A randomised double-blind placebo-controlled trial investigating the behavioural effects of vitamin, mineral and n-3 fatty acid supplementation in typically developing adolescent schoolchildren

AbstractNutrient deficiencies have been implicated in anti-social behaviour in schoolchildren; hence, correcting them may improve sociability. We therefore tested the effects of vitamin, mineral and n-3 supplementation on behaviour in a 12-week double-blind randomised placebo-controlled trial in typically developing UK adolescents aged 13–16 years (n 196). Changes in erythrocyte n-3 and 6 fatty acids and some mineral and vitamin levels were measured and compared with behavioural changes, using Conners’ teacher ratings and school disciplinary records. At baseline, the children’s PUFA (n-3 and n-6), vitamin and mineral levels were low, but they improved significantly in the group treated with n-3, vitamins and minerals (P=0·0005). On the Conners disruptive behaviour scale, the group given the active supplements improved, whereas the placebo group worsened (F=5·555, d=0·35; P=0·02). The general level of disciplinary infringements was low, thus making it difficult to obtain improvements. However, throughout the school term school disciplinary infringements increased significantly (by 25 %; Bayes factor=115) in both the treated and untreated groups. However, when the subjects were split into high and low baseline infringements, the low subset increased their offences, whereas the high-misbehaviour subset appeared to improve after treatment. But it was not possible to determine whether this was merely a statistical artifact. Thus, when assessed using the validated and standardised Conners teacher tests (but less clearly when using school discipline records in a school where misbehaviour was infrequent), supplementary nutrition might have a protective effect against worsening behaviour.

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Which boys respond to stimulant medication? A controlled trial of methylphenidate in boys with disruptive behaviour

Psychological Medicine ◽

10.1017/s0033291700013039 ◽

1987 ◽

Vol 17 (1) ◽

pp. 121-143 ◽

Cited By ~ 152

Author(s):

E. Taylor ◽

R. Schachar ◽

G. Thorley ◽

H. M. Wieselberg ◽

B. Everitt ◽

...

Keyword(s):

Effective Treatment ◽

Crossover Trial ◽

Stimulant Medication ◽

Psychiatric Treatment ◽

Controlled Trial ◽

Disruptive Behaviour ◽

Double Blind ◽

Double Blind Placebo ◽

Impaired Performance ◽

Younger Age

SynopsisThirty-eight boys, referred for psychiatric treatment because of serious problems of behaviour, underwent a double-blind, placebo-controlled, crossover trial of methylphenidate and placebo. Methylphenidate was an effective treatment over a 3-week period. A good response to methylphenidate was predicted by higher levels of inattentive and restless behaviour, impaired performance on tests of attention, clumsiness, younger age and by the absence of symptoms of overt emotional disorder. DSM-III and ICD-9 diagnoses of ‘hyperactivity’ were not good predictors. The results support the validity of a construct of hyperactivity in describing childhood psychopathology, but emphasize the need for a refinement of diagnostic criteria.

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Pragmatic randomised trial of a smartphone app (NRT2Quit) to improve effectiveness of nicotine replacement therapy in a quit attempt by improving medication adherence - results of a prematurely terminated study

10.21203/rs.2.440/v2 ◽

2019 ◽

Author(s):

Aleksandra Herbec ◽

Jamie Brown ◽

Lion Shahab ◽

Robert West ◽

Tobias Raupach

Keyword(s):

Replacement Therapy ◽

Nicotine Replacement Therapy ◽

Bayes Factor ◽

Controlled Trial ◽

Randomised Trial ◽

Smartphone App ◽

Community Pharmacies ◽

Double Blind ◽

Nicotine Replacement

Abstract Background: Nicotine replacement therapy (NRT) bought over the counter (OTC) appears to be largely ineffective for smoking cessation, which may be partially explained by poor adherence. We developed and evaluated the NRT2Quit smartphone app (for iOS) designed to improve quit attempts with OTC NRT by improving adherence to the medications. Methods: A pragmatic double-blind randomized controlled trial with remote recruitment through leaflets distributed to over 300 UK-based community pharmacies. The study recruited adult daily smokers (≥10 cig/day) who bought NRT, wanted to quit smoking, downloaded NTR2Quit and completed the registration process within the app. Participants were automatically randomized within the app to the intervention (full) version of NRT2Quit or to its control (minimal) versions. The primary outcome was biochemically-verified 4-week abstinence assessed at 8-week follow-up using Russell Standard criteria and intention-to-treat. Bayes factors were calculated for the cessation outcome. Secondary outcomes were self-reported abstinence, NRT use, app use and satisfaction with the app. Results: The study under-recruited with only 41 participants (3.5% of the target sample) randomly assigned to NRT2Quit (n=16) or the control (n=25) app versions between March 2015-September 2016. The follow-up rate was 51.2%. The intervention participants had numerically higher biochemically-verified quit rates (25.0% vs 8.0%, p=0.19, OR=3.83,0.61-24.02). The Bayes factor calculated was 1.92 showed the data were insensitive to test for the hypothesis that the intervention app version aided cessation. The intervention participants had higher median logins (2.5 vs. 0, p=0.01), were more likely to use NRT at follow-up (100.0% vs. 28.6%, p=0.03) and recommend NRT2Quit to others (100.0% vs. 28.6%, p=0.01). Conclusions: Despite very low recruitment there was preliminary but inconclusive evidence that NRT2Quit may improve short-term abstinence and adherence among smokers using nicotine replacement therapy. Well-powered studies on NRT2Quit are needed, but different recruitment methods will be required to engage smokers through community pharmacies or other channels.

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Applying behavioural science to increase uptake of the NHS Health Check: a randomised controlled trial of gain- and loss-framed messaging in the national patient information leaflet

BMC Public Health ◽

10.1186/s12889-019-7754-5 ◽

2019 ◽

Vol 19 (1) ◽

Cited By ~ 1

Author(s):

Natalie Gold ◽

Caroline Durlik ◽

Jet G. Sanders ◽

Katherine Thompson ◽

Tim Chadborn

Keyword(s):

Bayes Factor ◽

Controlled Trial ◽

Random Effect ◽

Health Check ◽

Behavioural Science ◽

Double Blind ◽

Related Condition ◽

Invitation Letter ◽

The Impact ◽

Nhs Health Check

Abstract Background The NHS Health Check (NHSHC) is a national programme for the prevention of non-communicable diseases. Patients aged 40–74 without an existing cardiovascular-related condition should be invited quinquennially. Uptake is lower than anticipated. We assessed the impact on uptake of two new behaviourally-enhanced leaflets (with the current national leaflet as a control), enclosed with the invitation letter: the first trial on the leaflet. Methods A double-blind three-armed randomized controlled trial was conducted. The new leaflets were shorter (two pages, instead of four); one was loss-framed (‘don’t miss out’) and the other was gain-framed (‘make the most of life’). The participants were patients from 39 practices in Lewisham and 17 practices in NE Lincolnshire, who were allocated to interventions using a random-number generator and received one of the leaflets with their invitation letter from April–September 2018. The outcome measure was uptake of an NHSHC by November 2018. The trial was powered to detect a 2% effect. Results Uptake was 17.6% in the control condition (n = 3677), 17.4% in the loss-framed condition (n = 3664), and 18.2% in the gain-framed condition (n = 3697). Leaflet type was not a significant predictor of NHSHC uptake in a logistic regression that controlled for demographic variables, with GP practice as a random effect. Statistically significant predictors of uptake included location (higher uptake in Lewisham), age (increased age was associated with increased attendance) and sex (higher uptake in females). The Bayes Factor comparing the null to a hypothesis of differences between conditions was 416, which is extreme evidence in favour of the null hypothesis. Conclusion There was no evidence for a meaningful effect of either a loss-framed or gain-framed behaviourally-informed leaflet type on uptake, which is surprising, given that behaviourally informed letters have improved uptake of NHSHCs. It is possible that people do not pay attention to leaflets that are enclosed with letters, or that the leaflet continues to support informed decision-making but this does not affect uptake. Trial registration Clinicaltrials.gov, NCT03524131. Registered May 14, 2018. Retrospectively registered.

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Pragmatic randomised trial of a smartphone app (NRT2Quit) to improve effectiveness of nicotine replacement therapy in a quit attempt by improving medication adherence - results of a prematurely terminated study

10.21203/rs.2.440/v1 ◽

2019 ◽

Author(s):

Aleksandra Herbec ◽

Jamie Brown ◽

Lion Shahab ◽

Robert West ◽

Tobias Raupach

Keyword(s):

Replacement Therapy ◽

Nicotine Replacement Therapy ◽

Bayes Factor ◽

Controlled Trial ◽

Randomised Trial ◽

Smartphone App ◽

Community Pharmacies ◽

Double Blind ◽

Nicotine Replacement

Abstract Background Nicotine replacement therapy (NRT) bought over the counter (OTC) appears to be largely ineffective for smoking cessation, which may be partially explained by poor adherence. We developed and evaluated the NRT2Quit smartphone app (for iOS) designed to improve quit attempts with OTC NRT by improving adherence to the medications. Methods A pragmatic double-blind randomized controlled trial with remote recruitment through leaflets distributed to over 300 UK-based community pharmacies. The study recruited adult daily smokers (≥10 cig/day) who bought NRT, wanted to quit smoking, downloaded NTR2Quit and completed the registration process within the app. Participants were automatically randomized within the app to the intervention (full) version of NRT2Quit or to its control (minimal) versions. The primary outcome was biochemically-verified 4-week abstinence assessed at 8-week follow-up using Russell Standard criteria and intention-to-treat. Bayes factors were calculated for the cessation outcome. Secondary outcomes were self-reported abstinence, NRT use, app use and satisfaction with the app. Results The study under-recruited with only 41 participants (3.5% of the target sample) randomly assigned to NRT2Quit (n=16) or the control (n=25) app versions between March 2015-September 2016. The follow-up rate was 51.2%. The intervention participants had numerically higher biochemically-verified quit rates (25.0% vs 8.0%, p=0.19, OR=3.83,0.61-24.02). The Bayes factor calculated was 1.92, suggesting anecdotal level of support for the hypothesis that the intervention app version aided cessation, but showed the data were insensitive. The intervention participants had higher median logins (2.5 vs. 0, p=0.01), were more likely to use NRT at follow-up (100.0% vs. 28.6%, p=0.03) and recommend NRT2Quit to others (100.0% vs. 28.6%, p=0.01). Conclusions Despite very low recruitment there was preliminary but inconclusive evidence that NRT2Quit may improve short-term abstinence and adherence among smokers using nicotine replacement therapy. Well-powered studies on NRT2Quit are needed, but different recruitment methods will be required to engage smokers through community pharmacies or other channels.

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