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Health4Life eHealth intervention to modify multiple lifestyle risk behaviours among adolescent students in Australia: a cluster-randomised controlled trial.
Champion, KE, Newton, NC, Gardner, LA, Chapman, C, Thornton, L, Slade, T, Sunderland, M, Hides, L, McBride, N, O'Dean, S, et al
The Lancet. Digital health. 2023;(5):e276-e287
Abstract
BACKGROUND Lifestyle risk behaviours are prevalent among adolescents and commonly co-occur, but current intervention approaches tend to focus on single risk behaviours. This study aimed to evaluate the efficacy of the eHealth intervention Health4Life in modifying six key lifestyle risk behaviours (ie, alcohol use, tobacco smoking, recreational screen time, physical inactivity, poor diet, and poor sleep, known as the Big 6) among adolescents. METHODS We conducted a cluster-randomised controlled trial in secondary schools that had a minimum of 30 year 7 students, in three Australian states. A biostatistician randomly allocated schools (1:1) to Health4Life (a six-module, web-based programme and accompanying smartphone app) or an active control group (usual health education) with the Blockrand function in R, stratified by site and school gender composition. All students aged 11-13 years who were fluent in English and attended participating schools were eligible. Teachers, students, and researchers were not masked to allocation. Primary outcomes were alcohol use, tobacco use, recreational screen time, moderate to vigorous physical activity (MVPA), sugar-sweetened beverage intake, and sleep duration at 24 months, measured by self-report surveys, and analysed in all students who were eligible at baseline. Latent growth models estimated between-group change over time. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12619000431123). FINDINGS Between April 1, 2019, and Sept 27, 2019, we recruited 85 schools (9280 students), of which 71 schools with 6640 eligible students (36 schools [3610 students] assigned to the intervention and 35 [3030 students] to the control) completed the baseline survey. 14 schools were excluded from the final analysis or withdrew, mostly due to a lack of time. We found no between-group differences for alcohol use (odds ratio 1·24, 95% CI 0·58-2·64), smoking (1·68, 0·76-3·72), screen time (0·79, 0·59-1·06), MVPA (0·82, 0·62-1·09), sugar-sweetened beverage intake (1·02, 0·82-1·26), or sleep (0·91, 0·72-1·14) at 24 months. No adverse events were reported during this trial. INTERPRETATION Health4Life was not effective in modifying risk behaviours. Our results provide new knowledge about eHealth multiple health behaviour change interventions. However, further research is needed to improve efficacy. FUNDING Paul Ramsay Foundation, the Australian National Health and Medical Research Council, the Australian Government Department of Health and Aged Care, and the US National Institutes of Health.
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A randomised controlled trial of the effect of providing online risk information and lifestyle advice for the most common preventable cancers.
Masson, G, Mills, K, Griffin, SJ, Sharp, SJ, Klein, WMP, Sutton, S, Usher-Smith, JA
Preventive medicine. 2020;:106154
Abstract
Few trial data are available concerning the impact of personalised cancer risk information on behaviour. This study assessed the short-term effects of providing personalised cancer risk information on cancer risk beliefs and self-reported behaviour. We randomised 1018 participants, recruited through the online platform Prolific, to either a control group receiving cancer-specific lifestyle advice or one of three intervention groups receiving their computed 10-year risk of developing one of the five most common preventable cancers either as a bar chart, a pictograph or a qualitative scale alongside the same lifestyle advice. The primary outcome was change from baseline in computed risk relative to an individual with a recommended lifestyle (RRI)1 at three months. Secondary outcomes included: health-related behaviours, risk perception, anxiety, worry, intention to change behaviour, and a newly defined concept, risk conviction. After three months there were no between-group differences in change in RRI (p = 0.71). At immediate follow-up, accuracy of absolute risk perception (p < 0.001), absolute and comparative risk conviction (p < 0.001) and intention to increase fruit and vegetables (p = 0.026) and decrease processed meat (p = 0.033) were higher in all intervention groups relative to the control group. The increases in accuracy and conviction were only seen in individuals with high numeracy and low baseline conviction, respectively. These findings suggest that personalised cancer risk information alongside lifestyle advice can increase short-term risk accuracy and conviction without increasing worry or anxiety but has little impact on health-related behaviour. Trial registration: ISRCTN17450583. Registered 30 January 2018.
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Study protocol of the Health4Life initiative: a cluster randomised controlled trial of an eHealth school-based program targeting multiple lifestyle risk behaviours among young Australians.
Teesson, M, Champion, KE, Newton, NC, Kay-Lambkin, F, Chapman, C, Thornton, L, Slade, T, Sunderland, M, Mills, K, Gardner, LA, et al
BMJ open. 2020;(7):e035662
Abstract
INTRODUCTION Lifestyle risk behaviours, including alcohol use, smoking, poor diet, physical inactivity, poor sleep (duration and/or quality) and sedentary recreational screen time ('the Big 6'), are strong determinants of chronic disease. These behaviours often emerge during adolescence and co-occur. School-based interventions have the potential to address risk factors prior to the onset of disease, yet few eHealth school-based interventions target multiple behaviours concurrently. This paper describes the protocol of the Health4Life Initiative, an eHealth school-based intervention that concurrently addresses the Big 6 risk behaviours among secondary school students. METHODS AND ANALYSIS A multisite cluster randomised controlled trial will be conducted among year 7 students (11-13 years old) from 72 Australian schools. Stratified block randomisation will be used to assign schools to either the Health4Life intervention or an active control (health education as usual). Health4Life consists of (1) six web-based cartoon modules and accompanying activities delivered during health education (once per week for 6 weeks), and a smartphone application (universal prevention), and (2) additional app content, for students engaging in two or more risk behaviours when they are in years 8 and 9 (selective prevention). Students will complete online self-report questionnaires at baseline, post intervention, and 12, 24 and 36 months after baseline. Primary outcomes are consumption of sugar-sweetened beverages, moderate-to-vigorous physical activity, sleep duration, sedentary recreational screen time and uptake of alcohol and tobacco use. ETHICS AND DISSEMINATION This study has been approved by the University of Sydney (2018/882), NSW Department of Education (SERAP no. 2019006), University of Queensland (2019000037), Curtin University (HRE2019-0083) and relevant Catholic school committees. Results will be presented to schools and findings disseminated via peer-reviewed journals and scientific conferences. This will be the first evaluation of an eHealth intervention, spanning both universal and selective prevention, to simultaneously target six key lifestyle risk factors among adolescents. TRIAL REGISTRATION NUMBER Australian New Zealand Clinical Trials Registry (ACTRN12619000431123), 18 March 2019.
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A randomised controlled trial of the effect of providing online risk information and lifestyle advice for the most common preventable cancers: study protocol.
Usher-Smith, JA, Masson, G, Mills, K, Sharp, SJ, Sutton, S, Klein, WMP, Griffin, SJ
BMC public health. 2018;(1):796
Abstract
BACKGROUND Cancer is a leading cause of mortality and morbidity worldwide. Prevention is recognised by many, including the World Health Organization, to offer the most cost-effective long-term strategy for the control of cancer. One approach that focuses on individuals is the provision of personalised risk information. However, whether such information motivates behaviour change and whether the effect is different with varying formats of risk presentation is unclear. We aim to assess the short-term effect of providing information about personalised risk of cancer in three different formats alongside lifestyle advice on health-related behaviours, risk perception and risk conviction. METHODS In a parallel group, randomised controlled trial 1000 participants will be recruited through the online platform Prolific. Participants will be allocated to either a control group receiving cancer-specific lifestyle advice alone or one of three intervention groups receiving the same lifestyle advice alongside their estimated 10-year risk of developing one of the five most common preventable cancers, calculated from self-reported modifiable behavioural risk factors, in one of three different formats (bar chart, pictograph or qualitative scale). The primary outcome is change from baseline in computed risk relative to an individual with a recommended lifestyle at three months. Secondary outcomes include: perceived risk of cancer; anxiety; cancer-related worry; intention to change behaviour; and awareness of cancer risk factors. DISCUSSION This study will provide evidence on the short-term effect of providing online information about personalised risk of cancer alongside lifestyle advice on risk perception and health-related behaviours and inform the development of interventions. TRIAL REGISTRATION ISRCTN17450583. Registered 30 January 2018.
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Impact of baseline vitamin B12 status on the effect of vitamin B12 supplementation on neurologic function in older people: secondary analysis of data from the OPEN randomised controlled trial.
Miles, LM, Allen, E, Clarke, R, Mills, K, Uauy, R, Dangour, AD
European journal of clinical nutrition. 2017;(10):1166-1172
Abstract
BACKGROUND/OBJECTIVES The available evidence from randomised controlled trials suggests that vitamin B12 supplementation does not improve neurologic function in older people with marginal but not deficient Vitamin B12 status. This secondary analysis used data from the Older People and Enhanced Neurological function (OPEN) randomised controlled trial to assess whether baseline vitamin B12 status or change in vitamin B12 status over 12 months altered the effectiveness of dietary vitamin B12 supplementation on neurologic function in asymptomatic older people with depleted vitamin B12 status at study entry. SUBJECTS/METHODS Vitamin B12 status was measured as serum concentrations of vitamin B12, holotranscobalamin, homocysteine and via a composite indicator (cB12). Neurological function outcomes included eleven electrophysiological measures of sensory and motor components of peripheral and central nerve function. Linear regression analyses were restricted to participants randomised into the intervention arm of the OPEN trial (n=91). RESULTS Analyses revealed an inconsistent pattern of moderate associations between some measures of baseline vitamin B12 status and some neurological responses to supplementation. The directions of effect varied and heterogeneity in effect across outcomes could not be explained according to type of neurological outcome. There was no evidence of differences in the neurological response to vitamin B12 supplementation according to change from baseline over 12 months in any indicator of B12 status. CONCLUSIONS This secondary analysis of high-quality data from the OPEN trial provides no evidence that baseline (or change from baseline) vitamin B12 status modifies the effect of vitamin B12 supplementation on peripheral or central nerve conduction among older people with marginal vitamin B12 status. There is currently insufficient evidence of efficacy for neurological function to support population-wide recommendations for vitamin B12 supplementation in healthy asymptomatic older people with marginal vitamin B12 status.
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Vitamin B-12 status and neurologic function in older people: a cross-sectional analysis of baseline trial data from the Older People and Enhanced Neurological Function (OPEN) study.
Miles, LM, Allen, E, Mills, K, Clarke, R, Uauy, R, Dangour, AD
The American journal of clinical nutrition. 2016;(3):790-6
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Abstract
BACKGROUND Aging is associated with a progressive decline in vitamin B-12 status. Overt vitamin B-12 deficiency causes neurologic disturbances in peripheral and central motor and sensory systems, but the public health impact for neurologic disease of moderately low vitamin B-12 status in older people is unclear. Evidence from observational studies is limited by heterogeneity in the definition of vitamin B-12 status and imprecise measures of nerve function. OBJECTIVE We aimed to determine whether vitamin B-12 status is associated with electrophysiologic indexes of peripheral or central neurologic function in asymptomatic older people with moderately low vitamin B-12 status. DESIGN We used a cross-sectional analysis of baseline data from the Older People and Enhanced Neurological Function study conducted in Southeast England. This trial investigated the effectiveness of vitamin B-12 supplementation on electrophysiologic indexes of neurologic function in asymptomatic older people (mean age: 80 y) with moderately low vitamin B-12 status (serum vitamin B-12 concentrations ≥107 and <210 pmol/L without anemia, n = 201). Vitamin B-12 status was assessed with the use of total vitamin B-12, holotranscobalamin, and a composite indicator of vitamin B-12 status (cB-12). Electrophysiologic measures of sensory and motor components of peripheral and central nerve function were assessed in all participants by a single observer. RESULTS In multivariate models, there was no evidence of an association of vitamin B-12, holotranscobalamin, or cB-12 with any nerve conduction outcome. There was also no evidence of an association of vitamin B-12 status with clinical markers of neurologic function. CONCLUSION This secondary analysis of high-quality trial data did not show any association of any measure of vitamin B-12 status with either peripheral or central neurologic function or any clinical markers of neurologic function in older people with moderately low vitamin B-12 status. The results of this study are unlikely to be generalizable to a less healthy older population with more severe vitamin B-12 deficiency. This trial was registered at www.controlled-trials.com as ISRCTN54195799.
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Effects of vitamin B-12 supplementation on neurologic and cognitive function in older people: a randomized controlled trial.
Dangour, AD, Allen, E, Clarke, R, Elbourne, D, Fletcher, AE, Letley, L, Richards, M, Whyte, K, Uauy, R, Mills, K
The American journal of clinical nutrition. 2015;(3):639-47
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BACKGROUND Moderate vitamin B-12 deficiency is relatively common in older people. However, there is little robust evidence on the effect of vitamin B-12 supplementation on neurologic and cognitive outcomes in later life. OBJECTIVE We investigated whether vitamin B-12 supplementation benefits neurologic and cognitive function in moderately vitamin B-12-deficient older people. DESIGN We conducted a double-blind, randomized, placebo-controlled trial in 7 general practices in South East England, United Kingdom. Study participants were aged ≥75 y and had moderate vitamin B-12 deficiency (serum vitamin B-12 concentrations: 107-210 pmol/L) in the absence of anemia and received 1 mg crystalline vitamin B-12 or a matching placebo as a daily oral tablet for 12 mo. Peripheral motor and sensory nerve conduction, central motor conduction, a clinical neurologic examination, and cognitive function were assessed before and after treatment. RESULTS A total of 201 participants were enrolled in the trial, and 191 subjects provided outcome data. Compared with baseline, allocation to vitamin B-12 was associated with a 177% increase in serum concentration of vitamin B-12 (641 compared with 231 pmol/L), a 331% increase in serum holotranscobalamin (240 compared with 56 pmol/L), and 17% lower serum homocysteine (14.2 compared with 17.1 μmol/L). In intention-to-treat analysis of covariance models, with adjustment for baseline neurologic function, there was no evidence of an effect of supplementation on the primary outcome of the posterior tibial compound muscle action potential amplitude at 12 mo (mean difference: -0.2 mV; 95% CI: -0.8, 0.3 mV). There was also no evidence of an effect on any secondary peripheral nerve or central motor function outcome, or on cognitive function or clinical examination. CONCLUSION Results of the trial do not support the hypothesis that the correction of moderate vitamin B-12 deficiency, in the absence of anemia and of neurologic and cognitive signs or symptoms, has beneficial effects on neurologic or cognitive function in later life. This trial was registered at www.isrctn.com as ISRCTN54195799.
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A randomised controlled trial investigating the effect of vitamin B12 supplementation on neurological function in healthy older people: the Older People and Enhanced Neurological function (OPEN) study protocol [ISRCTN54195799].
Dangour, AD, Allen, E, Clarke, R, Elbourne, D, Fasey, N, Fletcher, AE, Letley, L, Richards, M, Whyte, K, Mills, K, et al
Nutrition journal. 2011;:22
Abstract
BACKGROUND Vitamin B12 deficiency is common in older people and the prevalence increases with age. Vitamin B12 deficiency may present as macrocytic anaemia, subacute combined degeneration of the spinal cord, or as neuropathy, but is often asymptomatic in older people. The diagnosis and indications for treatment are clear for individuals with low plasma levels of vitamin B12 in the setting of megaloblastic anaemia and neuropathy, but the relevance of treatment of vitamin B12 deficiency in the absence of such clinical signs is uncertain. METHODS The aim of the present study is to assess whether dietary supplementation with crystalline vitamin B12 will improve electrophysiological indices of neurological function in older people who have biochemical evidence of vitamin B12 insufficiency in the absence of anaemia. To test this hypothesis we designed a randomized double-blind placebo-controlled trial involving 200 older people aged 75 years or greater who were randomly allocated to receive either a daily oral tablet containing 1 mg vitamin B12 or a matching placebo tablet. The primary outcome assessed at 12 months is change in electrophysiological indices of peripheral and central neurosensory responses required for mobility and sensory function. We here report the detailed study protocol. CONCLUSIONS In view of the high prevalence of vitamin B12 deficiency in later life, the present trial could have considerable significance for public health.