The DiRECT trial in practice
Following the positive 2-year results of DiRECT, reported earlier in the day at the Diabetes UK Professional Conference in Liverpool, this symposium shared the first-hand experiences of a dietician, a general practitioner (GP), and a person with diabetes who participated in the study. Session co-Chair Racquel Delgado, from Hounslow Clinical Commissioning Group in London, UK, said the symposium would help delegates understand how the DiRECT trial could be rolled out to practices across the country.
The dietician’s role
Presenter Louise McCombie (University of Glasgow, UK) noted that a lot of the previous focus has been on the “soups and shakes” phase of the program and the concern that a temporary lifestyle change will produce only temporary results. She said it was time for a “rallying call to dietetic colleagues to rise to the challenge”.
McCombie explained that dieticians have a three-pronged role in the trial: program development; practitioner training; and delivery of the intervention, although the latter could also be done by a practice nurse, depending on availability of resource in the area. She stressed that the “right level and timing of support [for] the [healthcare practitioners] and participants is crucial” to achieve continual motivation and therefore weight loss success. Both good communication and the ability to engage the participants in behavior change are skills required to implement this program; thus, practitioner training was a key focus.
Practitioner training involved a combination of practical training for blood pressure and glucose measurement, classroom-based training, and mentoring. The continued mentoring by a specialist consultant physician was highlighted as a core component of the training.
The practitioners were instructed to follow the one-to-one appointment schedule as detailed below:
- Total diet replacement phase: every 2 weeks for 12 weeks, with the first appointment lasting 1 hour.
- Food reintroduction phase: every 2 weeks for 6–8 weeks, with the first appointment lasting 1 hour.
- Weight loss management: every 4 weeks for 84 weeks to date.
They were also provided with guidance on the appointment content, which included:
- setting expectations and reviewing progress;
- measurements, eg, weight, blood pressure, and glucose;
- a review of the need for anti-diabetes and anti-hypertensive medication according to guidelines;
- provision of formula diet; and
- appointment workbooks to guide further discussion with the participant.
Moving on to intervention delivery, McCombie noted that there was an initial screening to check for eligibility and determine if the approach would be suitable for the individual patient, to discuss the pros and cons, and to give the patient a sample of the formula diet. She highlighted the specific considerations for each of the three intervention phases.
- Total diet replacement, which is a very important stage where behavior methods are introduced and the potential barriers are identified.
- The food reintroduction phase, which can be an anxious time for the patient; therefore, this phase should be gradual and individualized. Offering advice on portion sizes, eating behaviors, and physical activity is central.
- The final, and perhaps most complex, phase is weight loss maintenance. The key to achieving maintenance is to set expectations and develop individualized strategies, while advising the patient to expect fluctuations and how to deal with these.
McCombie highlighted the key components for successful delivery of the intervention: firstly, to minimize weight gain by enabling the patient to adopt “a new normality”; secondly, to ensure the program is delivered by competency-trained staff who are developing skills for long-term change from the outset; and thirdly, ensuring the availability of ongoing support to the patient by the trained practitioner.
“The DiRECT study is a starting point for the prevention agenda,” McCombie concluded, advising that we should learn, build, and improve upon what the study has taught us so far.
Viewpoint from the general practices
Wilma Leslie, also from the University of Glasgow, opened her presentation by highlighting the importance of clearly defining what was expected of the GP practices recruited into the DiRECT study. The participating practice had to hold responsibility for the final selection of appropriate participants, removing any patients deemed inappropriate for the intervention such as those with serious health or mental health issues and those with language barriers.
As anticipated, the GP practices expressed several concerns regarding participation.
- The withdrawal of antihypertensive and antidiabetic medication was the most commonly reported concern of GPs, particularly for their patients on more than three of these medications. Practices were reassured that blood pressure and glucose were regularly checked to ensure there were no harmful side effects to the withdrawal. There were also protocols in place to reintroduce these medications should that be required. “Clinical management and patient safety was of paramount importance,” Leslie stressed.
- Another key concern and “barrier to participation” was the burden on the practice with regard to time and resource. Moreover, as dieticians were not available in every area, there was an impact on practice nurse time and resources. Leslie explained that these issues were always discussed prior to practice recruitment.
- Skepticism about the formula of the diet replacement was a concern. Safety and the potential for the patient to experience a large increase in weight following this phase of the intervention were noted.
Despite these initial concerns, Leslie reported an overall positive response from an online GP survey following the 1-year results. The overall satisfaction with the experience of DiRECT was high. There were some reported challenges in fitting the intervention into routine practice, but Leslie commented that this was most likely at the beginning of the intervention when the initial preparations were being completed. The GPs also reported some difficulty in stopping medications; however, “no serious issues arose through withdrawal of the antihypertensive medications.” The survey results also highlighted the value of the dietetic input for the intervention delivery.
The intervention has led to a “shift into how they approach patients with type 2 diabetes in their routine practice,” said Leslie, with a move toward more lifestyle and diet modification at the early stages of diagnosis. However, there was a note of caution that it is not the “panacea” of treatment.
The survey also revealed an impact on patients who were not on the intervention, whereby those not in the trial or in the control group wanted to be involved with the hope of also achieving remission.
Looking to the future, Leslie expressed her hope that DiRECT will be a country-wide option for the first-line management of type 2 diabetes. Yet she acknowledged that key issues need to be resolved first, including an improvement in dietetic input and greater support and training for practice nurses.
The Scottish Care Information Diabetes database recorded an increase of the number diabetes patients in remission from 251 in 2017 to 1328 currently, indicating that “changes are afoot,” concluded Leslie.
A patient’s experience of the DiRECT trial
Joseph McSorley, from Paisley, UK, provided a first-hand patient experience of DiRECT. He explained how, contrary to some participants’ opinions, he found the initial diet replacement phase of the program the easiest. He explained that knowing the “route was already plotted out” made it easier to adhere to, resulting in him losing 20 kg in the first 12 weeks. “That wouldn’t have been possible to achieve that without the support from the DiRECT team,” he explained, which he received on the advised schedule of every 2 weeks.
“This trial itself is not a cure for type 2 diabetes,” he pointed out, highlighting the importance of patient motivation to the success of the intervention. Following completion of the first phase is where the true challenges begin whereby solid food is being reintroduced. Portion control was crucial in this and managing patients’ anxiety about putting the weight back on. McSorley detailed that the gradual reintroduction over 3–4 weeks and a regular exercise regimen helped him manage these worries. Nonetheless there was a contingency plan developed with the DiRECT team to reintroduce the shakes should he notice any weight increase.
The DiRECT study not only enabled a weight reduction; McSorley listed several conditions that had improved since participating in the trial, including allergies, irritable bowel syndrome symptoms, and psoriasis.
He concluded by acknowledging that the intervention wasn’t “for everyone” and that you had to be motivated to follow the program through.
Taking advantage of peer support
During the audience discussions, a delegate asked if DiRECT could be delivered in a group setting, which McCombie agreed should be considered, noting that it could provide additional peer-to-peer support and reduces the burden on practice nurse resource.
And a dietician from the audience endorsed the support of the participants’ partners and families in the success of weight management plans, highlighting the ramifications a weight loss plan can have on any cohabitants, particularly children. He further added that it is crucial for the practitioners to “tap into the support that patients bring to each other”.
In response, Roy Taylor (Newcastle University, UK), one of the DiRECT study leads, concurred from the audience that the initial input of the spouse was crucial and from his experience the “power was coming from next door.”
By Rebecca Cox
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