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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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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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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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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.
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Effect of Behavioral Intervention on Dilated Fundus Examination Rates in Older African American Individuals With Diabetes Mellitus: A Randomized Clinical Trial.
Weiss, DM, Casten, RJ, Leiby, BE, Hark, LA, Murchison, AP, Johnson, D, Stratford, S, Henderer, J, Rovner, BW, Haller, JA
JAMA ophthalmology. 2015;(9):1005-12
Abstract
IMPORTANCE African American individuals are at high risk of diabetes mellitus and diabetic retinopathy but have suboptimal rates of dilated fundus examinations (DFEs). Early intervention is crucial for the prevention of diabetic retinopathy in this high-risk population. OBJECTIVE To test the efficacy of behavioral activation for diabetic retinopathy prevention on rates of DFEs in older African American individuals with diabetes mellitus. DESIGN, SETTING, AND PARTICIPANTS Masked randomized clinical trial at 2 urban medical centers from October 1, 2010, to May 31, 2014. Participants included 206 African American individuals 65 years and older with diabetes mellitus who had not obtained a DFE in the preceding 12 months. INTERVENTIONS Participants were randomized to either behavioral activation for diabetic retinopathy prevention, a behavioral intervention designed to provide education, facilitate identifying and addressing health care barriers, and promote goal setting to improve rates of DFEs, or supportive therapy, a control condition. MAIN OUTCOMES AND MEASURES The primary outcome was medical documentation of a DFE at 6 months' follow-up. Secondary outcomes included the Risk Perceptions and Risk Knowledge Survey of Diabetes Mellitus, Diabetes Self-Care Inventory, Patient Health Questionnaire 9, and National Eye Institute Vision Function Questionnaire 25 scores and hemoglobin A1c levels. RESULTS More participants in the behavioral activation for diabetic retinopathy prevention group (87.9%) obtained a DFE compared with those in the supportive therapy group (34.1%) by the 6-month follow-up assessment (P < .001). Overall, participants in the behavioral activation for diabetic retinopathy prevention group were 2.5 times more likely to obtain a DFE compared with those in the supportive therapy group (risk ratio = 2.58; 95% CI, 1.91-3.48; P < .001). The intervention had no short-term effect on secondary outcomes of hemoglobin A1c levels, depression, or the Risk Perceptions and Risk Knowledge Survey of Diabetes Mellitus or National Eye Institute Vision Function Questionnaire 25 composite scores; however, both groups had improved adherence to diabetes mellitus self-care behaviors from baseline to 6-month follow-up. CONCLUSIONS AND RELEVANCE Behavioral activation for diabetic retinopathy prevention significantly increased rates of DFEs in older African American individuals with diabetes mellitus. Behavioral interventions may have the potential to positively affect screening for diabetic retinopathy in at-risk populations. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01179555.
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Early Obesity Prevention: A Randomized Trial of a Practice-Based Intervention in 0-24-Month Infants.
Schroeder, N, Rushovich, B, Bartlett, E, Sharma, S, Gittelsohn, J, Caballero, B
Journal of obesity. 2015;:795859
Abstract
OBJECTIVE A pediatric office-based intervention was implemented following a randomized, controlled design, aimed at improving child feeding practices and growth patterns and ultimately reducing risk for overweight and obesity later in life. METHODS Four clinics (232 infants) were randomized to control or intervention (I), the latter delivered by health care provider at each of 7-9 well-baby visits over 2 years, using a previously developed program (Growing Leaps and Bounds) that included verbal, visual, and text advice and information for parents. RESULTS The I group offered significantly less soda (p = 0.006), sweetened tea (p = 0.01), punch (p = 0.02) and/or cow's milk (p = 0.001) to infants and delayed the introduction of drink/food other than breast milk (p < 0.05). Parents in the I group had a higher perceived parental monitoring (p = 0.05) and restriction (p = 0.01) on infant feeding. While the I group exhibited at baseline more adverse socioeconomic indicators than the control group, growth trajectory or body size indices did not significantly differ between groups. CONCLUSIONS Education provided by health care providers in addition to follow-up monthly phone calls may help modify parental behaviors related to child feeding and increase parental sense of responsibility toward child eating behaviors.
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Weight loss success in metabolic syndrome by telephone interventions: results from the SHINE Study.
Weinstock, RS, Trief, PM, Cibula, D, Morin, PC, Delahanty, LM
Journal of general internal medicine. 2013;(12):1620-8
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Abstract
BACKGROUND The Diabetes Prevention Program (DPP) intensive lifestyle intervention resulted in significant weight loss, reducing the development of diabetes, but needs to be adapted to primary care provider (PCP) practices. OBJECTIVES To compare a DPP-translation using individual (IC) vs. conference (CC) calls delivered by PCP staff for the outcome of percent weight loss over 2 years. DESIGN Randomized clinical trial. SETTING Five PCP sites. PARTICIPANTS Obese patients with metabolic syndrome, without diabetes (IC, n = 129; CC, n = 128). INTERVENTION Telephone delivery of the DPP Lifestyle Balance intervention [16-session core curriculum in year 1, 12-session continued telephone contact in year 2 plus telephone coaching sessions (dietitians). MAIN MEASURES Weight (kg), body mass index (BMI), and waist circumference. BASELINE DATA age = 52 years, BMI = 39 kg/m(2), 75 % female, 85 % non-Hispanic White, 13 % non-Hispanic Black, and 48 % annual incomes <$40,000/year. In the intention-to-treat analyses at year 2, mean percent weight loss was -5.6 % (CC, p < 0.001) and -1.8 % (IC, p = 0.046) and was greater for CC than for IC (p = 0.016). At year 2, mean weight loss was 6.2 kg (CC) and 2.2 kg (IC) (p < 0.001). There was similar weight loss at year 1, but between year 1 and year 2 CC participants continued to lose while IC participants regained. At year 2, 52 % and 43 % (CC) and 29 % and 22 % (IC) of participants lost at least 5 % and 7 % of initial weight. BMI also decreased more for CC than IC (-2.1 kg/m(2) vs. -0.8 kg/m(2) p < 0.001). Waist circumference decreased by 3.1 cm (CC) and 2.4 cm (IC) at year 2. Completers (≥9 of 16 sessions; mean 13.3 sessions) lost significantly more weight than non-completers (mean 4.3 sessions). CONCLUSIONS PCP staff delivery of the DPP lifestyle intervention by telephone can be effective in achieving weight loss in obese people with metabolic syndrome. Greater weight loss may be attained with a group telephone intervention.