Changes in Physical Activity Associated With a Multicomponent Weight-Loss Randomized Controlled Trial for Youth With Intellectual Disabilities.

Youth with intellectual disabilities engage in low levels of physical activity (PA). An aim of this family-based weight-loss behavioral intervention (FBBI) trial was to increase and sustain PA in these youth. Accelerometry data were available from 21 individuals with intellectual disabilities, age 14-22 years. Each completed the 6-month FBBI, after which 10 completed a 6-month maintenance intervention (FBBI-M), and 11 received no further intervention (FBBI-C). Twenty participated in a further 6-month follow-up. Accelerometry data were analyzed using linear mixed models. During FBBI, mean (SE) moderate to vigorous PA increased by 4.1 (2.5) min/day and light PA by 24.2 (13.5) min/day. Mean (SE) difference in moderate to vigorous PA between participants in FBBI-M and FBBI-C at 18 months was 14.0 (5.1) min/day (p = .005); mean (SE) difference in light PA was 47.4 (27.4) min/day (p = .08). Increasing PA through behavioral intervention is possible in youth with intellectual disabilities.

Divided infrastructure: legal exclusion and water inequality in an urban slum in Mumbai, India.

Inadequate water access is central to the experience of urban inequality across low- and middle-income countries and leads to adverse health and social outcomes. Previous literature on water inequality in Mumbai, India's second largest city, offers diverse explanations for water disparities between and within slums.(1) This study provides new insights on water disparities in Mumbai's slums by evaluating the influence of legal status on water access. We analyzed data from 593 households in Mandala, a slum with legally recognized (notified) and unrecognized (non-notified) neighborhoods. Relative to households in a notified neighborhood, households in a non-notified neighborhood suffered disadvantages in water infrastructure, accessibility, reliability, and spending. Non-notified households used significantly fewer liters per capita per day of water, even after controlling for religion and socioeconomic status. Our findings suggest that legal exclusion may be a central driver of water inequality. Extending legal recognition to excluded slum settlements, neighborhoods, and households could be a powerful intervention for reducing urban water inequality.

Gender and racial/ethnic differences in food selectivity in children with intellectual disabilities.

BACKGROUND: We examined differences in food selectivity by gender and parent race/ethnicity in children with intellectual disabilities. METHOD: A convenience sample of 56 children with intellectual disabilities was analysed. A modified Youth/Adolescent Food Frequency Questionnaire and a 3-day food record were used to measure child food refusal rate and food repertoire, respectively. RESULTS: Boys were about twice as likely to refuse total foods (rate ratio = 2.34, 95%CI = 1.34-4.09) and fruits (rate ratio = 2.03, 95%CI = 1.04-3.95) and 54% more likely to refuse vegetables (rate ratio = 1.54, 95%CI = 0.93-2.54). Children with Hispanic parents were twice as likely to refuse vegetables compared to children with non-Hispanic White parents (rate ratio = 2.00, 95%CI = 1.03-3.90). In analyses stratified by the presence or absence of co-occurring probable autism spectrum disorder, boys had greater food selectivity than girls. CONCLUSIONS: This study expands our understanding of food selectivity in children with intellectual disabilities.

Trial of Minocycline in a Clinically Isolated Syndrome of Multiple Sclerosis.

BACKGROUND: On the basis of encouraging preliminary results, we conducted a randomized, controlled trial to determine whether minocycline reduces the risk of conversion from a first demyelinating event (also known as a clinically isolated syndrome) to multiple sclerosis. METHODS: During the period from January 2009 through July 2013, we randomly assigned participants who had had their first demyelinating symptoms within the previous 180 days to receive either 100 mg of minocycline, administered orally twice daily, or placebo. Administration of minocycline or placebo was continued until a diagnosis of multiple sclerosis was established or until 24 months after randomization, whichever came first. The primary outcome was conversion to multiple sclerosis (diagnosed on the basis of the 2005 McDonald criteria) within 6 months after randomization. Secondary outcomes included conversion to multiple sclerosis within 24 months after randomization and changes on magnetic resonance imaging (MRI) at 6 months and 24 months (change in lesion volume on T2-weighted MRI, cumulative number of new lesions enhanced on T1-weighted MRI ["enhancing lesions"], and cumulative combined number of unique lesions [new enhancing lesions on T1-weighted MRI plus new and newly enlarged lesions on T2-weighted MRI]). RESULTS: A total of 142 eligible participants underwent randomization at 12 Canadian multiple sclerosis clinics; 72 participants were assigned to the minocycline group and 70 to the placebo group. The mean age of the participants was 35.8 years, and 68.3% were women. The unadjusted risk of conversion to multiple sclerosis within 6 months after randomization was 61.0% in the placebo group and 33.4% in the minocycline group, a difference of 27.6 percentage points (95% confidence interval [CI], 11.4 to 43.9; P=0.001). After adjustment for the number of enhancing lesions at baseline, the difference in the risk of conversion to multiple sclerosis within 6 months after randomization was 18.5 percentage points (95% CI, 3.7 to 33.3; P=0.01); the unadjusted risk difference was not significant at the 24-month secondary outcome time point (P=0.06). All secondary MRI outcomes favored minocycline over placebo at 6 months but not at 24 months. Trial withdrawals and adverse events of rash, dizziness, and dental discoloration were more frequent among participants who received minocycline than among those who received placebo. CONCLUSIONS: The risk of conversion from a clinically isolated syndrome to multiple sclerosis was significantly lower with minocycline than with placebo over 6 months but not over 24 months. (Funded by the Multiple Sclerosis Society of Canada; ClinicalTrials.gov number, NCT00666887 .).

Cost-benefit of outcome adjudication in nine randomised stroke trials.

BACKGROUND: Central adjudication of outcomes is common for randomised trials and should control for differential misclassification. However, few studies have estimated the cost of the adjudication process. METHODS: We estimated the cost of adjudicating the primary outcome in nine randomised stroke trials (25,436 participants). The costs included adjudicators' time, direct payments to adjudicators, and co-ordinating centre costs (e.g. uploading cranial scans and general set-up costs). The number of events corrected after adjudication was our measure of benefit. We calculated cost per corrected event for each trial and in total. RESULTS: The primary outcome in all nine trials was either stroke or a composite that included stroke. In total, the adjudication process associated with this primary outcome cost in excess of £100,000 for a third of the trials (3/9). Mean cost per event corrected by adjudication was £2295.10 (SD: £1482.42). CONCLUSIONS: Central adjudication is a time-consuming and potentially costly process. These costs need to be considered when designing a trial and should be evaluated alongside the potential benefits adjudication brings to determine whether they outweigh this expense.

Outcome Assessment by Central Adjudicators Versus Site Investigators in Stroke Trials: A Systematic Review and Meta-Analysis.

Background and Purpose- In randomized stroke trials, central adjudication of a trial's primary outcome is regularly implemented. However, recent evidence questions the importance of central adjudication in randomized trials. The aim of this review was to compare outcomes assessed by central adjudicators with outcomes assessed by site investigators. Methods- We included randomized stroke trials where the primary outcome had undergone an assessment by site investigators and central adjudicators. We searched MEDLINE, EMBASE, CENTRAL (Cochrane Central Register of Controlled Trials), Web of Science, PsycINFO, and Google Scholar for eligible studies. We extracted information about the adjudication process as well as the treatment effect for the primary outcome, assessed both by central adjudicators and by site investigators. We calculated the ratio of these treatment effects so that a ratio of these treatment effects >1 indicated that central adjudication resulted in a more beneficial treatment effect than assessment by the site investigator. A random-effects meta-analysis model was fitted to estimate a pooled effect. Results- Fifteen trials, comprising 69 560 participants, were included. The primary outcomes included were stroke (8/15, 53%), a composite event including stroke (6/15, 40%) and functional outcome after stroke measured on the modified Rankin Scale (1/15, 7%). The majority of site investigators were blind to treatment allocation (9/15, 60%). On average, there was no difference in treatment effect estimates based on data from central adjudicators and site investigators (pooled ratio of these treatment effects=1.02; 95% CI, [0.95-1.09]). Conclusions- We found no evidence that central adjudication of the primary outcome in stroke trials had any impact on trial conclusions. This suggests that potential advantages of central adjudication may not outweigh cost and time disadvantages in stroke studies if the primary purpose of adjudication is to ensure validity of trial findings.

Food selectivity in a diverse sample of young children with and without intellectual disabilities.

Children with developmental concerns are more likely to be referred to feeding clinics for food selectivity than typically developing (TD) children. However, there is limited research on food selectivity in children with intellectual disabilities (ID). Fifty-nine TD children and 56 children with ID ages 3-8 years participated in the Children's Mealtime Study to compare food selectivity, conceptualized as food refusal and narrow food repertoire, among TD children and children with ID. Parents completed a 119-item food frequency questionnaire. Food refusal rate was calculated as the number of foods the child refused of those offered. Food repertoire, comprising the number of unique foods eaten, was determined from a 3-day food record. Compared to TD children, among children with ID the food refusal rate was significantly higher (28.5% vs. 15.7%) and mean food repertoire significantly narrower (20.7 vs. 24.2 unique foods) (p < 0.01). Approximately 10% of children with ID and approximately 4% of TD children reported eating no fruit on any of the three days of food intake recording, and approximately 10% of children with ID compared to approximately 2% of TD children reported no vegetable intake on any of the three days. In further analyses, we examined the two measures of food selectivity among children with both ID and probable autism spectrum disorder (ASD) (by the Autism Spectrum Rating Scale) compared to children with ID only and to TD children. Food selectivity appeared to be primarily attributable to those children who also had a probable diagnosis of ASD. These findings support the need for screening for food selectivity of children with ID, particularly those who also have ASD. Children who exhibit food selectivity should be referred for further evaluation and intervention.

Examining the Impact of Knowledge Translation Interventions on Uptake of Evidence-Based Practices by Care Aides in Continuing Care.

BACKGROUND: Dissemination of evidence-based practices has been a long-standing challenge for healthcare providers and policy makers. Research has increasingly focused on effective knowledge translation (KT) in healthcare settings. AIMS: This study examined the effectiveness of two KT interventions, informal walkabouts and documentation information sessions, in supporting care aide adoption of new evidence-based practices in continuing care. METHODS: The Sustaining Transfers through Affordable Research Translation (START) study examined sustainability of a new practice, the sit-to-stand activity completed with residents in 23 continuing care facilities in Alberta, Canada. At each facility, two informal walkabouts and two documentation information sessions were conducted with care aides during the first 4 months. To assess their effect, uptake of the sit-to-stand activity was compared 4 days prior to and 4 days after each intervention, as well as the entire first and fourth months of the study were compared. Data were analyzed using mixed linear regression models created to estimate the changes in uptake. RESULTS: Data were collected from 227 residents. After controlling for age, sex, dementia, and mobility, a 5.3% (p = .09) increase in uptake of the mobility activity was observed during the day shift and 6.1% (p = .007) increase in uptake of the mobility activity during the evening shift. Site size had a significant effect on the outcome with medium-sized facilities showing a 12.6% (SE = .07) increase over small sites and a 18.2% (SE = .05) increase over large sites. These results suggest that repeated KT interventions and sufficient time are key variables in the successful implementation of new practices. LINKING EVIDENCE TO ACTION: Consideration of time, repetition, and facility-specific variables such as size may generate simple, cost-effective KT interventions in healthcare settings.

Efficacy of a sexual assault resistance program for university women.

BACKGROUND: Young women attending university are at substantial risk for being sexually assaulted, primarily by male acquaintances, but effective strategies to reduce this risk remain elusive. METHODS: We randomly assigned first-year female students at three universities in Canada to the Enhanced Assess, Acknowledge, Act Sexual Assault Resistance program (resistance group) or to a session providing access to brochures on sexual assault, as was common university practice (control group). The resistance program consists of four 3-hour units in which information is provided and skills are taught and practiced, with the goal of being able to assess risk from acquaintances, overcome emotional barriers in acknowledging danger, and engage in effective verbal and physical self-defense. The primary outcome was completed rape, as measured by the Sexual Experiences Survey-Short Form Victimization, during 1 year of follow-up. RESULTS: A total of 451 women were assigned to the resistance group and 442 women to the control group. Of the women assigned to the resistance group, 91% attended at least three of the four units. The 1-year risk of completed rape was significantly lower in the resistance group than in the control group (5.2% vs. 9.8%; relative risk reduction, 46.3% [95% confidence interval, 6.8 to 69.1]; P=0.02). The 1-year risk of attempted rape was also significantly lower in the resistance group (3.4% vs. 9.3%, P<0.001). CONCLUSIONS: A rigorously designed and executed sexual assault resistance program was successful in decreasing the occurrence of rape, attempted rape, and other forms of victimization among first-year university women. (Funded by the Canadian Institutes of Health Research and the University of Windsor; SARE ClinicalTrials.gov number, NCT01338428.).

A prospective cohort study of vitamin D in optic neuritis recovery.

BACKGROUND: Vitamin D sufficiency is associated with better inflammatory outcomes in multiple sclerosis (MS). We hypothesize that it is also associated with better long-term neurodegenerative measures. OBJECTIVES: To show that vitamin D sufficient patients (25-hydroxy vitamin D (25(OH)D) > 80 nmol/L) have better optical coherence tomography (OCT) neuroaxonal measures of ganglion cell layer (GCL) and retinal nerve fiber layer (RNFL) thickness after optic neuritis. METHODS: In this prospective cohort study, acute optic neuritis patients underwent OCT and serum 25(OH)D assessments at baseline and at month 6, with comparisons between vitamin D sufficient and insufficient patients, and men and women. Potential confounding variables were evaluated. RESULTS: Of 49 enrolled, 36 had complete, analyzable data. At baseline, vitamin D insufficiency was associated with greater RNFL thickness (134.3 vs. 95.2 µm; p = 0.003) in affected eyes. At month 6, insufficient patients had greater GCL thinning (GCL inter-eye difference: 14.2 vs. 4.0 µm, p = 0.008). Men had greater RNFL and GCL thinning than women (GCL: 61.2 vs. 69.6 µm, p = 0.036). CONCLUSION: Acutely, in optic neuritis, RNFL thickness is increased with vitamin D insufficiency. Chronically, neuronal, and possibly axonal loss are associated with vitamin D insufficiency and male gender, suggesting vitamin D and female gender may confer neuroprotection in optic neuritis, and possibly, central nervous system (CNS) inflammatory disease.

The High Prevalence of Vitamin D Insufficiency in Cord Blood in Calgary, Alberta (APrON-D Study).

OBJECTIVE: Vitamin D is important in promoting healthy pregnancy and fetal development. We undertook this study to measure 25-hydroxyvitamin D in maternal and cord blood and to identify maternal factors related to vitamin D status in Calgary. METHODS: Blood samples collected at the time of delivery from the Alberta Pregnancy Outcomes and Nutrition study cohort (ApronStudy.ca) participants were processed for plasma and assayed using liquid chromatography mass spectrometry methodology for 25(OH)D3. RESULTS: Ninety-two pairs of maternal and cord blood samples were obtained. The prevalence of 25(OH)D3 insufficiency-25(OH)D3 <75 nmol/L-was 38% and 80% in women and neonates, respectively. Vitamin D supplementation was the only clinical factor associated with 25(OH)D3 sufficiency, and the odds of sufficiency were 3.75 (95% CI 1.00 to 14.07) higher for women and 5.27 (95% CI 1.37 to 20.27) when over 2000 IU/day were used. CONCLUSION: Using liquid chromatography mass spectrometry, we demonstrated a very high prevalence of vitamin D insufficiency in cord blood and that the use of high dose vitamin D was associated with greater odds of sufficiency in pregnant women and cord blood in Alberta.

Sunitinib maintenance therapy after response to docetaxel in metastatic castration resistant prostate cancer (mCRPC).

Background Docetaxel is a standard first-line treatment option for men with metastatic castration resistant prostate cancer (mCRPC). Sunitinib is attractive as a maintenance therapy due to its mechanism of action, oral route of administration, and acceptable toxicity profile. We designed a phase II study of sunitinib in patients with mCRPC who responded to docetaxel. Methods Patients with responding or stable disease at the completion of docetaxel treatment received 50 mg of sunitinib on 4 week on 2 week off cycles. Treatment continued until disease progression (either by RECIST 1.1 criteria or by cancer related symptomatic progression), intolerable toxicity, start of new cancer therapy, withdrawal of consent, or death. The primary endpoint was progression free survival. Secondary endpoints included PSA response rate and safety. Results Twenty-three patients were enrolled and treated. The mean number of prior cycles of docetaxel given was 8.6 (range 4-12). The median number of cycles of sunitinib administered was 4 (range 1-11). Adverse events were generally grade 1-2 with 12 % grade ≥ 3 which were of a type and severity expected for sunitinib. Median PFS was 4.4 months (95 % CI: 1.6-5.1). Most patients had immediate PSA increases without other evidence of disease progression, with the mean increases in PSA over baseline being 197 %, 342 %, and 1437 % in Cycles 1, 2, and 3, respectively. Conclusion Sunitinib was tolerable as maintenance therapy but median PFS was significantly lower than the predefined threshold of 6 months.

Plasma 3-Epi-25-Hydroxycholecalciferol Can Alter the Assessment of Vitamin D Status Using the Current Reference Ranges for Pregnant Women and Their Newborns.

BACKGROUND: Vitamin D is critical for healthy pregnancies and normal fetal development. It is important to accurately ascertain vitamin D status in mothers and their newborns to establish the optimal vitamin D concentration during pregnancy. There are many different metabolites and epimers of vitamin D in peripheral blood and controversy as to the importance of epimers in estimating vitamin D status in maternal and infant health. OBJECTIVES: We undertook this study to measure 25-hydroxyvitamin D metabolites and epimers and their relations in maternal and cord blood and to evaluate the impact of the inclusion of epimers on assessing vitamin D status. METHODS: We performed a substudy in a longitudinal cohort of pregnant women and their infants in Alberta, Canada [APrON (Alberta Pregnancy Outcomes and Nutrition) Study]. Maternal and cord blood plasma collected at the time of newborn delivery was stored at -70°C until testing and assayed for 25-hydroxyergocalciferol [25(OH)D2], 25-hydroxycholecalciferol [25(OH)D3], and 3-epi-25-hydroxycholecalciferol [3-epi-25(OH)D3] by using LC-tandem mass spectrometry. The effect of 3-epi-25(OH)D3 on estimates of vitamin D adequacy was explored by using McNemar's chi-square test at both recommended thresholds of 50 and 75 nmol/L. RESULTS: Ninety-two pairs of maternal and cord blood samples were obtained. 3-Epi-25(OH)D3 was detected in all samples, comprising 6.0% and 7.8% of 25(OH)D3 in maternal and cord blood, respectively. Positive correlations were found between 25(OH)D3 and 3-epi-25(OH)D3 for both maternal and cord blood (maternal blood: r = 0.34, P = 0.01; cord blood: r = 0.44, P = 0.01). In addition, regression analysis showed a significant association between vitamin D supplementation and 3-epi-25(OH)D3 in maternal and cord blood (ß: 0.423; 95% CI: 0.173, 0.672). When 3-epi-25(OH)D3 was not included in plasma vitamin D estimations, 38% of women and 80% of neonates were classified as having an insufficient concentration (<75 nmol/L); however, with 3-epi-25(OH)D3 included, the estimates of insufficiency were significantly lower: 33% and 73% for women and neonates, respectively. CONCLUSIONS: Using LC-MS/MS we showed the presence of 3-epi-25(OH)D3 in all samples of pregnant women and their cord blood, and when the 3-epimer was included in the estimation of status the prevalence of vitamin D insufficiency (<75 nmol/L) was significantly lower. Our data suggest that the high use of dietary supplements in this group of women contributes to 3-epi-25(OH)D3 concentrations in both maternal and cord blood. Further research on the role of the epimers in characterizing vitamin D status in pregnancy and infancy is imperative.

Transobturator tape versus retropubic tension-free vaginal tape for stress urinary incontinence: 5-year safety and effectiveness outcomes following a randomised trial.

INTRODUCTION AND HYPOTHESIS: In a randomised trial comparing transobturator tape (TOT) to retropubic tension-free vaginal tape (TVT) for women with stress urinary incontinence (SUI), vaginal examination at 12 months showed that tapes were palpable for 80.0 % of the TOT group versus 26.7 % of the TVT group. We hypothesized that this difference would lead to more women in the TOT group experiencing vaginal mesh erosion or other serious adverse events compared to women in the TVT group 5 years after surgery. METHODS: All participants were invited to join the follow-up study after being randomised to receive TOT or TVT for SUI. Consenting women had a vaginal examination, a pad test for urinary incontinence (UI) and completed Health-related Quality of Life Questionnaires (HRQOL). Women unable to attend the clinic completed questionnaires only. The primary composite outcome incorporated mesh exposure, urinary retention, repeat incontinence surgery and moderate to severe pelvic pain. Assuming 80 % follow-up, our study would have 67 % power to detect a difference in primary outcome (two-sided 5 % level of significance). Comparisons between groups used chi-square tests and t tests. RESULTS: One hundred and seventy-six (88.4 %) women participated in the 5-year follow-up (83 TOT, 93 TVT). The primary composite outcome occurred in 21.8 % of the TOT and 27.6 % of the TVT groups [difference =-5.8 %, 95 % confidence interval (CI) -18.9 % to 7.3 %, p value 0.39)] Vaginal examination found more women with palpable tapes in the TOT versus the TVT group (48.5 % versus 22.4 %, p value 0.001). There were no other significant differences between groups. CONCLUSIONS: Serious adverse events and tape effectiveness did not differ between groups at 5 years. Palpable tape remains a concern for women who receive TOT for treating SUI.

Sugar-Sweetened Beverage Intake Is Positively Associated with Baseline Triglyceride Concentrations, and Changes in Intake Are Inversely Associated with Changes in HDL Cholesterol over 12 Months in a Multi-Ethnic Sample of Children.

BACKGROUND: Intake of sugar-sweetened beverages (SSBs) is linked to greater cardiometabolic risk in adults. Although longitudinal evidence is sparse among children, SSB intake reduction is targeted to reduce cardiometabolic risk factors in this group. OBJECTIVE: We investigated characteristics associated with consumption of SSBs in a multi-ethnic sample of children/adolescents and measured cross-sectional and longitudinal associations between SSB intake and plasma HDL cholesterol and triglycerides (TGs) over 12 mo. METHODS: In a diverse cohort of children aged 8-15 y, cross-sectional associations (n = 613) between baseline SSB intake and blood lipid concentrations and longitudinal associations (n = 380) between mean SSB intake, changes in SSB intake, and lipid changes over 12 mo were assessed with multivariable linear regression. RESULTS: Greater SSB intake was associated with lower socioeconomic status, higher total energy intake, lower fruit/vegetable intake, and more sedentary time. In cross-sectional analysis, greater SSB intake was associated with higher plasma TG concentrations among consumers (62.4, 65.3, and 71.6 mg/dL in children who consumed >0 but <2, ≥2 but <7, and ≥7 servings/wk, respectively; P-trend: 0.03); plasma HDL cholesterol showed no cross-sectional association. In the longitudinal analysis, mean SSB intake over 12 mo was not associated with lipid changes; however, the 12-mo increase in plasma HDL-cholesterol concentration was greater among children who decreased their intake by ≥1 serving/wk (4.6 ± 0.8 mg/dL) compared with children whose intake stayed the same (2.0 ± 0.8 mg/dL) or increased (1.5 ± 0.8 mg/dL; P = 0.02). CONCLUSIONS: In a multi-ethnic sample of children, intake of SSBs was positively associated with TG concentrations among consumers, and changes in SSB intake were inversely associated with HDL cholesterol concentration changes over 12 mo. Further research in large diverse samples of children is needed to study the public health implications of reducing SSB intake among children of different racial/ethnic groups. The Daily D Health Study was registered at clinicaltrials.gov as NCT01537809.

Great Taste, Less Waste: a cluster-randomized trial using a communications campaign to improve the quality of foods brought from home to school by elementary school children.

OBJECTIVE: Great Taste, Less Waste (GTLW), a communications campaign, capitalized on the synergy between healthy eating and eco-friendly behaviors to motivate children to bring more fruits and vegetables and fewer sugar-sweetened beverages (SSBs) to school. METHODS: A cluster-randomized trial in Eastern Massachusetts elementary schools in 2011-2012 tested the hypothesis that GTLW would improve the quality of foods from home more than a nutrition-only campaign--Foods 2 Choose (F2C)--or control. Lunch and snack items from home were measured at baseline and 7 months later using digital photography. Mixed linear models compared change in mean servings of fruits, vegetables, and SSBs among groups, and change in mean prevalence of packaging type. Change in prevalence of food items of interest was compared among groups using generalized linear models. RESULTS: Five hundred and eighty-two third and fourth graders from 82 classrooms in 12 schools participated. At follow-up, no significant differences were observed between groups in change in mean servings or change in prevalence of items of interest. No packaging differences were observed. CONCLUSION: GTLW was well received, but no significant changes were observed in the quality of food brought to school. Whether classrooms are an effective environment for change remains to be explored. ClinicalTrials.gov identifier: NCT0157384.

Recruitment and retention of urban schoolchildren into a randomized double-blind vitamin D supplementation trial.

BACKGROUND: While rarely used for supplementation trials in the United States, schools present a practical alternative to a clinical setting. PURPOSE: We describe the successful recruitment and retention of urban schoolchildren into a 6-month randomized, double-blind vitamin D3 supplementation trial. METHODS: Boston-area urban schoolchildren, aged 8-15 years, were recruited in 2011-2012 through classroom and auditorium presentations. Informed consent forms in five languages were sent home to parents. Retention methods included regular telephone calls and gift cards for completed study visits. RESULTS: In total, 691 schoolchildren enrolled. Their mean (standard deviation) age was 11.7 (1.4) years; 59% were racial/ethnic minorities and 68% qualified for free or reduced-price school meals. Multi-level, culturally sensitive, creative approaches contributed to success in recruitment and retention. Of 691 participants, 81% completed the 6-month intervention period. Reasons for attrition included missed appointments and fear of a blood draw. More children from households with higher incomes were retained than those from households with lower incomes (85% vs 79%, respectively, P = 0.04). LIMITATIONS: The need for three fasting blood draws over the 6-month supplementation period was a limiting factor in the recruitment and retention of children in this study. CONCLUSION: Recruitment of urban children into a school-based randomized controlled trial represents a feasible approach for a supplementation study. Particular attention to children of lower socioeconomic status may enhance participation and retention when conducting intervention studies among diverse populations.

Impact of a Smarter Lunchroom intervention on food selection and consumption among adolescents and young adults with intellectual and developmental disabilities in a residential school setting.

OBJECTIVE: To assess whether a Smarter Lunchroom intervention based on behavioural economics and adapted for students with intellectual and developmental disabilities would increase the selection and consumption of fruits, vegetables and whole grains, and reduce the selection and consumption of refined grains. DESIGN: The 3-month intervention took place at a residential school between March and June 2012. The evaluation employed a quasi-experimental, pre-post design comparing five matched days of dietary data. Selection and plate waste of foods at lunch were assessed using digital photography. Consumption was estimated from plate waste. SETTING: Massachusetts, USA. SUBJECTS: Students (n 43) aged 11-22 years with intellectual and developmental disabilities attending a residential school. RESULTS: Daily selection of whole grains increased by a mean of 0·44 servings (baseline 1·62 servings, P = 0·005) and refined grains decreased by a mean of 0·33 servings (baseline 0·82 servings, P = 0·005). The daily consumption of fruits increased by a mean of 0·18 servings (baseline 0·39 servings, P = 0·008), whole grains increased by 0·38 servings (baseline 1·44 servings, P = 0·008) and refined grains decreased by a mean of 0·31 servings (baseline 0·68 servings, P = 0·004). Total kilojoules and total gram weight of food selected and consumed were unchanged. Fruit (P = 0·04) and vegetable (P = 0·03) plate waste decreased. CONCLUSIONS: A Smarter Lunchroom intervention significantly increased whole grain selection and consumption, reduced refined grain selection and consumption, increased fruit consumption, and reduced fruit and vegetable plate waste. Nudge approaches may be effective for improving the food selection and consumption habits of adolescents and young adults with intellectual and developmental disabilities.

The (99m)Tc-DTPA urinary clearance method may be preferable to the plasma disappearance method for assessing glomerular filtration rate in diabetic nephropathy.

BACKGROUND: Isotopic glomerular filtration rate (iGFR) measurement is comparable to the inulin method. In this study, we compared urinary and plasma iGFR methodologies in patients with diabetic nephropathy. METHODS: A total of 147 patients from 3 sites in the Diabetic Intervention with Vitamins to Improve Nephropathy (DIVINe) trial provided 213 sets of urine and blood collections, at baseline, 18 and 36 months. RESULTS: The mean (with standard deviation) plasma iGFR of 60.7 (24.9) ml/min/1.73 m(2) compared to urinary iGFR of 52.0 (28.0) ml/min/1.73 m(2) was statistically significant (p value <0.001). Although plasma and urinary iGFRs were highly related (R(2) = 0.86), plasma iGFR increasingly overestimated urinary iGFRs at lower GFRs. In contrast to the cross-sectional analyses, the two measures of iGFR were weakly related (R(2) = 0.32) in regard to patients' change over 18 months of follow-up. CONCLUSION: Plasma iGFR may not be a suitable method for accurately measuring GFR in patients with advancing degrees of chronic kidney disease from diabetic nephropathy.