Thank you for inviting us to reply to the letter from Dr Tisi who is concerned that our conclusions are not justified by our results. Taking the points he makes in turn:
There were not 152 eligible patients: 152 patients were referred by their GP for specialist obesity support. These children were screened for eligibility and 31 were not deemed suitable for the trial because of obesity related comorbidities. This left a further 45 who declined to participate in the trial for various reasons. These 76 patients did not provide trial data and will have received treatment in secondary care in the usual way. It is therefore erroneous to suggest that only 39 of 152 people made it through to the end of the trial. As we make clear in our consort diagram, 39 of the 76 who were randomised completed treatment but 52 provided outcome data and were included in an intention to treat analysis.
We have been explicit in our acknowledgement of the modest improvement in body mass index (BMI) standard deviation score (SDS) but as we point out this is still better than described in the recent Cochrane Review. However, the main aim of the trial was to establish the feasibility of running a fully powered trial in primary care and to this end we looked at a range of measures including: whether patients referred for obesity support were clinically suitable for primary care (121, 80% suitable); the willingness of families to be randomised to primary care (45, 30% declined trial participation); and the degree to which families randomised to primary care engaged with the service (measured with the main clinical outcome of BMI SDS change, patient satisfaction, and adherence rates, all of which are detailed in the article and comparable between the trial arms).
We recognise that in a full trial a longer- term outcome measure is essential but in a feasibility study such as this there were insufficient resources available and long-term efficacy was not an objective. However, this does not undermine the rationale for the study which was to assess the feasibility of running a specialist obesity service in primary care in order to proceed to a fully powered trial. Once such trials have been conducted and are open to scrutiny, we should be better placed to assess the value of realigning healthcare resources.
We hope that he will agree that our findings justify further research to develop interventions in the primary care setting that may assist families needing help with managing childhood obesity.