Objective The Diabetes Remission Clinical Trial (DiRECT) used a formula total diet replacement programme followed by structured weight loss maintenance to induce and sustain weight loss and remission of type 2 diabetes (T2D) in 36% of participants after 2 years. Nurses and dietitians delivering DiRECT in 22 primary care practices in Tyneside and Scotland provided behavioural support to participants. Participant experiences with DiRECT highlighted the key role of support by healthcare professionals (HCPs). We evaluated HCPs' experiences with DiRECT. Research design and methods Healthcare professionals delivering DiRECT were interviewed at 12 months, while general practices (GPs) were sent an implementation questionnaire. The interviews were analysed thematically. The questionnaires were analysed using frequencies and a narrative synthesis. Results Healthcare professionals representing 11 of 22 intervention practices were interviewed and 10 of 22 GPs completed questionnaires. HCPs' initial concerns over perceived potential negative intervention effects, particularly withdrawing anti-diabetes and anti-hypertensive medications, were barriers to engagement. Trust of HCPs towards the research team and perceived credibility of the study facilitated engagement and adoption. Ongoing support by research dietitians was key to the management of participants. Involvement in DiRECT inspired more focus on behaviour modification in the treatment of other people living with T2D in routine practice. Conclusions Diabetes Remission Clinical Trial was considered highly appropriate for the management of T2D in primary care when supported by trained dietitians. Addressing limitations, including varying training needs of HCPs may improve intervention scale-up and tailoring to clinical contexts.

Introduction The Diabetes REmission Clinical Trial (DiRECT) has shown that sustained remission of type 2 diabetes in primary care is achievable through weight loss using total diet replacement (TDR) with continued behavioural support. Understanding participants' experiences can help optimise the intervention, support implementation into healthcare, and understand the process of behaviour change. Methods Thirty-four DiRECT participants were recruited into this embedded qualitative evaluation study. In-person and telephone interviews were conducted before the TDR; at week 6-8 of the TDR; 2 weeks into food reintroduction (FR); and at 1 year, to learn about participant experiences with the programme. Transcribed narratives were analysed thematically, and we used interpretation to develop overarching themes. Results Initiation of the TDR and transition to FR were challenging and required increased behavioural support. In general, adhering to TDR proved easier than the participants had anticipated. Some participants chose the optional extension of TDR. Rapid weight loss and changes in diabetes markers provided ongoing motivation. Further weight loss, behavioural support and occasional use of TDR facilitated weight loss maintenance (WLM). A process of behaviour adaptation to change following regime disruption was identified in three stages: (1) expectations of the new, (2) overcoming difficulties with adherence, and (3) acceptance of continuous effort and establishment of routines. Conclusions The DiRECT intervention was acceptable and regularity, continuity, and tailoring of behavioural support was instrumental in its implementation in primary care. The adaptation process accounts for some of the individual variability of experiences with the intervention and highlights the need for programme flexibility.

As populations grow and demand for food rises, major shifts in global agri-food policy are likely to significantly impact agricultural land use. As the UK has now separated from the Common Agricultural Policy as it left the EU, Brexit offers a unique opportunity to create UK-specific agricultural policies that may dramatically shape both the countryside’s appearance and the ecosystem services it provides. However, it is important to understand how the public – as taxpayers of agri-environment schemes – want the farmed countryside to look. To fill this knowledge gap, we undertook a novel mixed-methods study using a survey and collage-making workshops to understand aesthetic preferences for perceived “ideal” and “environmentally friendly” farm landscapes. Multinomial regression of data from a nationally representative survey of 2050 respondents demonstrated widespread support for agricultural landscapes containing trees and free-ranging livestock for ideal UK farm landscapes. Aesthetic preferences differed based on several socio-demographic variables, including gender, income and education. Landscapes with renewable energy technology, trees, and no livestock were perceived to be the most “environmentally friendly” farms, though wind turbines were visually unappealing. Eighty participants created collages of their ideal and environmentally friendly farming landscapes and completed a short survey to explain their choices. Qualitative thematic analysis of the collages and explanatory text found a desire for mosaic ideal farm landscapes focused either on agricultural or wild biological diversity. Results for the environmentally friendly farms reflected those in the survey. We discuss how our findings relate to implications for post-Brexit agricultural policy formation, particularly with regards to integrating public preferences around agri-food systems, to ensure tax-payers’ views are considered.

Aim To understand the process of behaviour change through the experiences of people with Type 2 diabetes engaged in an 8-month diabetes remission intervention including a 2-month weight loss phase with the use of a very low energy diet (VLED), and a 6-month, structured weight maintenance phase. Methods Data were collected in three semi-structured interviews at baseline, week 8 (end of the weight loss phase), and month 8 (end of the weight maintenance phase). Longitudinal inductive thematic analysis was used to analyse participants' narratives and identify change over time. Results Eleven of 18 participants completed all three interviews. The following themes of change were identified in their narratives: (1) 'Building behavioural autonomy' as a process of growing confidence to engage in health behaviours that are independent of those of other people; (2) 'Behavioural contagion' describing how one's new health behaviours tend to affect those of other people; (3) 'From rigid to flexible restraint', reflecting the changes in attitudes and behaviours required for a successful adaptation from weight loss to weight maintenance; and (4) 'Shift in identity', representing changes in the participants' perceptions of themselves. Conclusions This longitudinal qualitative study provided new insights into how behaviour change is experienced by people with Type 2 diabetes engaged on a weight management intervention using VLED, contributing to theoretical and practical understanding of weight management behaviours. The themes identify potential areas in which individuals can be supported in achieving dietary diabetes remission and long-term maintenance of weight loss.

Background The DiRECT trial assessed remission of type 2 diabetes during a primary care-led weight-management programme. At 1 year, 68 (46%) of 149 intervention participants were in remission and 36 (24%) had achieved at least 15 kg weight loss. The aim of this 2-year analysis is to assess the durability of the intervention effect. Methods DiRECT is an open-label, cluster-randomised, controlled trial done at primary care practices in the UK. Practices were randomly assigned (1:1) via a computer-generated list to provide an integrated structured weight-management programme (intervention) or best-practice care in accordance with guidelines (control), with stratification for study site (Tyneside or Scotland) and practice list size (>5700 or <= 5700 people). Allocation was concealed from the study statisticians; participants, carers, and study research assistants were aware of allocation. We recruited individuals aged 20-65 years, with less than 6 years' duration of type 2 diabetes, BMI 27-45 kg/m(2), and not receiving insulin between July 25, 2014, and Aug 5, 2016. 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 coprimary outcomes, analysed hierarchically in the intention-to-treat population at 24 months, were weight loss of at least 15 kg, and remission of diabetes, defined as HbA(1c) less than 6.5% (48 mmol/mol) after withdrawal of antidiabetes drugs at baseline (remission was determined independently at 12 and 24 months). The trial is registered with the ISRCTN registry, number 03267836, and follow-up is ongoing. Findings The intention-to-treat population consisted of 149 participants per group. At 24 months, 17 (11%) intervention participants and three (2%) control participants had weight loss of at least 15 kg (adjusted odds ratio [aOR] 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 (aOR 25.82, 8.25 to 80.84; p<0.0001). The adjusted mean difference between the control and intervention groups in change in bodyweight was -5.4 kg (95% CI -6.9 to -4.0; p<0.0001) and in HbA(1c) was -4.8 mmol/mol (-8.3 to -1.4 [-0.44% (-0.76 to -0.13)]; p=0.0063), despite only 51 (40%) of 129 patients in the intervention group using anti-diabetes medication compared with 120 (84%) of 143 in the control group. In a post-hoc analysis of the whole study population, of those participants who maintained at least 10 kg weight loss (45 of 272 with data), 29 (64%) achieved remission; 36 (24%) of 149 participants in the intervention group maintained at least 10 kg weight loss. Serious adverse events were similar to those reported at 12 months, but were fewer in the intervention group than in the control group in the second year of the study (nine vs 22). Interpretation The DiRECT programme sustained remissions at 24 months for more than a third of people with type 2 diabetes. Sustained remission was linked to the extent of sustained weight loss. Copyright (C) 2019 Elsevier Ltd. All Rights reserved.

Background: DiRECT reported diabetes remission at one year for 46% of participants allocated to an integrated structured weight management programme. We now assess two-year findings. Methods: DiRECT is an open-label, cluster-randomised, controlled trial in primary care practices randomised to a weight management programme (intervention) or best-practice care by guidelines (control). We recruited individuals aged 20–65 years, with <6 years duration of type 2 diabetes, body-mass index 27–45 kg/m, and not receiving insulin. The intervention comprised withdrawal of anti-diabetes and antihypertensive drugs, total diet replacement (825–853 kcal/day formula diet) for 12-20 weeks, stepped food reintroduction (2–8 weeks), and then structured support for weight loss maintenance. Co-primary outcomes, analysed hierarchically, were weight loss >15 kg, and remission of diabetes, defined as HbA1c <6·5% (<48 mmol/mol) with no anti-diabetes medications. Findings: At 24 months, 53/149 (35·6%) of those commencing the intervention and 5/149 (3·4%) in the control group (adjusted odds ratio 25·8, 95% CI 8·3,80·8; p<0·0001) had remission, and 11·4% of intervention and 2·0% of the control group (adjusted odds ratio 8·2 (2·2,30·0), p=0·0015) had weight loss ≥15kg. Of those maintaining ≥10kg weight loss (45/272), 64% (29/45) achieved remission, and 24.2% (36/149) of the intervention group maintained ≥10kg weight loss. Adjusted mean differences between groups were, in changes in body weight -5·4 kg, (-6·9,-4·0), p<0·0001, in HbA1c -4·8 mmol/mol, (-8·3,-1·4), p=0·0063 despite >50% fewer anti-diabetes agent use in intervention group, and SBP -3·4 mmHg, (-6·7,-0·2), p=0·0397. Serious adverse events were similar at 12 months, but fewer occurred in intervention than control in the second year (9 vs. 22). Quality of life improved more from baseline in the intervention than the control group, adjusted mean difference 4·6 (0·4,8·9, p=0·032). Interpretation: This programme sustained remissions at 24 months for over a third of people with type 2 diabetes. Weight loss of ≥10 kg provides remission for two thirds. Funding: Diabetes UK.

Aims:To provide a qualitative evaluation of a 12-week TDR stage of the DiRECT intervention delivered in UK primary care,aiming to reverse Type 2 diabetes. Methods:Participants matched for gender and socioeconomic status across trial sites were interviewed at baseline (T1), six weeks into the TDR (T2) and two weeks after food reintroduction (FR)(T3). The interviews were semi-structured, audio-recorded, transcribed verbatim and analysed using the framework approach. Results: Out of 34 intervention participants interviewed at T1, 27 were available for a follow-up at T2 and 25 were available at T3. Eight participants withdrew from the study during the TDR. Narratives of 21 participants with complete data were analysed. Desiring normality in the form of normal blood glucose levels,body mass index or the ability to wear normal clothes and eat normal food were the main drivers to taking part in the study. The TDR phase was perceived as challenging but somewhat easier than anticipated. Willpower, use of behaviour–regulation strategies,social roles, behavioural independence and social and clinical support were vital determinants of adherence. Both the TDR and FR stages required resolving cognitive and emotional goal conflicts. Transition to regular food was perceived as destabilising and required increased effort, re-designing of one’s ‘Foodrobe’ and continuous support. Summary: Experience with the weight loss stage of the DiRECT intervention for diabetes remission was positive for most participants, but clinical and social support proved essential for a successful completion.

Substantial weight loss in type 2 diabetes can achieve a return to non-diabetic biochemical status, without the need for medication. The Diabetes Remission Clinical Trial (DiRECT), a cluster-randomised controlled trial, is testing a structured intervention designed to achieve and sustain this over 2 years in a primary care setting to determine practicability for routine clinical practice. This paper reports the characteristics of the baseline cohort.

Background Type 2 diabetes is a chronic disorder that requires lifelong treatment. We aimed to assess whether intensive weight management within routine primary care would achieve remission of type 2 diabetes. Methods We did this open-label, cluster-randomised trial (DiRECT) at 49 primary care practices in Scotland and the Tyneside region of England. Practices were randomly assigned (1: 1), via a computer-generated list, to provide either a weight management programme (intervention) or best-practice care by guidelines (control), with stratification for study site (Tyneside or Scotland) and practice list size (>5700 or <= 5700). Participants, carers, and research assistants who collected outcome data were aware of group allocation; however, allocation was concealed from the study statistician. We recruited individuals aged 20-65 years who had been diagnosed with type 2 diabetes within the past 6 years, had a body-mass index of 27-45 kg/m(2), and were not receiving insulin. The intervention comprised withdrawal of antidiabetic and antihypertensive drugs, total diet replacement (825-853 kcal/day formula diet for 3-5 months), stepped food reintroduction (2-8 weeks), and structured support for long-term weight loss maintenance. Co-primary outcomes were weight loss of 15 kg or more, and remission of diabetes, defined as glycated haemoglobin (HbA(1c)) of less than 6.5% (<48 mmol/mol) after at least 2 months off all antidiabetic medications, from baseline to 12 months. These outcomes were analysed hierarchically. This trial is registered with the ISRCTN registry, number 03267836. Findings Between July 25, 2014, and Aug 5, 2017, we recruited 306 individuals from 49 intervention (n= 23) and control (n= 26) general practices; 149 participants per group comprised the intention-to-treat population. At 12 months, we recorded weight loss of 15 kg or more in 36 (24%) participants in the intervention group and no participants in the control group (p<0.0001). Diabetes remission was achieved in 68 (46%) participants in the intervention group and six (4%) participants in the control group (odds ratio 19.7, 95% CI 7.8-49.8; p<0.0001). Remission varied with weight loss in the whole study population, with achievement in none of 76 participants who gained weight, six (7%) of 89 participants who maintained 0-5 kg weight loss, 19 (34%) of 56 participants with 5-10 kg loss, 16 (57%) of 28 participants with 10-15 kg loss, and 31 (86%) of 36 participants who lost 15 kg or more. Mean bodyweight fell by 10.0 kg (SD 8.0) in the intervention group and 1.0 kg (3.7) in the control group (adjusted difference -8.8 kg, 95% CI -10.3 to -7.3; p<0.0001). Quality of life, as measured by the EuroQol 5 Dimensions visual analogue scale, improved by 7.2 points (SD 21.3) in the intervention group, and decreased by 2.9 points (15.5) in the control group (adjusted difference 6.4 points, 95% CI 2.5-10.3; p=0.0012). Nine serious adverse events were reported by seven (4%) of 157 participants in the intervention group and two were reported by two (1%) participants in the control group. Two serious adverse events (biliary colic and abdominal pain), occurring in the same participant, were deemed potentially related to the intervention. No serious adverse events led to withdrawal from the study. Interpretation Our findings show that, at 12 months, almost half of participants achieved remission to a non-diabetic state and off antidiabetic drugs. Remission of type 2 diabetes is a practical target for primary care.

AIMS:To evaluate the acceptability of an 8-week very-low-energy diet for remission of Type 2 diabetes, and to identify barriers and facilitators of adherence and behaviour-regulation strategies used by participants in the Counterbalance study. METHODS:Eighteen of 30 participants in the Counterbalance study (ISRCTN88634530) took part in semi-structured interviews. Of these, 15 participants were interviewed before and after the 8-week very-low-energy diet intervention. Thematic analysis was used to analyse the narratives. RESULTS:The prospect of diabetes remission, considerable weight loss, and long-term health improvement provided participants with substantial initial motivation. This motivation was sustained through the experience of rapid weight loss, improvements in blood glucose levels, social support and increased physical and psychological well-being. Overall, adherence to the very-low-energy diet for 8 weeks was perceived as much easier than anticipated, but required personal effort. Participants addressed challenges by removing food from the environment, planning, avoidance of tempting situations or places, and self-distraction. Weight loss and improvements in blood glucose levels lead to a sense of achievement and improvements in physical and psychological wellbeing. CONCLUSIONS:Dietary treatment for reversal of Type 2 diabetes is acceptable and feasible in motivated participants, and the process is perceived as highly gratifying. Research outside of controlled trial settings is needed to gauge the generalisability of these findings.

Despite improving evidence-based practice following clinical guidelines to optimise drug therapy, Type 2 diabetes (T2DM) still exerts a devastating toll from vascular complications and premature death. Biochemical remission of T2DM has been demonstrated with weight loss around 15kg following bariatric surgery and in several small studies of non-surgical energy-restriction treatments. The non-surgical Counterweight-Plus programme, running in Primary Care where obesity and T2DM are routinely managed, produces >15 kg weight loss in 33 % of all enrolled patients. The Diabetes UK-funded Counterpoint study suggested that this should be sufficient to reverse T2DM by removing ectopic fat in liver and pancreas, restoring first-phase insulin secretion.

AimsTo explore the efficacy and acceptability of very low energy diets in overweight or obese adults with Type 2 diabetes.MethodsControlled trials and qualitative studies of individuals with Type 2 diabetes that compared very low energy diets with standard care, minimal interventions, other weight loss interventions, less intensive very low energy diet interventions and very low energy diets with additional components were eligible for inclusion. Meta-analyses of changes in weight, blood glucose levels and attrition rates were performed. Acceptability of very low energy diets was assessed by attrition rates, number and severity of side effects, and by qualitative evaluations of the interventions.ResultsFour randomized, five non-randomized controlled trials and no qualitative studies (21 references, 9 studies, 346 participants) were identified. Meta-analyses showed that very low energy diets induced greater weight losses than minimal interventions, standard care or low energy diets at 3 and 6months. No conclusive evidence for differences in outcomes between very low energy diets and Roux-en-Y gastric bypass surgery was found. Greater differences in energy prescription between intervention and comparator arms were associated with greater differences in weight loss and fasting blood glucose levels at 3 months. Attrition rates did not differ between the very low energy diets and the comparator arms at any measurement point.ConclusionsVery low energy diets are effective in substantial weight loss among people with Type 2 diabetes. Levels of adherence to very low energy diets in controlled studies appear to be high, although details about behaviour support provided are usually poorly described.

Background: Reducing reliance on motorised transport and increasing use of more physically active modes of travel may offer an opportunity to address physical inactivity. This review evaluates the evidence for the effects of behavioural interventions to reduce car use for journeys made by adults and codes intervention development and content.Methods: The review follows the procedure stated in the registration protocol published in the PROSPERO database (registration number CRD42011001797). Controlled studies evaluating behavioural interventions to reduce car use compared with no interventions or alternative interventions on outcome measures of transport behaviours taken in adult participants are included in this review. Searches were conducted on all records in Applied Social Sciences Index and Abstracts (ASSIA), Ovid Embase, Ovid Medline, Ovid PsycInfo, Scopus, Sociological Abstracts, Transportation Research Information Service (TRIS), Transportation Research International Documentation (TRID), and Web of Science databases. Peer reviewed publications in English language meeting the inclusion criteria are eligible. Methodological quality is assessed using the Cochrane Risk of Bias Tool. Interventions are categorised in terms of behavioural frameworks, theories and techniques.Results: 15 full text articles are included, representing 13 unique studies, with 4895 participants and 27 intervention arms. Risk of bias across the review is appraised as considerable due to the unclear methodological quality of individual studies. Heterogeneity of included studies is considerable. Meta-analyses reveal no significant effect on reduction of frequency of car use or on increasing the proportion of journeys by alternative, more active modes of transport. There is insufficient data relating to alternative outcomes such as distance and duration which may have important health implications. Interventions were top-down but could not be described as theory-based. Intervention efficacy was associated with the use of a combination of information provision and behavioural regulation techniques. There was a lack of consideration of opportunity for change and behaviour in context.Conclusions: There is no evidence for the efficacy of existing behavioural interventions to reduce car trips included in this review. The evidence for efficacy of behavioural interventions to decrease distance and duration of car journeys is limited and inconclusive. Overall the evidence is highly heterogeneous and is at considerable risk of bias. Future research should investigate alternative behavioural interventions in high quality, controlled studies informed by existing evidence, theory, and viewers of potential users. Future intervention studies should increase scientific rigour, include objective outcome measures, and incorporate thorough evaluations as standard.