REduced-Carbohydrate intervention for managing Obesity and Reduction of gestational Diabetes (RECORD): A randomized controlled feasibility trial.

AIM: To test the feasibility and acceptability of a reduced-carbohydrate dietary program, intended to reduce the risk of gestational diabetes. MATERIALS AND METHODS: Fifty-one pregnant women at <20 weeks' gestation, with body mass index ≥30 kg/m2 , and a normal baseline oral glucose tolerance test (OGTT), were randomized 2:1 to an intervention or control group and followed-up until delivery. The dietary intervention aimed at providing 130-150 g carbohydrate/day. Feasibility outcomes assessed at 24-28 weeks' gestation, included adoption of the reduced-carbohydrate diet by the intervention group, and retention of all participants, assessed by completion of a second OGTT. Changes in glycemia, weight gain and dietary intake, and the maternal and neonatal outcomes were also assessed. Participants were interviewed about their experience of the intervention and the study. RESULTS: Forty-nine of 51 participants attended the follow-up OGTT, a retention rate of 96% (95% confidence interval [CI] 86.8%-98.9%). In the intervention group, carbohydrate intake at follow-up was 190.4 (95% CI 162.5-215.6) g/day, a reduction of -24.6 (95% CI -51.5-2.4) g/day from baseline. Potentially favourable effects of the intervention on glucose control, weight gain and blood pressure were observed, but the study was not powered to detect significant differences in these. Participants found the intervention acceptable, and were content with the study processes, but some reported barriers to sustained adherence, mainly pertaining to competing priorities. CONCLUSIONS: Retention was high, suggesting the study processes are feasible, but the carbohydrate reduction in the intervention group was small, and did not meet progression criteria, limiting the likelihood of achieving the desired goal to prevent gestational diabetes. TRIAL REGISTRATION NUMBER: ISRCTN16235884.

Dietary intervention in gestational diabetes: a qualitative study of the acceptability and feasibility of a novel whole-diet intervention in healthcare professionals.

Gestational diabetes is treated with medical nutrition therapy, delivered by healthcare professionals; however, the optimal diet for affected women is unknown. Randomised controlled trials, such as the DiGest (Dietary Intervention in Gestational Diabetes) trial, will address this knowledge gap, but the acceptability of whole-diet interventions in pregnancy is unclear. Whole-diet approaches reduce bias but require high levels of participant commitment and long intervention periods to generate meaningful clinical outcomes. We aimed to assess healthcare professionals' views on the acceptability of the DiGest dietbox intervention for women with gestational diabetes and to identify any barriers to adherence which could be addressed to support good recruitment and retention to the DiGest trial. Female healthcare professionals (n 16) were randomly allocated to receive a DiGest dietbox containing 1200 or 2000 kcal/d including at least one weeks' food. A semi-structured interview was conducted to explore participants' experience of the intervention. Interviews were audio-recorded, transcribed verbatim and analysed thematically using NVivo software. Based on the findings of qualitative interviews, modifications were made to the dietboxes. Participants found the dietboxes convenient and enjoyed the variety and taste of the meals. Factors which facilitated adherence included participants having a good understanding of study aims and sufficient organisational skills to facilitate weekly meal planning in advance. Barriers to adherence included peer pressure during social occasions and feelings of deprivation or hunger (affecting both standard and reduced calorie groups). Healthcare professionals considered random allocation to a whole-diet replacement intervention to be acceptable and feasible in a clinical environment and offered benefits to participants including convenience.

Dietary Approaches to the Management Of type 2 Diabetes (DIAMOND) in primary care: A protocol for a cluster randomised trial.

INTRODUCTION: There is strong evidence that type 2 diabetes (T2D) remission can be achieved by adopting a low-energy diet achieved through total dietary replacement products. There is promising evidence that low-carbohydrate diets can achieve remission of T2D. The Dietary Approaches to the Management of type 2 Diabetes (DIAMOND) programme combines both approaches in a behaviourally informed low-energy, low-carbohydrate diet for people with T2D, delivered by nurses in primary care. This trial compares the effectiveness of the DIAMOND programme to usual care in inducing remission of T2D and in reducing risk of cardiovascular disease. METHODS AND ANALYSIS: We aim to recruit 508 people in 56 practices with T2D diagnosed within 6 years, who are demographically representative of the UK population. We will allocate general practices, based on ethnicity and socioeconomic status, to provide usual care for diabetes or offer the DIAMOND programme. Participants in practices offering DIAMOND will see the nurse seven times over 6 months. At baseline, 6 months, and 1 year we will measure weight, blood pressure, HbA1c, lipid profile and risk of fatty liver disease. The primary outcome is diabetes remission at 1 year, defined as HbA1c < 48 mmol/mol and off glucose-lowering medication for at least 6 months. Thereafter, we will assess whether people resume treatment for diabetes and the incidence of microvascular and macrovascular disease through the National Diabetes Audit. Data will be analysed using mixed-effects generalised linear models. This study has been approved by the National Health Service Health Research Authority Research Ethics Committee (Ref: 22/EM/0074). TRIAL REGISTRATION NUMBER: ISRCTN46961767.

Development and testing of a reduced carbohydrate intervention for the management of obesity and reduction of gestational diabetes (RECORD): protocol for a feasibility randomised controlled trial.

INTRODUCTION: Previous trials of dietary interventions to prevent gestational diabetes mellitus (GDM) have yielded only limited success. Low-carbohydrate diets have shown promise for the treatment of type 2 diabetes, but there is no evidence to support their use in pregnancy. The aim of this study is to explore the feasibility of a moderately reduced-carbohydrate dietary intervention delivered from mid-pregnancy alongside routine antenatal care. METHODS AND ANALYSIS: This is a feasibility randomised controlled trial (RCT) with embedded qualitative study. Sixty women who are pregnant <20 weeks' gestation, with body mass index ≥30 kg/m2 at their antenatal booking appointment, will be randomised 2:1 intervention or control (usual care) and followed up until delivery. The intervention is a moderately reduced-carbohydrate diet (~130-150 g total carbohydrate/day), designed to be delivered alongside routine antenatal appointments. Primary outcomes are measures of adoption of the diet and retention of participants. Secondary outcomes include incidence of GDM, change in markers of glycaemic control, gestational weight gain, total carbohydrate and energy intake. Process outcomes will examine resources and management issues. Exploratory outcomes include further dietary changes, quality of life, maternal and neonatal outcomes, and qualitative measures. ETHICS AND DISSEMINATION: This trial was reviewed and approved by the South-Central Oxford B Research Ethics Committee NHS National Research Ethics Committee and the Health Research Authority (Reference: 20/SC/0442). The study results will inform whether to progress to a full-scale RCT to test the clinical effectiveness of the RECORD programme to prevent GDM in women at high risk. The findings will be published in peer-reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER: ISRCTN16235884.

Study protocol: use of a smartphone application to support the implementation of a complex physical activity intervention (+Stay Active) in women with gestational diabetes mellitus-protocol for a non-randomised feasibility study.

INTRODUCTION: Physical activity (PA) interventions have a promising role in the management of gestational diabetes mellitus (GDM). Digital technologies can support PA at scale and remotely. The protocol describes a study designed to determine the feasibility and acceptability of a complex intervention; known as +Stay Active. +Stay Active combines motivational interviewing with a bespoke behaviour change informed smartphone application (Stay-Active) to augment PA levels in women with GDM. METHODS AND ANALYSIS: This is a non-randomised feasibility study using a mixed methods approach. Participants will be recruited from the GDM antenatal clinic at the Women Centre, John Radcliffe Hospital, Oxford. Following baseline assessments (visit 1) including self-reported and device determined PA assessment (wearing a wrist accelerometer), women will be invited to participate in an online motivational interview, then download and use the Stay-Active app (Android or iOS) (visit 2). Women will have access to Stay-Active until 36 weeks gestation, when engagement and PA levels will be reassessed (visit 3). The target sample size is 60 women. Primary outcomes are recruitment and retention rates, compliance and assessment of participant engagement and acceptability with the intervention. Secondary outcomes are assessment of blood glucose control, self-reported and device determined assessment of PA, usage and structured feedback of participant's attitudes to +Stay Active, assessment of health costs and description of maternal and neonatal outcomes. This study will provide key insights into this complex intervention regarding engagement in smartphone technology and the wearing of accelerometers. These data will inform the development of a randomised controlled trial with refinements to intervention implementation. ETHICS AND DISSEMINATION: The study has received a favourable opinion from South Central-Hampshire B Research Ethics Committee; REC reference: 20/SC/0342. Written informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed journals, conferences and seminar presentations. TRIAL REGISTRATION NUMBER: ISRCTN11366562.

The Harry Keen Rank Nutrition Lecture 2022. Nutritional guidelines for diabetes management: Where do they come from and do they work?

Nutritional guidelines for diabetes are designed to support those living with diabetes in achieving optimal glycaemic control, reducing the risk of cardiovascular disease and maintaining quality of life. Historically, guidelines reflected current opinion and clinical practice and only relatively recently have evidence-based recommendations been published. Current nutritional guidelines for type 1 and type 2 diabetes are based on high-quality evidence including data from randomised controlled trials and prospective cohort studies and are graded by the strength of evidence. There is no evidence to support one specific dietary strategy for people with diabetes, and this is particularly true for weight reduction in those with type 2 diabetes living with overweight or obesity, where the evidence suggests that different strategies are equally successful. As a result, the emphasis of modern guidelines is on individualised, person-centred approaches. Some barriers to successful implementation include lack of dietary education and knowledge in health professionals supporting people with diabetes, and a so-called obesogenic environment that impedes dietary change. Initiatives such as education and training programmes for health professionals, and population-based interventions that promote both structural and policy change are recommended to enable those with diabetes to support dietary change and improve health.

Lower carbohydrate diets for adults with type 2 diabetes.

In May 2021, the Scientific Advisory Committee on Nutrition (SACN) published a risk assessment on lower carbohydrate diets for adults with type 2 diabetes (T2D)(). The purpose of the report was to review the evidence on 'low'-carbohydrate diets compared with the current UK government advice on carbohydrate intake for adults with T2D. However, since there is no agreed and widely utilised definition of a 'low'-carbohydrate diet, comparisons in the report were between lower and higher carbohydrate diets. SACN's remit is to assess the risks and benefits of nutrients, dietary patterns, food or food components for health by evaluating scientific evidence and to make dietary recommendations for the UK based on its assessment(). SACN has a public health focus and only considers evidence in healthy populations unless specifically requested to do otherwise. Since the Committee does not usually make recommendations relating to clinical conditions, a joint working group (WG) was established in 2017 to consider this issue. The WG comprised members of SACN and members nominated by Diabetes UK, the British Dietetic Association, Royal College of Physicians and Royal College of General Practitioners. Representatives from NHS England and NHS Health Improvement, the National Institute for Health and Care Excellence and devolved health departments were also invited to observe the WG. The WG was jointly chaired by SACN and Diabetes UK.

The influence of nutritional state on the fatty acid composition of circulating lipid fractions: implications for their use as biomarkers of dietary fat intake.

BACKGROUND: The fatty acid (FA) composition of blood can be used as an objective biomarker of dietary FA intake. It remains unclear how the nutritional state influences the FA composition of plasma lipid fractions, and thus their usefulness as biomarkers in a non-fasted state. OBJECTIVES: To investigate the associations between palmitate, oleate and linoleate in plasma lipid fractions and self-reported dietary FA intake, and assess the influence of meal consumption on the relative abundance of these FA in plasma lipid fractions (i.e. triglyceride [TG], phospholipids [PLs] and cholesterol esters [CEs]). DESIGN: Analysis was performed in plasma samples collected from 49 (34 males and 15 females) participants aged 26-57 years with a body mass index (BMI) between 21.6 and 34.2 kg/m2, all of whom had participated in multiple study visits, thus a pooled cohort of 98 data sets was available for analysis. A subset (n = 25) had undergone nutritional interventions and was therefore used to investigate the relationship between the FA composition of plasma lipid fractions and dietary fat intake. RESULTS: Significant (P < 0.05) positive associations were observed between dietary polyunsaturated fat and linoleate abundance in plasma CE. When investigating the influence of meal consumption on postprandial FA composition, we found plasma TG palmitate significantly (P < 0.05) decreased across the postprandial period, whereas oleate and linoleate increased. A similar pattern was observed in plasma PL, whereas linoleate abundance decreased in the plasma CE. CONCLUSION: Our data demonstrate that the FA composition of plasma CE may be the lipid fraction to utilise as an objective biomarker when investigating recent (i.e. previous weeks-months) dietary FA intakes. In addition, we show that the consumption of a high-fat meal influences the FA composition of plasma TG, PL and CE over the course of the postprandial period, and therefore, suggest that fasting blood samples should be utilised when using FA composition as a biomarker of dietary FA intake.

Intrahepatic Fat and Postprandial Glycemia Increase After Consumption of a Diet Enriched in Saturated Fat Compared With Free Sugars.

OBJECTIVE: Debate continues regarding the influence of dietary fats and sugars on the risk of developing metabolic diseases, including insulin resistance and nonalcoholic fatty liver disease (NAFLD). We investigated the effect of two eucaloric diets, one enriched with saturated fat (SFA) and the other enriched with free sugars (SUGAR), on intrahepatic triacylglycerol (IHTAG) content, hepatic de novo lipogenesis (DNL), and whole-body postprandial metabolism in overweight males. RESEARCH DESIGN AND METHODS: Sixteen overweight males were randomized to consume the SFA or SUGAR diet for 4 weeks before consuming the alternate diet after a 7-week washout period. The metabolic effects of the respective diets on IHTAG content, hepatic DNL, and whole-body metabolism were investigated using imaging techniques and metabolic substrates labeled with stable-isotope tracers. RESULTS: Consumption of the SFA diet significantly increased IHTAG by mean ± SEM 39.0 ± 10.0%, while after the SUGAR diet IHTAG was virtually unchanged. Consumption of the SFA diet induced an exaggerated postprandial glucose and insulin response to a standardized test meal compared with SUGAR. Although whole-body fat oxidation, lipolysis, and DNL were similar following the two diets, consumption of the SUGAR diet resulted in significant (P < 0.05) decreases in plasma total, HDL, and non-HDL cholesterol and fasting ß-hydroxybutyrate plasma concentrations. CONCLUSIONS: Consumption of an SFA diet had a potent effect, increasing IHTAG together with exaggerating postprandial glycemia. The SUGAR diet did not influence IHTAG and induced minor metabolic changes. Our findings indicate that a diet enriched in SFA is more harmful to metabolic health than a diet enriched in free sugars.

A food-based, low-energy, low-carbohydrate diet for people with type 2 diabetes in primary care: A randomized controlled feasibility trial.

AIM: To examine the feasibility of a food-based, low-energy, low-carbohydrate diet with behavioural support delivered by practice nurses for patients with type 2 diabetes. MATERIALS AND METHODS: People with type 2 diabetes and a body mass index (BMI) of ≥30 kg/m2 were randomized 2:1 to intervention or control (usual care) and assessed at 12 weeks. The intervention comprised an 800-1000 kcal/day, food-based, low-carbohydrate (<26% energy) diet for 8 weeks, followed by a 4-week weight maintenance period and four 15-20-minute appointments with a nurse. Primary outcomes were feasibility of recruitment, fidelity of intervention delivery and retention of participants at 12 weeks. Secondary outcomes included change in weight and HbA1c. Focus groups explored the intervention experience. RESULTS: Forty-eight people were screened, 33 enrolled and 32 followed-up. Mean (±SD) weight loss in the intervention group was 9.5 kg (± 5.4 kg) compared with 2 kg (± 2.5 kg) in the control group (adjusted difference - 7.5 kg [-11.0 to -4.0, P < 0.001]). Mean reduction in HbA1c in the intervention group was 16.3 mmol/mol (± 13.3 mmol/mol) compared with 0.7 mmol/mol (±4.5 mmol/mol) in the control group (difference - 15.7 mmol/mol [-24.1 to -7.3, P < 0.001]). CONCLUSIONS: It is feasible to recruit participants to a food-based, low-energy, low-carbohydrate intervention, for practice nurses to deliver the programme in primary care, and to retain participants in both groups. There is evidence of clinically significant short-term improvements in weight and glycaemic control.

Correction to: A Practical Guide to Delivering Nutritional Advice to People with Diabetes.

In the original publication, part of acknowledgement text was missing and it should read.

A Practical Guide to Delivering Nutritional Advice to People with Diabetes.

Dietary advice is fundamental to the management of diabetes. Although ideally such advice should be delivered by a state-registered dietitian, it is more usually delivered by other health professionals. The primary focus for those with type 1 diabetes is carbohydrate counting and insulin adjustment and for the majority of people with type 2 diabetes, weight management is key. Patient-centred care is emphasised for the delivery of dietary advice. It is widely recognised that knowledge alone is not sufficient to induce behaviour change and practical approaches to a variety of behavioural interventions are discussed.

Dietary Approaches to the Management Of type 2 Diabetes (DIAMOND): protocol for a randomised feasibility trial.

INTRODUCTION: Some clinicians have observed that low-carbohydrate, low-energy diets can improve blood glucose control, with reports of remission from type 2 diabetes in some patients. In clinical trials, support for low-carbohydrate, low-energy diets has been provided by specialist staff and these programmes are unsuitable for widespread deployment in routine primary care. The aim of this trial is to test whether a newly developed behavioural support programme can effectively deliver a low-energy, low-carbohydrate diet in a primary care setting. METHODS AND ANALYSIS: This is a feasibility randomised controlled trial (RCT) with embedded qualitative study. Thirty adult patients with type 2 diabetes and body mass index ≥30 kg/m2 in 2-4 general practices will be randomised 2:1 intervention or control and followed up over 12 weeks. The intervention diet comprises 8 weeks of a low-carbohydrate food-based diet providing around 800 kcal/day, followed by 4 weeks of weight maintenance. This programme will be delivered by practice nurses, who will also support patients through goal-setting, motivation and self-monitoring across four appointments, and provide a self-help booklet with recipes, shopping lists and other behavioural support. Primary outcome measures of feasibility will be met if CIs do not cross the following proportions: that 60% of intervention group participants attempt the dietary intervention, healthcare professionals conduct the intervention delivery session with at least 60% of essential elements present and 60% of participants attend the final follow-up session. Secondary outcome measures will assess process and qualitative measures, as well as exploratory outcomes including change in haemoglobin A1c and change in weight. ETHICS AND DISSEMINATION: This study has been granted ethical approval by the National Research Ethics Service, South Central Oxford B Research Ethics Committee (ref: 18/SC/0071). The study results will inform whether to progress to a full-scale RCT to test the efficacy of offering this programme for patients with type 2 diabetes in primary care. TRIAL REGISTRATION NUMBER: ISRCTN62452621; Pre-results.

Diabetes and Diet: A Patient and Dietitian's Perspective.

This article has been co-authored by a patient with type 2 diabetes and a specialist dietitian. Here they discuss the patient's experience and difficulties with controlling weight and strategies that can help a patient in this situation. The patient discusses how stress and her corresponding comfort eating dampened weight loss progress, and how adopting a lifestyle change aided through group support helped to deal with this. The physician discusses the importance of recognizing the mental and physical challenges faced by patients in this situation.

Community Interventions for Health can support clinicians in advising patients to reduce tobacco use, improve dietary intake and increase physical activity.

AIMS AND OBJECTIVES: To increase clinical interventions to reduce modifiable risk factors for noncommunicable disease in low- and middle-income countries. BACKGROUND: Noncommunicable disease is the leading cause of death in the world and is common in low- and middle-income countries. Risk factors for noncommunicable disease are modifiable and health professionals are in an unique position to intervene and influence them. DESIGN: Clinical interventions were used as part of the Community Interventions for Health programme, a nonrandomised, controlled study undertaken in three communities - one each in China, India and Mexico. METHODS: All clinicians in intervention and control areas of the study were invited to complete surveys. A total of 2280 completed surveys at baseline and 2501 at follow-up. Culturally appropriate interventions to reduce tobacco use, improve dietary intake and increase physical activity were delivered in the intervention areas. RESULTS: Clinicians in the intervention group felt more prepared to advise smoking cessation and improvement of diet. They were more likely to test serum cholesterol and blood pressure, but less likely to take measurements of height, hip, waist and skin-fold thickness. There were more resources available to clinicians in the intervention group and they used counselling more and complementary medicine less than those in the control group. CONCLUSIONS: Community interventions which have been shown to have a positive effect in the community and workplace also change clinical practice. RELEVANCE TO CLINICAL PRACTICE: Community interventions make clinicians, including nurses, more likely to feel prepared to offer advice and more likely to use counselling. This would be expected to reduce risk factors in patients.

Low Carbohydrate Diets and Type 2 Diabetes: What is the Latest Evidence?

INTRODUCTION: Low carbohydrate diets are again in the spotlight and have been identified as particularly appropriate for people with type 2 diabetes. There is confusion amongst both health professionals and people with diabetes about the suitability of these diets. This review aims to provide an overview of the latest evidence and to explore the role of low carbohydrate diets for people with type 2 diabetes. METHODS: An electronic search of English language articles was performed using MEDLINE (2010-May 2015), EMBASE (2010-May 2015), and the Cochrane Central Register of Controlled Trials (2010-May 2015). Only randomized controlled trials comparing interventions evaluating reduced carbohydrate intake with higher carbohydrate intake in people with diagnosed type 2 diabetes were included. Primary outcomes included weight, glycated hemoglobin, and lipid concentrations. RESULTS: Low carbohydrate diets in people with type 2 diabetes were effective for short-term improvements in glycemic control, weight loss, and cardiovascular risk, but this was not sustained over the longer term. Overall, low carbohydrate diets failed to show superiority over higher carbohydrate intakes for any of the measures evaluated including weight loss, glycemic control, lipid concentrations, blood pressure, and compliance with treatment. CONCLUSION: Recent studies suggest that low carbohydrate diets appear to be safe and effective over the short term, but show no statistical differences from control diets with higher carbohydrate content and cannot be recommended as the default treatment for people with type 2 diabetes.

Successful up-scaled population interventions to reduce risk factors for non-communicable disease in adults: results from the International Community Interventions for Health (CIH) Project in China, India and Mexico.

BACKGROUND: Non-communicable disease (NCD) is increasing rapidly in low and middle-income countries (LMIC), and is associated with tobacco use, unhealthy diet and physical inactivity. There is little evidence for up-scaled interventions at the population level to reduce risk in LMIC. METHODS: The Community Interventions for Health (CIH) program was a population-scale community intervention study with comparator population group undertaken in communities in China, India, and Mexico, each with populations between 150,000-250,000. Culturally appropriate interventions were delivered over 18-24 months. Two independent cross-sectional surveys of a stratified sample of adults aged 18-64 years were conducted at baseline and follow-up. RESULTS: A total of 6,194 adults completed surveys at baseline, and 6,022 at follow-up. The proportion meeting physical activity recommendations decreased significantly in the control group (C) (44.1 to 30.2%), but not in the intervention group (I) (38.0 to 36.1%), p<0.001. Those eating ≥ 5 portions of fruit and vegetables daily decreased significantly in C (19.2 to 17.2%), but did not change in I (20.0 to 19.6%,), p=0.013. The proportion adding salt to food was unchanged in C (24.9 to 25.3%) and decreased in I (25.9 to 19.6%), p<0.001. Prevalence of obesity increased in C (8.3 to 11.2%), with no change in I (8.6 to 9.7%,) p=0.092. Concerning tobacco, for men the difference-in-difference analysis showed that the reduction in use was significantly greater in I compared to C (p=0.014). CONCLUSIONS: Up-scaling known health promoting interventions designed to reduce the incidence of NCD in whole communities in LMIC is feasible, and has measurable beneficial outcomes on risk factors for NCD, namely tobacco use, diet, and physical inactivity.