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Parental support in promoting children's health behaviours and preventing overweight and obesity - a long-term follow-up of the cluster-randomised healthy school start study II trial.
Norman, Å, Zeebari, Z, Nyberg, G, Elinder, LS
BMC pediatrics. 2019;(1):104
Abstract
BACKGROUND Effects of obesity prevention interventions in early childhood are only meaningful if they are sustained over time, but long-term follow-up studies are rare. The school-based cluster-randomised Healthy School Start (HSS) trial aimed at child health promotion and obesity prevention through parental support was carried out in 31 pre-school classes (378 families) in disadvantaged areas in Sweden during 2012-2013. Post-intervention results showed intervention effects on intake of unhealthy foods and drinks, and lower BMI-sds in children with obesity at baseline. This study aimed to evaluate the long-term effectiveness 4 years post-intervention. METHODS Data were collected from 215 children in March-June 2017. Child dietary intake, screen time, and physical activity were measured through parental-proxy questionnaires. Child height and weight were measured by the research group. Group effects were examined using Poisson, linear, logistic, and quantile regression for data on different levels. Analyses were done by intention to treat, per protocol, and sensitivity analyses using multiple imputation. RESULTS No between-group effects on dietary intake, screen time, physical activity, or BMI-sds were found for the entire group at the four-year follow-up. In girls, a significant subgroup-effect was found favouring intervention compared to controls with a lower intake of unhealthy foods, but this was not sustained in the sensitivity analysis. In boys, a significant sub-group effect was found where the boys in the intervention group beyond the 95th percentile had significantly higher BMI-sds compared to boys in the control group. This effect was sustained in the sensitivity analysis. Analyses per protocol showed significant intervention effects regarding a lower intake of unhealthy foods and drinks in the children with a high intervention dose compared to controls. CONCLUSIONS Four years after the intervention, only sub-group effects were found, and it is unlikely that the HSS intervention had clinically meaningful effects on the children. These results suggest that school-based prevention programmes need to be extended for greater long-term effectiveness by e.g. integration into school routine practice. In addition, results showed that children with a high intervention dose had better long-term outcomes compared to controls, which emphasises the need for further work to increase family engagement in interventions. TRIAL REGISTRATION ISRCTN, ISRCTN39690370, retrospectively registered March 1, 2013, http://www.isrctn.com/ISRCTN39690370 .
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Effect of Pycnogenol® on attention-deficit hyperactivity disorder (ADHD): study protocol for a randomised controlled trial.
Verlaet, AA, Ceulemans, B, Verhelst, H, Van West, D, De Bruyne, T, Pieters, L, Savelkoul, HF, Hermans, N
Trials. 2017;(1):145
Abstract
BACKGROUND Methylphenidate (MPH), the first choice medication for attention-deficit hyperactivity disorder (ADHD), is associated with serious adverse effects like arrhythmia. Evidence on the association of ADHD with immune and oxidant-antioxidant imbalances offers potential for antioxidant and/or immunomodulatory nutritional supplements as ADHD therapy. One small randomised trial in ADHD suggests, despite various limitations, therapeutic benefit from Pycnogenol®, a herbal, polyphenol-rich extract. METHODS This phase III trial is a 10-week, randomised, double-blind, placebo and active treatment controlled multicentre trial with three parallel treatment arms to compare the effect of Pycnogenol® to MPH and placebo on the behaviour of 144 paediatric ADHD and attention-deficit disorder (ADD) patients. Evaluations of behaviour (measured by the ADHD-Rating Scale (primary endpoint) and the Social-emotional Questionnaire (SEQ)), immunity (plasma cytokine and antibody levels, white blood cell counts and faecal microbial composition), oxidative stress (erythrocyte glutathione, plasma lipid-soluble vitamins and malondialdehyde and urinary 8-OHdG levels, as well as antioxidant enzyme activity and gene expression), serum zinc and neuropeptide Y level, urinary catecholamines and physical complaints (Physical Complaints Questionnaire) will be performed in week 10 and compared to baseline. Acceptability evaluations will be based on adherence, dropouts and reports of adverse events. Dietary habits will be taken into account. DISCUSSION This trial takes into account comorbid behavioural and physical symptoms, as well as a broad range of innovative immune and oxidative biomarkers, expected to provide fundamental knowledge on ADHD aetiology and therapy. Research on microbiota in ADHD is novel. Moreover, the active control arm is rather unseen in research on nutritional supplements, but of great importance, as patients and parents are often concerned with the side effects of MPH. TRIAL REGISTRATION Clinicaltrials.gov number: NCT02700685 . Registered on 18 January 2016. EudraCT 2016-000215-32 . Registered on 4 October 2016.
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Glutamatergic medication in the treatment of obsessive compulsive disorder (OCD) and autism spectrum disorder (ASD) - study protocol for a randomised controlled trial.
Häge, A, Banaschewski, T, Buitelaar, JK, Dijkhuizen, RM, Franke, B, Lythgoe, DJ, Mechler, K, Williams, SC, Dittmann, RW, ,
Trials. 2016;(1):141
Abstract
BACKGROUND Compulsivity is a cross-disorder trait underlying phenotypically distinct psychiatric disorders that emerge in childhood or adolescence. Despite the effectiveness of serotonergic compounds in the treatment of obsessive-compulsive disorder, treatment-resistant symptoms remaining in 40 to 60 % of patients present a pressing clinical problem. There are currently no medications that effectively treat the core impairments of autism spectrum disorder. There is an urgent need for the development of conceptually novel pharmacological strategies. Agents targeting glutamate neurotransmission, such as memantine, represent promising candidates. This proof-of-concept clinical study will allow pilot-testing of memantine for both clinical effectiveness and tolerability/safety. Memantine is an N-methyl-D-aspartate receptor antagonist, approved for the treatment of Alzheimer's dementia in a number of countries. METHODS/DESIGN This 12-week study has an add-on, randomised, double-blind, placebo-controlled design of treatment with memantine, including an up-titration phase (forced flexible dose design, 5-15 mg/day), in patients aged 6-17 years and 9 months with obsessive-compulsive disorder or autism spectrum disorder. It is planned to include patients with obsessive-compulsive disorder (N = 50) or autism spectrum disorder (N = 50) across four centres in three European countries. Patients will be randomly assigned to memantine or placebo in a 1:1 ratio. Primary objectives are the investigation of the effectiveness of memantine in paediatric patients for improving symptoms of compulsivity (primary outcome measure: total score on the Children's Yale-Brown Obsessive-Compulsive Scale) and to explore its tolerability and safety. Secondary objectives are to explore the effects of memantine at the level of structure, function and biochemistry of the fronto-striatal circuits, and to collect blood for genetic analyses and biomarkers. Tertiary objectives are to explore the role of new candidate genes and pathways for compulsivity by linking genes to clinical phenotypes, response to treatment, neurocognitive test performance, and key structural and functional neuroimaging measures of the fronto-striatal circuits and to explore biomarkers/proteomics for compulsivity traits. DISCUSSION This study is part of the large, translational project TACTICS ( http://www.tactics-project.eu/ ) that is funded by the European Union and investigates the neural, genetic and molecular factors involved in the pathogenesis of compulsivity. Its results will provide clinically relevant solid information on potential new mechanisms and medication treatment in obsessive-compulsive and autism spectrum disorders. TRIAL REGISTRATION EudraCT Number: 2014-003080-38 , date of registration: 14 July 2014.
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Mealtime behavior and diabetes-specific parent functioning in young children with type 1 diabetes.
Monaghan, M, Herbert, LJ, Wang, J, Holmes, C, Cogen, FR, Streisand, R
Health psychology : official journal of the Division of Health Psychology, American Psychological Association. 2015;(8):794-801
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OBJECTIVE Management of meals and mealtime behavior is often challenging for parents of young children with Type 1 diabetes. Parent functioning related to diabetes care may directly affect mealtime behaviors and glycemic control. This study evaluated associations among diabetes-specific parent functioning, parent and child mealtime behaviors, and glycemic control. METHOD Parents of young children with Type 1 diabetes (n = 134) completed self-report measures assessing diabetes-specific functioning (hypoglycemia fear, diabetes self-efficacy, diabetes-related quality of life) and child and parent mealtime behaviors. Hemoglobin A1c and percentage of blood glucose values out of range (<70 mg/dL or >200 mg/dL) over a 30-day period were abstracted from medical charts as indicators of glycemic control. Structural equation modeling was utilized to evaluate predictors and related outcomes of child and parent mealtime behavior. RESULTS The proposed model fit the data very well. More frequent problematic child mealtime behaviors were associated with poorer glycemic control; however, more frequent problematic parent mealtime behaviors were marginally associated with better glycemic control. Poorer diabetes-specific parent functioning was associated with more frequent problematic child and parent mealtime behaviors. CONCLUSIONS Problematic child mealtime behaviors, such as disruptive behavior, present a significant risk for poorer glycemic control. Parents may engage in ineffective mealtime management strategies in an effort to meet glycemic recommendations and avoid hyperglycemia and hypoglycemia. Future research will help to determine whether parents may benefit from specific, developmentally appropriate behavioral strategies to manage meals and snacks and promote optimal diabetes management.
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Designing and implementing a kindergarten-based, family-involved intervention to prevent obesity in early childhood: the ToyBox-study.
Manios, Y, Androutsos, O, Katsarou, C, Iotova, V, Socha, P, Geyer, C, Moreno, L, Koletzko, B, De Bourdeaudhuij, I, ,
Obesity reviews : an official journal of the International Association for the Study of Obesity. 2014;:5-13
Abstract
The development of the ToyBox-intervention was based on the outcomes of the preliminary phase of the ToyBox-study, aiming to identify young children's key behaviours and their determinants related to early childhood obesity. The ToyBox-intervention is a multi-component, kindergarten-based, family-involved intervention with a cluster-randomized design, focusing on the promotion of water consumption, healthy snacking, physical activity and the reduction/ breaking up of sedentary time in preschool children and their families. The intervention was implemented during the academic year 2012-2013 in six European countries: Belgium, Bulgaria, Germany, Greece, Poland and Spain. Standardized protocols, methods, tools and material were used in all countries for the implementation of the intervention, as well as for the process, impact, outcome evaluation and the assessment of its cost-effectiveness. A total sample of 7,056 preschool children and their parents/caregivers, stratified by socioeconomic level, provided data during baseline measurements and participated in the intervention. The results of the ToyBox-study are expected to provide a better insight on behaviours associated with early childhood obesity and their determinants and identify effective strategies for its prevention. The aim of the current paper is to describe the design of the ToyBox-intervention and present the characteristics of the study sample as assessed at baseline, prior to the implementation of the intervention.
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Impact of neonatal growth on IQ and behavior at early school age.
Smithers, LG, Lynch, JW, Yang, S, Dahhou, M, Kramer, MS
Pediatrics. 2013;(1):e53-60
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OBJECTIVES The objective was to examine associations of neonatal weight gain (NWG) and head circumference gain (HCG) with IQ scores and behavior at early school age. METHODS We used data from the Promotion of Breastfeeding Intervention Trial, involving Belarusian infants born full term and weighing ≥2500 g. NWG and HCG were measured as the percentage gain in weight and head circumference over the first 4 weeks relative to birth size. IQ and behavior were measured at 6.5 years of age by using the Wechsler Abbreviated Scales of Intelligence and the Strengths and Difficulties Questionnaire (SDQ), respectively, with SDQ collected from parents and teachers. The associations between the exposures (NWG, HCG) and children's IQ and SDQ were examined by using mixed models to account for clustering of measurements, and adjustment for potentially confounding perinatal and socioeconomic factors. RESULTS Mean NWG was 26% (SD 10%) of birth weight. In fully adjusted models, infants in the highest versus lowest quartile of NWG had 1.5-point (95% confidence interval [CI] 0.8 to 2.2) higher IQ scores (n = 13 840). A weak negative (protective) association between NWG and SDQ total difficulties scores was observed for the teacher-reported (β = -0.39, 95% CI -0.71 to -0.08, n = 12 016), but not the parent-reported (β = -0.12, 95% CI -0.39 to 0.15, n = 13 815), SDQ. Similar associations were observed with HCG and IQ and behavior. CONCLUSIONS Faster gains in weight or head circumference in the 4 weeks after birth may contribute to children's IQ, but reverse causality (brain function affects neonatal growth) cannot be excluded.
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European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder.
Coghill, D, Banaschewski, T, Lecendreux, M, Soutullo, C, Johnson, M, Zuddas, A, Anderson, C, Civil, R, Higgins, N, Lyne, A, et al
European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology. 2013;(10):1208-18
Abstract
This study evaluated the efficacy and safety of lisdexamfetamine dimesylate (LDX) compared with placebo in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) in Europe. Osmotic-release oral system methylphenidate (OROS-MPH) was included as a reference arm. Patients (6-17 years old) with a baseline ADHD Rating Scale version IV (ADHD-RS-IV) total score ≥ 28 were randomized (1:1:1) to dose-optimized LDX (30, 50, or 70 mg/day), OROS-MPH (18, 36, or 54 mg/day) or placebo for 7 weeks. Primary and key secondary efficacy measures were the investigator-rated ADHD-RS-IV and the Clinical Global Impressions-Improvement (CGI-I) rating, respectively. Safety assessments included treatment-emergent adverse events (TEAEs), electrocardiograms, and vital signs. Of 336 patients randomized, 196 completed the study. The difference between LDX and placebo in least squares mean change in ADHD-RS-IV total score from baseline to endpoint was -18.6 (95% confidence interval [CI]: -21.5 to -15.7) (p<0.001; effect size, 1.80). The difference between OROS-MPH and placebo in least squares mean change in ADHD-RS-IV total score from baseline to endpoint was -13.0 (95% CI: -15.9 to -10.2) (p<0.001; effect size, 1.26). The proportions (95% CI) of patients showing improvement (CGI-I of 1 or 2) at endpoint were 78% (70-86), 14% (8-21), and 61% (51-70) for LDX, placebo, and OROS-MPH. The most common TEAEs for LDX were decreased appetite, headache, and insomnia. Mean changes in vital signs were modest and consistent with the known profile of LDX. LDX was effective and generally well tolerated in children and adolescents with ADHD.
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Effect of a vitamin/mineral supplement on children and adults with autism.
Adams, JB, Audhya, T, McDonough-Means, S, Rubin, RA, Quig, D, Geis, E, Gehn, E, Loresto, M, Mitchell, J, Atwood, S, et al
BMC pediatrics. 2011;:111
Abstract
BACKGROUND Vitamin/mineral supplements are among the most commonly used treatments for autism, but the research on their use for treating autism has been limited. METHOD This study is a randomized, double-blind, placebo-controlled three month vitamin/mineral treatment study. The study involved 141 children and adults with autism, and pre and post symptoms of autism were assessed. None of the participants had taken a vitamin/mineral supplement in the two months prior to the start of the study. For a subset of the participants (53 children ages 5-16) pre and post measurements of nutritional and metabolic status were also conducted. RESULTS The vitamin/mineral supplement was generally well-tolerated, and individually titrated to optimum benefit. Levels of many vitamins, minerals, and biomarkers improved/increased showing good compliance and absorption. Statistically significant improvements in metabolic status were many including: total sulfate (+17%, p = 0.001), S-adenosylmethionine (SAM; +6%, p = 0.003), reduced glutathione (+17%, p = 0.0008), ratio of oxidized glutathione to reduced glutathione (GSSG:GSH; -27%, p = 0.002), nitrotyrosine (-29%, p = 0.004), ATP (+25%, p = 0.000001), NADH (+28%, p = 0.0002), and NADPH (+30%, p = 0.001). Most of these metabolic biomarkers improved to normal or near-normal levels.The supplement group had significantly greater improvements than the placebo group on the Parental Global Impressions-Revised (PGI-R, Average Change, p = 0.008), and on the subscores for Hyperactivity (p = 0.003), Tantrumming (p = 0.009), Overall (p = 0.02), and Receptive Language (p = 0.03). For the other three assessment tools the difference between treatment group and placebo group was not statistically significant.Regression analysis revealed that the degree of improvement on the Average Change of the PGI-R was strongly associated with several biomarkers (adj. R2 = 0.61, p < 0.0005) with the initial levels of biotin and vitamin K being the most significant (p < 0.05); both biotin and vitamin K are made by beneficial intestinal flora. CONCLUSIONS Oral vitamin/mineral supplementation is beneficial in improving the nutritional and metabolic status of children with autism, including improvements in methylation, glutathione, oxidative stress, sulfation, ATP, NADH, and NADPH. The supplement group had significantly greater improvements than did the placebo group on the PGI-R Average Change. This suggests that a vitamin/mineral supplement is a reasonable adjunct therapy to consider for most children and adults with autism. CLINICAL TRIAL REGISTRATION NUMBER NCT01225198.
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Effect of chelation therapy on the neuropsychological and behavioral development of lead-exposed children after school entry.
Dietrich, KN, Ware, JH, Salganik, M, Radcliffe, J, Rogan, WJ, Rhoads, GG, Fay, ME, Davoli, CT, Denckla, MB, Bornschein, RL, et al
Pediatrics. 2004;(1):19-26
Abstract
OBJECTIVE Some children in the United States continue to be exposed to levels of lead that increase their risk for lowered intellectual functioning and behavior problems. It is unclear whether chelation therapy can prevent or reverse the neurodevelopmental sequelae of lead toxicity. The objective of this study was to determine whether chelation therapy with succimer (dimercaptosuccinic acid) in children with referral blood lead levels between 20 and 44 microg/dL (0.96-2.12 micromol/L) at 12 to 33 months of age has neurodevelopmental benefits at age 7 years. METHODS The Treatment of Lead-Exposed Children (TLC) study is a randomized, double-blind, placebo-controlled trial that was conducted between September 1994 and June 2003 in Philadelphia, PA; Newark, NJ; Cincinnati, OH; and Baltimore, MD. Of 1854 referred children who were between the ages of 12 to 33 months and screened for eligibility, 780 were randomized to the active drug and placebo groups stratified by clinical center, body surface area, blood lead level, and language spoken at home. At 7 years of age, 647 subjects remained in the study. Participants were randomly assigned to receive oral succimer or placebo. Up to 3 26-day courses of succimer or placebo therapy were administered depending on response to treatment in those who were given active drug. Eighty-nine percent had finished treatment by 6 months, with all children finishing by 13 months after randomization. All participants received residential lead hazard control measures before treatment. TLC subjects also received a daily multivitamin supplement before and after treatment(s) with succimer or placebo. Scores on standardized neuropsychological measures that tap cognition, behavior, learning and memory, attention, and neuromotor skills were measured. RESULTS Chelation therapy with succimer lowered average blood lead levels for approximately 6 months but resulted in no benefit in cognitive, behavioral, and neuromotor endpoints. CONCLUSION These new follow-up data confirm our previous finding that the TLC regimen of chelation therapy is not associated with neurodevelopmental benefits in children with blood lead levels between 20 and 44 microg/dL (0.96-2.17 micromol/L). These results emphasize the importance of taking environmental measures to prevent exposure to lead. Chelation therapy with succimer cannot be recommended for children with blood lead levels between 20 and 44 microg/dL (0.96-2.12 micromol/L).
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The effect of chelation therapy with succimer on neuropsychological development in children exposed to lead.
Rogan, WJ, Dietrich, KN, Ware, JH, Dockery, DW, Salganik, M, Radcliffe, J, Jones, RL, Ragan, NB, Chisolm, JJ, Rhoads, GG, et al
The New England journal of medicine. 2001;(19):1421-6
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BACKGROUND Thousands of children, especially poor children living in deteriorated urban housing, are exposed to enough lead to produce cognitive impairment. It is not known whether treatment to reduce blood lead levels prevents or reduces such impairment. METHODS We enrolled 780 children with blood lead levels of 20 to 44 microg per deciliter (1.0 to 2.1 micromol per liter) in a randomized, placebo-controlled, double-blind trial of up to three 26-day courses of treatment with succimer, a lead chelator that is administered orally. The children lived in deteriorating inner-city housing and were 12 to 33 months of age at enrollment; 77 percent were black, and 5 percent were Hispanic. Follow-up included tests of cognitive, motor, behavioral, and neuropsychological function over a period of 36 months. RESULTS During the first six months of the trial, the mean blood lead level in the children given succimer was 4.5 microg per deciliter (0.2 micromol per liter) lower than the mean level in the children given placebo (95 percent confidence interval, 3.7 to 5.3 microg per deciliter [0.2 to 0.3 micromol per liter]). At 36 months of follow-up, the mean IQ score of children given succimer was 1 point lower than that of children given placebo, and the behavior of children given succimer was slightly worse as rated by a parent. However, the children given succimer scored slightly better on the Developmental Neuropsychological Assessment, a battery of tests designed to measure neuropsychological deficits thought to interfere with learning. All these differences were small, and none were statistically significant. CONCLUSIONS Treatment with succimer lowered blood lead levels but did not improve scores on tests of cognition, behavior, or neuropsychological function in children with blood lead levels below 45 microg per deciliter. Since succimer is as effective as any lead chelator currently available, chelation therapy is not indicated for children with these blood lead levels.