scholarly journals The Contribution of Pro-Vitamin A Biofortified Cassava to Vitamin A Intake in Nigerian Pre-school Children

2021 ◽  
pp. 1-26
Author(s):  
Ibukun Afolami ◽  
Folake Samuel ◽  
Karin Borgonjen-van den Berg ◽  
Martin Mwangi ◽  
Olatundun Kalejaiye ◽  
...  
Keyword(s):  
Vitamin A ◽  
Dietary Intake ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Vitamin A Deficiency ◽  
Controlled Trial ◽  
Potential Contribution ◽  
Randomized Controlled ◽  
Habitual Diet ◽  
To Receive

ABSTRACT Background: Biofortified yellow cassava has been developed to alleviate vitamin A deficiency. We examined the potential contribution of yellow cassava to total Retinol Activity Equivalent (RAE) intake if replacing white by yellow cassava among pre-school Nigerian children. Methods: Dietary intake was assessed as part of a randomized controlled trial. Preschool children (n=176) were randomly assigned to receive either white cassava (WC) or yellow cassava (YC) for 17 weeks. Dietary intake assessments were conducted during the intervention and one month after, when children had resumed their habitual diet. Differences in RAE intake between groups and time points were compared using a linear mixed model regression analysis. Results: During intervention, median RAE intake was 536 µg/day in the YC group and 301 µg/day in the WC group (p<0.0001). YC contributed ˜40% to total RAE intake. Nine percent of children in the YC versus 29% in the WC groups had RAE intake below the Estimated Average Requirement. After intervention, median RAE intake was 300 µg/day and did not differ between intervention groups (p=0.5). The interaction effect of group and time showed a 37% decrease in RAE intake in the YC group after the intervention (Exp(β) = 0.63 [95% CI 0.56, 0.72]). If WC was replaced by YC after intervention, the potential contribution of YC to total RAE intake was estimated to be ˜32%. Conclusions: Yellow cassava increased total RAE intake and showed a substantially lower inadequacy of intake. It is therefore recommended as a good source of provitamin A in cassava-consuming regions.

scholarly journals A Randomized Controlled Trial Evaluating Integrative Psychotherapeutic Group Treatment Compared to Self-Help Groups in Functional Vertigo/Dizziness

2021 ◽  
Vol 10 (10) ◽  
pp. 2215
Author(s):  
Karina Limburg ◽  
Katharina Radziej ◽  
Heribert Sattel ◽  
Peter Henningsen ◽  
Marianne Dieterich ◽  
...  
Keyword(s):  
Group Treatment ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Controlled Trial ◽  
Clinical Psychologist ◽  
Control Group ◽  
Attrition Rates ◽  
Randomized Controlled ◽  
Self Help ◽  
Self Help Groups

We tested the efficacy of an integrative psychotherapeutic group treatment (IPGT) in reducing vertigo/dizziness-related impairment along with depression, anxiety, and somatization by conducting a randomized controlled superiority trial comparing IPGT to self-help groups moderated by a clinical psychologist (SHG). Adult patients with functional vertigo and dizziness symptoms were randomly allocated to either the IPGT or SHG as active control group. Outcomes were assessed at baseline (t0), after treatment lasting 16 weeks (t1), and 12 months after treatment (t2). A total of 81 patients were assigned to IPGT and 78 patients were assigned to SHG. Vertigo-related impairment was reduced in both conditions (IPGT: t0–t1: d = 1.10, t0–t2: d = 1.06; SHG: t0–t1: d = 0.86, t0–t2: d = 1.29), showing the efficiency of both IPGT and SHG. Clinically relevant improvements were also obtained for depression in both groups. Linear mixed model analyses revealed no differences between groups for all outcomes (effect of group for the primary outcome: b = −1.15, SE = 2.13, t = −0.54, p = 0.59). Attrition rates were higher in SHG (52.6%) than in IPGT (28.4%). Both conditions improved primary and secondary outcomes while IPGT was better accepted by patients than SHG. Trial registration: ClinicalTrials.gov, Identifier: NCT02320851.

scholarly journals A Randomized Clinical Trial of Snus Examining the Effect of Complete Versus Partial Cigarette Substitution on Smoking-Related Behaviors, and Biomarkers of Exposure

2019 ◽  
Vol 22 (4) ◽  
pp. 473-481 ◽  
Author(s):  
Ellen Meier ◽  
Bruce R Lindgren ◽  
Amanda Anderson ◽  
Sarah A Reisinger ◽  
Kaila J Norton ◽  
...  
Keyword(s):  
New York ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Controlled Trial ◽  
Partial Substitution ◽  
Randomized Controlled ◽  
Biomarkers Of Exposure ◽  
Wilcoxon Rank Sum Test ◽  
Volatile Organic ◽  
Subsequent Exposure

Abstract Introduction This 8-week multisite, randomized controlled trial of snus examined the differential effects of instructions on (1) snus use, (2) smoking and smoking-related measures, and (3) exposure to tobacco-related constituents. Method US adult daily cigarette smokers (n = 150; 43.3% female; Medianage = 43.5) were recruited from Minneapolis, Minnesota; Columbus and Coshocton, Ohio; and Buffalo, New York. Following a 1-week sampling phase of snus, participants who used at least 7 pouches were randomized to either (1) partial substitution (PS; “use snus as you like with your cigarettes”), (2) complete substitution (CS; “avoid cigarettes”), or (3) usual brand cigarettes (UB). Analyses included between-group analyses (eg, PS vs. CS) using Wilcoxon rank sum test of cigarettes per day and snus pouches per day, and a linear mixed model (biomarkers). Results Compared to the PS and UB groups, smokers assigned to CS reported greater reductions in cigarettes per day (ps &lt; .001), using more snus pouches per day (p = .02), and more smoke-free days (CS median = 14.5, PS and UB medians = 0, p &lt; .001). In addition, results demonstrated reductions in carbon monoxide (p &lt; .001), total nicotine equivalents (p = .02), and four out of five measured volatile organic compounds (ps &lt; .01) over time among the CS group. Exposure to N′-nitrosonornicotine increased by trial end only among the PS group (p &lt; .04). Phenanthrene tetraol increased among all groups by trial end (p = .02) with no difference between groups. Conclusions Instructions to completely switch from cigarettes to snus resulted in the greatest reduction in cigarettes and exposure to harmful constituents. Implications Directly instructing smokers to switch completely to snus, rather than using ad libitum (with no instructions to avoid cigarettes), is necessary for reductions in smoking and subsequent exposure to harmful constituents.

Effect of dalfampridine on information processing speed impairment in multiple sclerosis

Neurology ◽  
2019 ◽  
Vol 93 (8) ◽  
pp. e733-e746 ◽  
Author(s):  
Laura De Giglio ◽  
Francesca De Luca ◽  
Flavia Gurreri ◽  
Ilaria Ferrante ◽  
Luca Prosperini ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Information Processing ◽  
Processing Speed ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Controlled Trial ◽  
Information Processing Speed ◽  
Effective Treatment Option ◽  
Double Blind ◽  
To Receive

ObjectiveTo test a possible benefit of dalfampridine on information processing speed (IPS), a key function for cognitive impairment (CogIm) in multiple sclerosis (MS).MethodsIn this randomized, double-blind, placebo-controlled trial, we included patients with a score on the Symbol Digit Modalities Test (SDMT) under the 10th percentile of the reference value. Patients were randomized in a 2:1 ratio to receive dalfampridine 10 mg or placebo twice daily for 12 weeks. They underwent a comprehensive neuropsychological evaluation at screening (T0), at the end of treatment (T1), and after a 4-week follow-up (T2). The primary endpoint was improvement in SDMT.ResultsOut of 208 patients screened, 120 were randomized to receive either dalfampridine (n = 80) or placebo (n = 40). At T1, the dalfampridine group presented an increase of SDMT scores vs placebo group (mean change 9.9 [95% confidence interval (CI) 8.5–11.4] vs 5.2 [95% CI 2.8–7.6], p = 0.0018; d = 0.60 for raw score; and 0.8 [95% CI 0.6–1] vs 0.3 [95% CI 0.0–0.5], p = 0.0013; d = 0.61 for z scores; by linear mixed model with robust standard error). The improvement was not sustained at T2. A beneficial effect of dalfampridine was observed in the Paced Auditory Serial Addition Test and in cognitive fatigue.ConclusionDalfampridine could be considered as an effective treatment option for IPS impairment in MS.Trial registration2013-002558-64 EU Clinical Trials Register.Classification of evidenceThis study provides Class I evidence that for patients with MS with low scores on the SDMT, dalfampridine improves IPS.

The effect of written information and counselling by an advanced practice nurse on resilience in women with vulvar neoplasia during six months after surgical treatment and the influence of social support, recurrence, and age: A secondary analysis of a multicenter randomized controlled trial, WOMAN-PRO-II

2020 ◽  
Author(s):  
Sabine Kofler ◽  
Andrea Kobleder ◽  
Stefan Ott ◽  
Beate Senn
Keyword(s):  
Randomized Controlled Trial ◽  
Surgical Treatment ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Practice Nurse ◽  
Controlled Trial ◽  
Advanced Practice ◽  
Advanced Practice Nurse ◽  
Randomized Controlled ◽  
Written Information

Abstract Background: Women with vulvar neoplasia often complain about physical and psychological distress after surgical treatment. Lack of information and support can influence resilience. Whether an information-related intervention through an advanced practice nurse supports resilience and which other factors affect resilience in women with vulvar neoplasia has never been investigated. Methods: The aims of this study were (a) to analyse whether counselling based on the WOMAN-PRO II program causes a significant improvement in the resilience scores of women with vulvar neoplasia compared to written information and (b) to identify the potential predictors of resilience. A randomized controlled trial was conducted in women with vulvar neoplasia (n = 49) six months after surgical treatment in four Swiss hospitals and one Austrian hospital. Analyses of resilience and its predictors were performed using a linear mixed model. Results: Thirty-six women (intervention I, n = 8; intervention II, n = 28) completed the randomized controlled trial. In total, 13 women (26.5%) dropped out of the trial. The resilience score did not differ significantly between the two interventions three and six months after randomisation (p = 0.759). Age (b = .04, p = 0.001), social support (b = .28, p = 0.009), counselling time (b = .03, p = 0.018) and local recurrence (b = −.56, p = 0.009) were identified as significant predictors of resilience in the linear mixed model analyses. Conclusion: The results indicate that the WOMAN-PRO II program as single intervention does not cause a significant change in the resilience scores of women with vulvar neoplasia six months after surgery. Predictors that promote or minimise resilience have been identified and should be considered when developing resilience programs for women with vulvar neoplasia. A repetition of the study with a larger sample size is recommended.

scholarly journals Cardiovascular Risk Comparison between Expanded Hemodialysis Using Theranova and Online Hemodiafiltration (CARTOON): A Multicenter Randomized Controlled Trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Yeonhee Lee ◽  
Myoung-jin Jang ◽  
Junseok Jeon ◽  
Jung Eun Lee ◽  
Wooseong Huh ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Controlled Trial ◽  
Rank Test ◽  
Cardiovascular Parameters ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Patient Reported ◽  
Echocardiographic Parameters

AbstractExpanded hemodialysis (HDx) with medium cutoff (MCO) membranes, which remove middle-to-large molecules well, may be a good option to replace online hemodiafiltration (online-HDF). To provide more evidence, this randomized controlled trial compared several cardiovascular parameters between patients undergoing HDx and online-HDF. Eighty patients undergoing thrice-weekly hemodialysis were randomly assigned to receive either HDx with a Theranova membrane (n = 43) or online-HDF (n = 37). The primary endpoints were changes in brachial-ankle pulse wave velocity (baPWV), echocardiographic parameters, and coronary artery calcium (CAC) scores over 1 year, and the secondary endpoints included blood cardiovascular biomarkers, mortality, and patient-reported outcomes. A linear mixed model and log-rank test were used to estimate the group differences. 65 patients had completed the trial. The changes in baPWV and echocardiographic parameters did not differ between the two groups. The CAC scores remained stable in the online-HDF group, whereas an increasing trend was shown in the HDx group (P = 0.012). Other endpoints, including cardiovascular and all-cause mortalities, were similar between the two groups. The changes in cardiovascular parameters did not differ between HDx with an MCO membrane and online-HDF. However, attention may be needed in patients with high CAC scores or scores with an increasing tendency when online-HDF is replaced with HDx with an MCO membrane.

scholarly journals Nudging customers towards healthier food and beverage purchases in a real-life online supermarket: a multi-arm randomized controlled trial

BMC Medicine ◽  
2022 ◽  
Vol 20 (1) ◽  
Author(s):  
Josine M. Stuber ◽  
Jeroen Lakerveld ◽  
Loes W. Kievitsbosch ◽  
Joreintje D. Mackenbach ◽  
Joline W. J. Beulens
Keyword(s):  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Controlled Trial ◽  
Intervention Strategy ◽  
Real Life ◽  
Healthy Food ◽  
Lower Percentage ◽  
Randomized Controlled ◽  
Deprived Areas

Abstract Background Nudging is increasingly used to promote healthy food choices in supermarkets. Ordering groceries online is gaining in popularity and nudging seems efficacious there as well, but is never comprehensively tested in real-life. We evaluated the real-life effectiveness of nudging in an online supermarket on healthy food purchases. Methods We conducted a multi-arm, parallel-group, individually randomized controlled trial in an online supermarket. During 1 month, all customers were randomized to (1) control condition, (2) information nudges, (3) position nudges, and (4) information and position nudges combined. Allocation was concealed and customers were not blinded, but unaware of the intervention. Mean differences between the control condition and the intervention arms in the total percentage of healthy purchases were assessed with a linear mixed model. We tested for effect modification by area-level deprivation. Results Based on sales data from 11,775 shoppers, no overall significant effects were detected. Yet, effects were modified by area-level deprivation (pArm 2 < 0.001). Among shoppers from deprived areas, those allocated to information nudges purchased a 2.4% (95%CI 0.8, 4.0) higher percentage of healthy products compared to controls. No significant differences were observed for position (− 1.3%; 95%CI − 2.8, 0.3) and combined nudges (− 0.1%; 95%CI − 1.7, 1.5). Shoppers from non-deprived areas exposed to information nudges (− 1.6%; 95%CI − 3.2, − 0.1) and the combined nudges (− 2.1%; 95%CI − 3.6, − 0.6), but not position nudges (− 0.9%; 95%CI − 2.4, 0.7), purchased a lower percentage of healthy products. Conclusion Information nudges in an online supermarket can increase healthy product purchases, but only for those living in deprived areas. The adverse effects found on purchasing behaviors for those from non-deprived areas call for further research. Further research should also focus on real-life effects of online healthy food nudging as part of a broader nutrition intervention strategy, and on the equitability of the online nudging intervention within populations. Trial registration Retrospectively registered in the ISRCTN registry at May 21, 2021 (ISRCTN10491616).

scholarly journals Slow Cortical Potential Versus Live Z-score Neurofeedback in Children and Adolescents with ADHD: A Multi-arm Pragmatic Randomized Controlled Trial with Active and Passive Comparators

2021 ◽  
Author(s):  
John Hasslinger ◽  
Sven Bölte ◽  
Ulf Jonsson
Keyword(s):  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Controlled Trial ◽  
Pragmatic Trial ◽  
Cortical Potential ◽  
Future Research ◽  
Z Score ◽  
Slow Cortical Potential ◽  
Randomized Controlled

AbstractNeurofeedback (NF) as a treatment for Attention Deficit Hyperactivity Disorder (ADHD) has been evaluated in several trials, but the specificity and generalizability of effects remain unclear. This four-arm randomized controlled trial evaluated the efficacy of Slow Cortical Potential (SCP; standard NF protocol) and Live Z-score (LZS; non-standard NF protocol) delivered in high-frequency format (five sessions per week during five weeks), compared to Working-memory training (WMT; active comparator) and Treatment-as-usual (TAU; passive comparator). N = 202 children/adolescents aged 9 to 17 years with ADHD participated. The primary outcome measure was multi-report (self-, teacher-, and parent-report) ADHD core symptoms on the Conners-3, assessed at baseline, posttreatment, and 6-months follow-up. Data were analyzed using a linear mixed model. Between-group differences were scarce and did not show a distinct pattern. Superiority of LZS over TAU at endpoint were observed for teacher-rated measures only, while significant differences between SCP and TAU were restricted to posttreatment measurements. Contrary to our expectations, LZS outperformed SCP at endpoint for teacher-rated hyperactivity (-5.37; 95% CI: -10.14 to -0.60; p = .028; d = -.36) and overall ADHD symptoms (-2.20; -4.18 to -0.22; p = .030; d = -.41). There was no indication that either form of NF was superior to WMT. No severe adverse events were reported during the trial, whereas transient stress-related problems were quite frequent. Overall, the results from this pragmatic trial do not provide convincing support for broad implementation of NF in child and adolescent psychiatric services. Future research should try to clarify for whom and under what circumstances NF might be a viable treatment option.

A comparison of the Remote Food Photography Method and the Automated Self-Administered 24-hour Dietary Assessment Tool for measuring full day dietary intake among school-aged children

2021 ◽  
pp. 1-26
Author(s):  
Traci A. Bekelman ◽  
Corby K. Martin ◽  
Susan L. Johnson ◽  
Deborah H. Glueck ◽  
Katherine A. Sauder ◽  
...  
Keyword(s):  
Dietary Intake ◽  
Energy Intake ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Assessment Tool ◽  
Dietary Assessment ◽  
Ease Of Use ◽  
Self Report ◽  
Food Photography ◽  
Photography Method

Abstract The limitations of self-report measures of dietary intake are well known. Novel, technology-based measures of dietary intake may provide a more accurate, less burdensome alternative to existing tools. The first objective of this study was to compare participant burden for two technology-based measures of dietary intake among school-age children: the Automated-Self Administered 24-hour Dietary Assessment Tool-2018 (ASA24-2018) and the Remote Food Photography Method (RFPM). The second objective was to compare reported energy intake for each method to the Estimated Energy Requirement for each child, as a benchmark for actual intake. Forty parent-child dyads participated in 2, 3-day dietary assessments: a parent proxy-reported version of the ASA24 and the RFPM. A parent survey was subsequently administered to compare satisfaction, ease of use and burden with each method. A linear mixed model examined differences in total daily energy intake (TDEI) between assessments, and between each assessment method and the EER. Reported energy intake was 379 kcal higher with the ASA24 than the RFPM (p=0.0002). Reported energy intake with the ASA24 was 231 kcal higher than the EER (p = 0.008). Reported energy intake with the RFPM did not differ significantly from the EER (difference in predicted means = −148 kcal, p = 0.09). Median satisfaction and ease of use scores were 5 out of 6 for both methods. A higher proportion of parents reported that the ASA24 was more time consuming than the RFPM (74.4% vs. 25.6%, p = 0.002). Utilization of both methods is warranted given their high satisfaction among parents.

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