A total of 793 individuals were referred to the study and assessed for eligibility between June 2015 and November 2016. Of these, 366 were randomised to the intervention and control groups (n=183 each; fig 1). The final nine month follow-up assessments were completed in August 2017, with loss to follow-up (that is, no follow-up data on any outcome) low in both groups (overall 7/366=2%). A total of 12 participants (six per group) were excluded from the primary outcome analysis because of no follow-up HbA1c results after randomisation. Baseline characteristics of participants are presented in table 1, and no adverse events were recorded from the study or protocol deviations.
Only children aged <15 yr were included. Type 1 diabetes was diagnosed based on clinical features. All patients had elevated blood glucose at presentation: either a random measurement of ≥11.1 mmol/l and presence of classical symptoms, or fasting blood glucose ≥7.1 mmol/l. In addition, all patients met at least one of the following criteria: a) diabetic ketoacidosis; b) presence of at least two type 1 diabetes antibodies (to glutamic acid decarboxylase, islet antigen 2, islet cell, or insulin autoantibodies); or c) ongoing requirement for insulin therapy. Clinical and demographic data were prospectively recorded on all patients at each outpatient visit.
Contributors: RW obtained funding for this trial. All coauthors had input into the study protocol. RD, RW, RMu, and MS contributed to the development of the intervention content. RD managed the day-to-day running of the trial and delivery of the intervention. RD and RW collected the data. YJ and RD did the data analyses. All coauthors were involved in the interpretation of the results. RD wrote the article with input from all coauthors. All authors, external and internal, had full access to all of the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis. All authors approved the final version of this manuscript. RD is guarantor. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.
From 1994 onwards, anthropometric data were recorded at each clinic visit, and for the purposes of this study we used data from the first post-diagnosis clinic that usually occurred 3–4 months afterwards. Standard deviation scores (SDS) were calculated based on the British 1990 Growth Reference Data  to obtain height SDS, weight SDS, and body mass index (BMI) SDS.
In relation to perceptions and beliefs about diabetes, a significant reduction in illness identity (how much patients experience diabetes related symptoms) on the BIPQ was observed in favour of the intervention (adjusted mean difference −0.54 (95% confidence interval −1.04 to −0.03), P=0.04). However, we saw no significant group differences for perceptions of consequences, timeline, control, concern, emotions, and illness comprehensibility. A significant improvement in health status on the EQ-5D VAS was observed in favour of the intervention (4.38 (0.44 to 8.33), P=0.03) but no significant differences were observed between groups for the quality of life index score. Finally, the measure of perceived support for diabetes management showed a significant improvement between the groups in how supported the participants felt in relation to their diabetes management overall (0.26 (0.03 to 0.50), P=0.03) but no significant group differences on appraisal, emotional, and informational support.
Phoenix Health Centre carries out pre employment medical assessments for several large employers in Whakatane. These give a base line recording of an employee’s health status at the time they were employed. It is then possible to monitor the employee’s health in relation to the hazards they may be exposed to in the workplace. If required we also undertake monitored urine sampling for ESR drug testing.