This study was carried out at primary care practices in the UK who were randomised to provide an integrated structured weight-management programme (intervention) or best-practice care in accordance with guidelines (control).
The intervention consisted of withdrawal of antidiabetes and antihypertensive drugs, total diet replacement (825–853 kcal per day formula diet for 12–20 weeks), stepped food reintroduction (2–8 weeks), and then structured support for weight-loss maintenance.
The two year analysis noted that 17 (11%) intervention participants and three (2%) control participants had weight loss of at least 15 kg (adjusted odds ratio 7.49, 95% CI 2.05 to 27.32; p=0.0023) and 53 (36%) intervention participants and five (3%) control participants had remission of diabetes (25.82, 8.25 to 80.84; p<0·0001), which was linked to the extent of sustained weight loss.
According to a commentary, if 25% of people with type 2 diabetes were to follow the DiRECT programme, this would result in ~ 50% increase in total nurse consultation time and therefore workforce. It questions if such intensive support is crucial, noting that a systematic review of 45 trials showed no evidence behavioural support reduced weight regain following an intensive weight-loss programme. It adds however that the DiRECT programme offered more than the advice and support to prevent weight regain that has been tested in previous trials, including the prompt offer of a further diet-replacement period or treatment with orlistat. About half of the intervention participants resumed their total diet replacement on at least one occasion, but there was still a mean of 2.6 kg weight regain between the 12-month and 24-month assessments, so further evidence is needed. It suggest that despite these questions, DiRECT should change the paradigm—remission from type 2 diabetes is possible with support from generalist clinicians and it alludes to a plan by NHS England to test total diet replacements as a treatment to induce diabetes remission as part of a broader agenda to treat weight-related diseases with active weight-loss support.