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Effect of Urate-Elevating Inosine on Early Parkinson Disease Progression: The SURE-PD3 Randomized Clinical Trial.
, , Schwarzschild, MA, Ascherio, A, Casaceli, C, Curhan, GC, Fitzgerald, R, Kamp, C, Lungu, C, Macklin, EA, Marek, K, et al
JAMA. 2021;(10):926-939
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Abstract
IMPORTANCE Urate elevation, despite associations with crystallopathic, cardiovascular, and metabolic disorders, has been pursued as a potential disease-modifying strategy for Parkinson disease (PD) based on convergent biological, epidemiological, and clinical data. OBJECTIVE To determine whether sustained urate-elevating treatment with the urate precursor inosine slows early PD progression. DESIGN, PARTICIPANTS, AND SETTING Randomized, double-blind, placebo-controlled, phase 3 trial of oral inosine treatment in early PD. A total of 587 individuals consented, and 298 with PD not yet requiring dopaminergic medication, striatal dopamine transporter deficiency, and serum urate below the population median concentration (<5.8 mg/dL) were randomized between August 2016 and December 2017 at 58 US sites, and were followed up through June 2019. INTERVENTIONS Inosine, dosed by blinded titration to increase serum urate concentrations to 7.1-8.0 mg/dL (n = 149) or matching placebo (n = 149) for up to 2 years. MAIN OUTCOMES AND MEASURES The primary outcome was rate of change in the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS; parts I-III) total score (range, 0-236; higher scores indicate greater disability; minimum clinically important difference of 6.3 points) prior to dopaminergic drug therapy initiation. Secondary outcomes included serum urate to measure target engagement, adverse events to measure safety, and 29 efficacy measures of disability, quality of life, cognition, mood, autonomic function, and striatal dopamine transporter binding as a biomarker of neuronal integrity. RESULTS Based on a prespecified interim futility analysis, the study closed early, with 273 (92%) of the randomized participants (49% women; mean age, 63 years) completing the study. Clinical progression rates were not significantly different between participants randomized to inosine (MDS-UPDRS score, 11.1 [95% CI, 9.7-12.6] points per year) and placebo (MDS-UPDRS score, 9.9 [95% CI, 8.4-11.3] points per year; difference, 1.26 [95% CI, -0.59 to 3.11] points per year; P = .18). Sustained elevation of serum urate by 2.03 mg/dL (from a baseline level of 4.6 mg/dL; 44% increase) occurred in the inosine group vs a 0.01-mg/dL change in serum urate in the placebo group (difference, 2.02 mg/dL [95% CI, 1.85-2.19 mg/dL]; P<.001). There were no significant differences for secondary efficacy outcomes including dopamine transporter binding loss. Participants randomized to inosine, compared with placebo, experienced fewer serious adverse events (7.4 vs 13.1 per 100 patient-years) but more kidney stones (7.0 vs 1.4 stones per 100 patient-years). CONCLUSIONS AND RELEVANCE Among patients recently diagnosed as having PD, treatment with inosine, compared with placebo, did not result in a significant difference in the rate of clinical disease progression. The findings do not support the use of inosine as a treatment for early PD. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02642393.
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Effectiveness of a childhood obesity prevention programme delivered through schools, targeting 6 and 7 year olds: cluster randomised controlled trial (WAVES study).
Adab, P, Pallan, MJ, Lancashire, ER, Hemming, K, Frew, E, Barrett, T, Bhopal, R, Cade, JE, Canaway, A, Clarke, JL, et al
BMJ (Clinical research ed.). 2018;360:k211
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Plain language summary
Excess weight in childhood is a global problem affecting around 41 million children under the age of 5 years. In addition to physical and psychosocial health consequences in these early years, childhood excess weight is an important predictor of obesity in adulthood. The aim of the study is to assess the effectiveness of a school and family based healthy lifestyle programme (WAVES intervention) compared with usual practice, in preventing childhood obesity. The primary outcome for clinical effectiveness was the difference in BMI z scores between arms at 15 and 30 months. The study was a school based, cluster randomised, controlled trial where 200 schools were randomly selected from all state run primary schools within 35miles of the study centre (n=980). 144 eligible schools were approached to achieve the target recruitment of 54 schools. The intervention components were delivered over a period of 12 months and targeted the home and school environment. The results show that there was no overall evidence of improvement in the primary outcomes of reduction in body mass index (BMI) z scores at 15 and 30 months after a childhood obesity prevention programme was delivered through schools and targeting 6 and 7-year olds. The intervention did not have any effects on secondary anthropometric, behavioural, or clinical outcomes. A clinically significant difference in BMI z score in favour of the intervention was seen in the first cohort of schools recruited. However, post hoc analysis suggested that this outcome may have been a cohort effect as no effect was seen in group 2 schools at any time point. Authors conclude that the study intervention did not result in a statistically significant difference in BMI z score overall, and there was no evidence of effect on measured diet or physical activity levels in children. However, the lower cost components of the intervention could be considered by schools to fulfil their mandated responsibilities for education on health and wellbeing.
Abstract
OBJECTIVE To assess the effectiveness of a school and family based healthy lifestyle programme (WAVES intervention) compared with usual practice, in preventing childhood obesity. DESIGN Cluster randomised controlled trial. SETTING UK primary schools from the West Midlands. PARTICIPANTS 200 schools were randomly selected from all state run primary schools within 35 miles of the study centre (n=980), oversampling those with high minority ethnic populations. These schools were randomly ordered and sequentially invited to participate. 144 eligible schools were approached to achieve the target recruitment of 54 schools. After baseline measurements 1467 year 1 pupils aged 5 and 6 years (control: 28 schools, 778 pupils) were randomised, using a blocked balancing algorithm. 53 schools remained in the trial and data on 1287 (87.7%) and 1169 (79.7%) pupils were available at first follow-up (15 month) and second follow-up (30 month), respectively. INTERVENTIONS The 12 month intervention encouraged healthy eating and physical activity, including a daily additional 30 minute school time physical activity opportunity, a six week interactive skill based programme in conjunction with Aston Villa football club, signposting of local family physical activity opportunities through mail-outs every six months, and termly school led family workshops on healthy cooking skills. MAIN OUTCOME MEASURES The protocol defined primary outcomes, assessed blind to allocation, were between arm difference in body mass index (BMI) z score at 15 and 30 months. Secondary outcomes were further anthropometric, dietary, physical activity, and psychological measurements, and difference in BMI z score at 39 months in a subset. RESULTS Data for primary outcome analyses were: baseline, 54 schools: 1392 pupils (732 controls); first follow-up (15 months post-baseline), 53 schools: 1249 pupils (675 controls); second follow-up (30 months post-baseline), 53 schools: 1145 pupils (621 controls). The mean BMI z score was non-significantly lower in the intervention arm compared with the control arm at 15 months (mean difference -0.075 (95% confidence interval -0.183 to 0.033, P=0.18) in the baseline adjusted models. At 30 months the mean difference was -0.027 (-0.137 to 0.083, P=0.63). There was no statistically significant difference between groups for other anthropometric, dietary, physical activity, or psychological measurements (including assessment of harm). CONCLUSIONS The primary analyses suggest that this experiential focused intervention had no statistically significant effect on BMI z score or on preventing childhood obesity. Schools are unlikely to impact on the childhood obesity epidemic by incorporating such interventions without wider support across multiple sectors and environments. TRIAL REGISTRATION Current Controlled Trials ISRCTN97000586.
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The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study: a cluster randomised controlled trial testing the clinical effectiveness and cost-effectiveness of a multifaceted obesity prevention intervention programme targeted at children aged 6-7 years.
Adab, P, Barrett, T, Bhopal, R, Cade, JE, Canaway, A, Cheng, KK, Clarke, J, Daley, A, Deeks, J, Duda, J, et al
Health technology assessment (Winchester, England). 2018;(8):1-608
Abstract
BACKGROUND Systematic reviews suggest that school-based interventions can be effective in preventing childhood obesity, but better-designed trials are needed that consider costs, process, equity, potential harms and longer-term outcomes. OBJECTIVE To assess the clinical effectiveness and cost-effectiveness of the WAVES (West Midlands ActiVe lifestyle and healthy Eating in School children) study intervention, compared with usual practice, in preventing obesity among primary school children. DESIGN A cluster randomised controlled trial, split across two groups, which were randomised using a blocked balancing algorithm. Schools/participants could not be blinded to trial arm. Measurement staff were blind to allocation arm as far as possible. SETTING Primary schools, West Midlands, UK. PARTICIPANTS Schools within a 35-mile radius of the study centre and all year 1 pupils (aged 5-6 years) were eligible. Schools with a higher proportion of pupils from minority ethnic populations were oversampled to enable subgroup analyses. INTERVENTIONS The 12-month intervention encouraged healthy eating/physical activity (PA) by (1) helping teachers to provide 30 minutes of additional daily PA, (2) promoting 'Villa Vitality' (interactive healthy lifestyles learning, in an inspirational setting), (3) running school-based healthy cooking skills/education workshops for parents and children and (4) highlighting information to families with regard to local PA opportunities. MAIN OUTCOME MEASURES The primary outcomes were the difference in body mass index z-scores (BMI-zs) between arms (adjusted for baseline body mass index) at 3 and 18 months post intervention (clinical outcome), and cost per quality-adjusted life-year (QALY) (cost-effectiveness outcome). The secondary outcomes were further anthropometric, dietary, PA and psychological measurements, and the difference in BMI-z between arms at 27 months post intervention in a subset of schools. RESULTS Two groups of schools were randomised: 27 in 2011 (n = 650 pupils) [group 1 (G1)] and another 27 in 2012 (n = 817 pupils) [group 2 (G2)]. Primary outcome data were available at first follow-up (n = 1249 pupils) and second follow-up (n = 1145 pupils) from 53 schools. The mean difference (MD) in BMI-z between the control and intervention arms was -0.075 [95% confidence interval (CI) -0.183 to 0.033] and -0.027 (95% CI -0.137 to 0.083) at 3 and 18 months post intervention, respectively. The main analyses showed no evidence of between-arm differences for any secondary outcomes. Third follow-up included data on 467 pupils from 27 G1 schools, and showed a statistically significant difference in BMI-z (MD -0.20, 95% CI -0.40 to -0.01). The mean cost of the intervention was £266.35 per consented child (£155.53 per child receiving the intervention). The incremental cost-effectiveness ratio associated with the base case was £46,083 per QALY (best case £26,804 per QALY), suggesting that the intervention was not cost-effective. LIMITATIONS The presence of baseline primary outcome imbalance between the arms, and interschool variation in fidelity of intervention delivery. CONCLUSIONS The primary analyses show no evidence of clinical effectiveness or cost-effectiveness of the WAVES study intervention. A post hoc analysis, driven by findings at third follow-up, suggests a possible intervention effect, which could have been attenuated by baseline imbalances. There was no evidence of an intervention effect on measures of diet or PA and no evidence of harm. FUTURE WORK A realist evidence synthesis could provide insights into contextual factors and strategies for future interventions. School-based interventions need to be integrated within a wider societal framework and supported by upstream interventions. TRIAL REGISTRATION Current Controlled Trials ISRCTN97000586. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 8. See the NIHR Journals Library website for further project information.
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Exercise to preserve β-cell function in recent-onset Type 1 diabetes mellitus (EXTOD) - a randomized controlled pilot trial.
Narendran, P, Jackson, N, Daley, A, Thompson, D, Stokes, K, Greenfield, S, Charlton, M, Curran, M, Solomon, TPJ, Nouwen, A, et al
Diabetic medicine : a journal of the British Diabetic Association. 2017;(11):1521-1531
Abstract
AIM: Residual β-cell function is present at the time of diagnosis with Type 1 diabetes. Preserving this β-cell function reduces complications. We hypothesized that exercise preserves β-cell function in Type 1 diabetes and undertook a pilot trial to address the key uncertainties in designing a definitive trial to test this hypothesis. METHODS A randomized controlled pilot trial in adults aged 16-60 years diagnosed with Type 1 diabetes within the previous 3 months was undertaken. Participants were assigned to control (usual care) or intervention (exercise consultation every month), in a 1 : 1 ratio for 12 months. The primary outcomes were recruitment rate, drop out, exercise adherence [weeks with ≥ 150 min of self-reported moderate to vigorous physical activity (MVPA)], and exercise uptake in the control group. The secondary outcomes were differences in insulin sensitivity and rate of loss of β-cell function between intervention and control at 6 and 12 months. RESULTS Of 507 individuals who were approached, 58 (28 control, 30 intervention) entered the study and 41 completed it. Participants were largely white European males, BMI 24.8 ± 3.8 kg/m2 , HbA1c 75 ± 25 mmol/mol (9 ± 2%). Mean level of objectively measured MVPA increased in the intervention group (mean 243 to 273 min/week) and 61% of intervention participants reached the target of ≥ 150 min/week of self-reported MVPA on at least 42 weeks of the year. Physical activity levels fell slightly in the control group (mean 277 to 235 min of MVPA/week). There was exploratory evidence that intervention group became more insulin sensitive and required less insulin. However, the rate of loss of β-cell function appeared similar between the groups, although the change in insulin sensitivity may have affected this. CONCLUSION We show that it is possible to recruit and randomize people with newly diagnosed Type 1 diabetes to a trial of an exercise intervention, and increase and maintain their exercise levels for 12 months. Future trials need to incorporate measures of greater adherence to exercise training targets, and include more appropriate measures of β-cell function. (Clinical Trials Registry No; ISRCTN91388505).
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A cluster-randomised controlled trial to assess the effectiveness and cost-effectiveness of a childhood obesity prevention programme delivered through schools, targeting 6-7 year old children: the WAVES study protocol.
Adab, P, Pallan, MJ, Lancashire, ER, Hemming, K, Frew, E, Griffin, T, Barrett, T, Bhopal, R, Cade, JE, Daley, A, et al
BMC public health. 2015;:488
Abstract
BACKGROUND There is some evidence that school-based interventions are effective in preventing childhood obesity. However, longer term outcomes, equity of effects and cost-effectiveness of interventions have not been assessed. The aim of this trial is to assess the clinical and cost-effectiveness of a multi-component intervention programme targeting the school and family environment through primary schools, in preventing obesity in 6-7 year old children, compared to usual practice. METHODS This cluster randomised controlled trial is set in 54 primary schools within the West Midlands, UK, including a multi-ethnic, socioeconomically diverse population of children aged 6-7 years. The 12-month intervention consists of healthy diet and physical activity promotion. These include: activities to increase time spent doing physical activity within the school day, participation in the 'Villa Vitality' programme (a programme that is delivered by an iconic sporting institution (Aston Villa Football Club), which provides interactive learning opportunities for physical activity and healthy eating), healthy cooking skills workshops in school time for parents and children, and provision of information to families signposting local leisure opportunities. The primary (clinical) outcome is the difference in body mass index (BMI) z-scores between arms at 3 and 18 months post-intervention completion. Cost per Quality Adjusted Life Year (QALY) will also be assessed. The sample size estimate (1000 children split across 50 schools at follow-up) is based on 90% power to detect differences in BMI z-score of 0.25 (estimated ICC ≤ 0.04), assuming a correlation between baseline and follow-up BMI z-score of 0.9. Treatment effects will be examined using mixed model ANCOVA. Primary analysis will adjust for baseline BMI z-score, and secondary analysis will adjust for pre-specified baseline school and child level covariates. DISCUSSION The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study is the first trial that will examine the cost-effectiveness and long term outcomes of a childhood obesity prevention programme in a multi-ethnic population, with a sufficient sample size to detect clinically important differences in adiposity. The intervention was developed using the Medical Research Council framework for complex interventions, and outcomes are measured objectively, together with a comprehensive process evaluation. TRIAL REGISTRATION Current Controlled Trials ISRCTN97000586 (registered May 2010).
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Preventing childhood obesity, phase II feasibility study focusing on South Asians: BEACHeS.
Adab, P, Pallan, MJ, Cade, J, Ekelund, U, Barrett, T, Daley, A, Deeks, J, Duda, J, Gill, P, Parry, J, et al
BMJ open. 2014;(4):e004579
Abstract
OBJECTIVE To assess feasibility and acceptability of a multifaceted, culturally appropriate intervention for preventing obesity in South Asian children, and to obtain data to inform sample size for a definitive trial. DESIGN Phase II feasibility study of a complex intervention. SETTING 8 primary schools in inner city Birmingham, UK, within populations that are predominantly South Asian. PARTICIPANTS 1090 children aged 6-8 years took part in the intervention. 571 (85.9% from South Asian background) underwent baseline measures. 85.5% (n=488) were followed up 2 years later. INTERVENTIONS The 1-year intervention consisted of school-based and family-based activities, targeting dietary and physical activity behaviours. The intervention was modified and refined throughout the period of delivery. MAIN OUTCOME MEASURES Acceptability and feasibility of the intervention and of measurements required to assess outcomes in a definitive trial. The difference in body mass index (BMI) z-score between arms was used to inform sample size calculations for a definitive trial. RESULTS Some intervention components (increasing school physical activity opportunities, family cooking skills workshops, signposting of local leisure facilities and attending day event at a football club) were feasible and acceptable. Other components were acceptable, but not feasible. Promoting walking groups was neither acceptable nor feasible. At follow-up, children in the intervention compared with the control group were less likely to be obese (OR 0.41; 0.19 to 0.89), and had lower adjusted BMI z-score (-0.15 kg/m(2); 95% CI -0.27 to -0.03). CONCLUSIONS The feasibility study informed components for an intervention programme. The favourable direction of outcome for weight status in the intervention group supports the need for a definitive trial. A cluster randomised controlled trial is now underway to assess the clinical and cost-effectiveness of the intervention. TRIAL REGISTRATION NUMBER ISRCTN51016370.
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Eating attentively: a systematic review and meta-analysis of the effect of food intake memory and awareness on eating.
Robinson, E, Aveyard, P, Daley, A, Jolly, K, Lewis, A, Lycett, D, Higgs, S
The American journal of clinical nutrition. 2013;(4):728-42
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BACKGROUND Cognitive processes such as attention and memory may influence food intake, but the degree to which they do is unclear. OBJECTIVE The objective was to examine whether such cognitive processes influence the amount of food eaten either immediately or in subsequent meals. DESIGN We systematically reviewed studies that examined experimentally the effect that manipulating memory, distraction, awareness, or attention has on food intake. We combined studies by using inverse variance meta-analysis, calculating the standardized mean difference (SMD) in food intake between experimental and control groups and assessing heterogeneity with the I(2) statistic. RESULTS Twenty-four studies were reviewed. Evidence indicated that eating when distracted produced a moderate increase in immediate intake (SMD: 0.39; 95% CI: 0.25, 0.53) but increased later intake to a greater extent (SMD: 0.76; 95% CI: 0.45, 1.07). The effect of distraction on immediate intake appeared to be independent of dietary restraint. Enhancing memory of food consumed reduced later intake (SMD: 0.40; 95% CI: 0.12, 0.68), but this effect may depend on the degree of the participants' tendencies toward disinhibited eating. Removing visual information about the amount of food eaten during a meal increased immediate intake (SMD: 0.48; 95% CI: 0.27, 0.68). Enhancing awareness of food being eaten may not affect immediate intake (SMD: 0.09; 95% CI: -0.42, 0.35). CONCLUSIONS Evidence indicates that attentive eating is likely to influence food intake, and incorporation of attentive-eating principles into interventions provides a novel approach to aid weight loss and maintenance without the need for conscious calorie counting.
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Comparison of range of commercial or primary care led weight reduction programmes with minimal intervention control for weight loss in obesity: lighten Up randomised controlled trial.
Jolly, K, Lewis, A, Beach, J, Denley, J, Adab, P, Deeks, JJ, Daley, A, Aveyard, P
BMJ (Clinical research ed.). 2011;:d6500
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OBJECTIVE To assess the effectiveness of a range of weight management programmes in terms of weight loss. DESIGN Eight arm randomised controlled trial. SETTING Primary care trust in Birmingham, England. PARTICIPANTS 740 obese or overweight men and women with a comorbid disorder identified from general practice records. INTERVENTIONS Weight loss programmes of 12 weeks' duration: Weight Watchers; Slimming World; Rosemary Conley; group based, dietetics led programme; general practice one to one counselling; pharmacy led one to one counselling; choice of any of the six programmes. The comparator group was provided with 12 vouchers enabling free entrance to a local leisure (fitness) centre. MAIN OUTCOME MEASURES The primary outcome was weight loss at programme end (12 weeks). Secondary outcomes were weight loss at one year, self reported physical activity, and percentage weight loss at programme end and one year. RESULTS Follow-up data were available for 658 (88.9%) participants at programme end and 522 (70.5%) at one year. All programmes achieved significant weight loss from baseline to programme end (range 1.37 kg (general practice) to 4.43 kg (Weight Watchers)), and all except general practice and pharmacy provision resulted in significant weight loss at one year. At one year, only the Weight Watchers group had significantly greater weight loss than did the comparator group (2.5 (95% confidence interval 0.8 to 4.2) kg greater loss,). The commercial programmes achieved significantly greater weight loss than did the primary care programmes at programme end (mean difference 2.3 (1.3 to 3.4) kg). The primary care programmes were the most costly to provide. Participants allocated to the choice arm did not have better outcomes than those randomly allocated to a programme. CONCLUSIONS Commercially provided weight management services are more effective and cheaper than primary care based services led by specially trained staff, which are ineffective. Trial registration Current Controlled Trials ISRCTN25072883.
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Pragmatic lifestyle intervention in patients recovering from colon cancer: a randomized controlled pilot study.
Bourke, L, Thompson, G, Gibson, DJ, Daley, A, Crank, H, Adam, I, Shorthouse, A, Saxton, J
Archives of physical medicine and rehabilitation. 2011;(5):749-55
Abstract
OBJECTIVE To investigate the feasibility of a pragmatic lifestyle intervention in patients who had recently completed surgery and chemotherapy for colon cancer and to obtain preliminary data of its impact on important health outcomes. DESIGN A prospective, randomized, controlled pilot trial. SETTING University rehabilitation facility. PARTICIPANTS Eighteen (N=18) colon cancer survivors (mean age=69y; range, 52-80y), Dukes stage A to C. INTERVENTIONS Participants were randomized 6 to 24 months postoperatively to either a 12-week program of combined exercise and dietary advice or standard treatment. MAIN OUTCOME MEASURES Exercise and dietary behavior, fatigue, health-related quality of life (QOL), aerobic exercise tolerance, functional capacity, muscle strength, and anthropometery were assessed at baseline and immediately after the intervention. RESULTS Adherences to supervised and independent exercise during the intervention were 90% and 94%, respectively, and there was low attrition (6%). The lifestyle intervention elicited improvements in exercise behavior (P=.068), fatigue (P=.005), aerobic exercise tolerance (P=.010), chair sit-to-stand performance (P=.003), and waist-to-hip ratio (P=.002). A positive change in dietary fiber intake (P=.044) was also observed in the intervention group. No change in QOL was observed (P=.795). CONCLUSIONS These preliminary results suggest that a pragmatic lifestyle intervention implemented 6 to 24 months after primary treatment for colon cancer was feasible. We observed a significant impact on dietary behavior, fatigue, aerobic exercise tolerance, functional capacity, and waist-to-hip ratio. These findings need to be confirmed with a larger-scale definitive randomized controlled trial.
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Lifestyle intervention in men with advanced prostate cancer receiving androgen suppression therapy: a feasibility study.
Bourke, L, Doll, H, Crank, H, Daley, A, Rosario, D, Saxton, JM
Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology. 2011;(4):647-57
Abstract
BACKGROUND Healthy lifestyle behaviors could have a role in ameliorating some of the adverse effects of androgen suppression therapy (AST) in men with prostate cancer. The primary aim of this study was to assess the feasibility of a tapered supervised exercise program in combination with dietary advice in men with advanced prostate cancer receiving AST. METHODS Advanced prostate cancer patients receiving AST for a minimum of 6 months were randomized to a 12-week lifestyle program comprising aerobic and resistance exercise, plus dietary advice (n = 25), or standard care (n = 25). Exercise behavior, dietary macronutrient intake, quality of life, fatigue, functional fitness, and biomarkers associated with disease progression were assessed at baseline, after the intervention, and at 6 months. RESULTS The lifestyle group showed improvements in exercise behavior (P < 0.001), dietary fat intake (P = 0.001), total energy intake (P = 0.005), fatigue (P = 0.002), aerobic exercise tolerance (P < 0.001), and muscle strength (P = 0.033) compared with standard care controls. Although a high rate of attrition (44%) was observed at 6 months, the improvements in key health outcomes were sustained. No effects on clinical prostate cancer disease markers were observed. CONCLUSIONS This preliminary evidence suggests that pragmatic lifestyle interventions have potential to evoke improvements in exercise and dietary behavior, in addition to other important health outcomes in men with advanced prostate cancer receiving AST. IMPACT This study shows for the first time that pragmatic lifestyle interventions are feasible and could have a positive impact on health behaviors and other key outcomes in men with advanced prostate cancer receiving AST.