment Retention, and 12-Month Outcomes in a Healthy Lifestyles Intervention for People with Psychotic Disorders.
Andrews, M, Baker, AL, Halpin, SA, Lewin, TJ, Richmond, R, Kay-Lambkin, FJ, Filia, SL, Castle, D, Williams, JM, Clark, V, et al
The Journal of nervous and mental disease. 2016;(12):894-902
Abstract
Engaging and retaining individuals with psychotic disorders in psychosocial treatments is difficult. Early therapeutic alliance, treatment retention, and 12-month outcomes were examined in a subsample of smokers with a psychotic disorder (N = 178) participating in a healthy lifestyles study comparing a telephone versus face-to-face delivered intervention. Therapeutic alliance was assessed using the Agnew Relationship Measure; primary outcomes were treatment retention and changes in symptoms and health behaviors. Contrary to expectations, early alliance did not predict treatment retention. However, elements of both client- and therapist-rated alliance predicted some clinical outcomes (e.g., higher confidence in the therapeutic alliance at session 1 predicted improvements in 12-month depression). Some modest interactions between early alliance and intervention condition were also identified (e.g., clients initially with lower self-perceived initiative, or higher therapist-perceived bonding benefited preferentially from the telephone-delivered intervention), highlighting the need to further examine the interplay between therapeutic alliance and treatment modality.