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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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Neuropsychological and Neurophysiological Indicators of General and Food-Specific Impulsivity in Children with Overweight and Obesity: A Pilot Study.
Schmidt, R, Sebert, C, Kösling, C, Grunwald, M, Hilbert, A, Hübner, C, Schäfer, L
Nutrients. 2018;(12)
Abstract
Impulsivity, particularly towards food, is a potential risk factor for increased energy intake and the development and maintenance of obesity in children. However, neuropsychological and neurophysiological indicators of general and food-specific impulsivity and their association with children's weight status are poorly understood. This pilot study examined electroencephalography (EEG) frequency band profiles during eyes-closed and eyes-open resting state in n = 12 children with overweight or obesity versus n = 22 normal-weight controls and their link to child- and parent-reported and experimentally assessed impulsivity of children (e.g., risk-taking behavior, approach-avoidance behavior towards food). The main results indicated that children with overweight/obesity versus normal weight showed significantly increased delta and decreased alpha band activity during eyes-closed resting state. Across the total sample, EEG slow-wave band activity was particularly linked to self- and parent-reported impulsivity and greater risk-taking behavior, but not to approach behavior towards food, after controlling for children's age and weight status. The identification of specific EEG patterns in children with excess weight may provide a new basis for developing neurophysiological diagnostic and treatment approaches for childhood obesity. Future studies with larger samples and longitudinal designs are needed to replicate the present findings and test their stability over time.
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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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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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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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Abstract
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.