ObjectivesTo evaluate effectiveness of a structured one-to-one behaviour change programme on weight loss in obese and overweight individuals.DesignRandomised controlled trial.Setting23 general practices in Camden, London.Participants381 adults with body mass index ≥25 kg/m2 randomly assigned to intervention (n=191) or control (n=190) group.InterventionsA structured one-to-one programme, delivered over 14 visits during 12 months by trained advisors in three primary care centres compared with usual care in general practice.Outcome measuresChanges in weight, per cent body fat, waist circumference, blood pressure and heart rate between baseline and 12 months.Results217/381 (57.0%) participants were assessed at 12 months: missing values were imputed. The difference in mean weight change between the intervention and control groups was not statistically significant (0.70 kg (0.67 to 2.17, p=0.35)), although a higher proportion of the intervention group (32.7%) than the control group (20.4%) lost 5% or more of their baseline weight (OR: 1.80 (1.02 to 3.18, p=0.04)). The intervention group achieved a lower mean heart rate (mean difference 3.68 beats per minute (0.31 to 7.04, p=0.03)) than the control group. Participants in the intervention group reported higher satisfaction and more positive experiences of their care compared with the control group.ConclusionsAlthough there is no significant difference in mean weight loss between the intervention and control groups, trained non-specialist advisors can deliver a structured programme and achieve clinically beneficial weight loss in some patients in primary care. The intervention group also reported a higher level of satisfaction with the support received. Primary care interventions are unlikely to be sufficient to tackle the obesity epidemic and effective population-wide measures are also necessary.Clinical trial registration numberTrial registrationClincaltrials.gov NCT00891943.
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