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.

Experiences of emotional eating in an Acceptance and Commitment Therapy based weight management intervention (SWiM): A qualitative study.

BACKGROUND: Emotional eating is a barrier to weight management. Interventions based on Acceptance and Commitment Therapy (ACT) promote the acceptance of uncomfortable feelings, which can reduce the urge to use food as a coping mechanism. We aimed to explore how participants of an ACT-based weight management intervention (WMI) experience emotional eating and relevant intervention content. METHODS: We conducted semi-structured telephone interviews with participants of a digital ACT-based guided self-help WMI. Fifteen participants were purposefully selected to represent a range of demographic characteristics and emotional eating scores. We used reflexive thematic analysis to explore experiences of emotional eating. RESULTS: We generated five themes. Participants improved emotional eating by disconnecting emotions from behaviours though increased self-awareness (theme 1) and by implementing alternative coping strategies, including preparation, substitution, and acceptance (theme 2). Most participants maintained improvements in emotional eating over time but wished for more opportunities to re-engage with intervention content, including more immediate support in triggering situations (theme 3). Participants who struggled to engage with emotional eating related intervention content often displayed an external locus of control over emotional eating triggers (theme 4). The perceived usefulness of the intervention depended on participants' prior experiences of emotional eating, and was thought insufficient for participants with complex emotional experiences (theme 5). DISCUSSION: This ACT-based WMI helped participants with emotional eating by improving self-awareness and teaching alternative coping strategies. Intervention developers may consider adding ongoing forms of intervention that provide both real-time and long-term support. Additionally, a better understanding of how to support people with an external locus of control and people with complex experiences of emotional eating is needed. Future research may explore ways of personalising WMIs based on participants' emotional needs.

Supporting Weight Management during COVID-19 (SWiM-C): twelve-month follow-up of a randomised controlled trial of a web-based, ACT-based, guided self-help intervention.

OBJECTIVES: We developed a guided self-help intervention (Supporting Weight Management during COVID-19, "SWiM-C") to support adults with overweight or obesity in their weight management during the COVID-19 pandemic. This parallel, two-group trial (ISRCTN12107048) evaluated the effect of SWiM-C on weight and determinants of weight management over twelve months. METHODS: Participants (≥18 years, body-mass-index ≥25 kg/m2) were randomised to the SWiM-C intervention or to a standard advice group (unblinded). Participants completed online questionnaires at baseline, four months, and twelve months. The primary outcome was change in self-reported weight from baseline to twelve months; secondary outcomes were eating behaviour (uncontrolled eating, emotional eating, cognitive restraint of food intake), experiential avoidance, depression, anxiety, stress, wellbeing and physical activity. INTERVENTIONS: SWiM-C is based on acceptance and commitment therapy (ACT). Participants had access to an online web platform with 12 weekly modules and email and telephone contact with a trained, non-specialist coach. Standard advice was a leaflet on managing weight and mood during the COVID-19 pandemic. RESULTS: 388 participants were randomised (SWiM-C: n = 192, standard advice: n = 196). The baseline-adjusted difference in weight change between SWiM-C (n = 119) and standard advice (n = 147) was -0.81 kg (95% CI: -2.24 to 0.61 kg). SWiM-C participants reported a reduction in experiential avoidance (-2.45 [scale:10-70], 95% CI: -4.75 to -0.15), uncontrolled eating (-3.36 [scale: 0-100], 95% CI: -5.66 to -1.06), and emotional eating (-4.14 [scale:0-100], 95% CI: -7.25 to -1.02) and an increase in physical activity (8.96 [MET-min/week], 95% CI: 0.29 to 17.62) compared to standard advice participants. We found no evidence of an effect on remaining outcomes. No adverse events/side effects were reported. CONCLUSIONS: Whilst we were unable to conclude that the intervention had an effect on weight, SWiM-C improved eating behaviours, experiential avoidance and physical activity. Further refinement of the intervention is necessary to ensure meaningful effects on weight prior to implementation in practice. TRIAL REGISTRATION NUMBER: ISRCTN 12107048.

Preventing type 2 diabetes: A research agenda for behavioural science.

AIMS: The aim of this narrative review was to identify important knowledge gaps in behavioural science relating to type 2 diabetes prevention, to inform future research in the field. METHODS: Seven researchers who have published behaviour science research applied to type 2 diabetes prevention independently identified several important gaps in knowledge. They met to discuss these and to generate recommendations to advance research in behavioural science of type 2 diabetes prevention. RESULTS: A total of 21 overlapping recommendations for a research agenda were identified. These covered issues within the following broad categories: (a) evidencing the impact of whole population approaches to type 2 diabetes prevention, (b) understanding the utility of disease-specific approaches to type 2 diabetes prevention such as Diabetes Prevention Programmes (DPPs) compared to generic weight loss programmes, (c) identifying how best to increase reach and engagement of DPPs, whilst avoiding exacerbating inequalities, (d) the need to understand mechanism of DPPs, (e) the need to understand how to increase maintenance of changes as part of or following DPPs, (f) the need to assess the feasibility and effectiveness of alternative approaches to the typical self-regulation approaches that are most commonly used, and (g) the need to address emotional aspects of DPPs, to promote effectiveness and avoid harms. CONCLUSIONS: There is a clear role for behavioural science in informing interventions to prevent people from developing type 2 diabetes, based on strong evidence of reach, effectiveness and cost-effectiveness. This review identifies key priorities for research needed to improve existing interventions.

The need for future research into the assessment and monitoring of eating disorder risk in the context of obesity treatment.

In adolescents and adults, the co-occurrence of eating disorders and overweight or obesity is continuing to increase, and the prevalence of eating disorders is higher in people with higher weight compared to those with lower weight. People with an eating disorder with higher weight are more likely to present for weight loss than for eating disorder treatment. However, there are no clinical practice guidelines on how to screen, assess, and monitor eating disorder risk in the context of obesity treatment. In this article, we first summarize current challenges and knowledge gaps related to the identification and assessment of eating disorder risk and symptoms in people with higher weight seeking obesity treatment. Specifically, we discuss considerations relating to the validation of current self-report measures, dietary restraint, body dissatisfaction, binge eating, and how change in eating disorder risk can be measured in this setting. Second, we propose avenues for further research to guide the development and implementation of clinical and research protocols for the identification and assessment of eating disorders in people with higher weight in the context of obesity treatment. PUBLIC SIGNIFICANCE: The number of people with both eating disorders and higher weight is increasing. Currently, there is little guidance for clinicians and researchers about how to identify and monitor risk of eating disorders in people with higher weight. We present limitations of current research and suggest future avenues for research to enhance care for people living with higher weight with eating disorders.

Eating Disorders In weight-related Therapy (EDIT) Collaboration: rationale and study design.

The cornerstone of obesity treatment is behavioural weight management, resulting in significant improvements in cardio-metabolic and psychosocial health. However, there is ongoing concern that dietary interventions used for weight management may precipitate the development of eating disorders. Systematic reviews demonstrate that, while for most participants medically supervised obesity treatment improves risk scores related to eating disorders, a subset of people who undergo obesity treatment may have poor outcomes for eating disorders. This review summarises the background and rationale for the formation of the Eating Disorders In weight-related Therapy (EDIT) Collaboration. The EDIT Collaboration will explore the complex risk factor interactions that precede changes to eating disorder risk following weight management. In this review, we also outline the programme of work and design of studies for the EDIT Collaboration, including expected knowledge gains. The EDIT studies explore risk factors and the interactions between them using individual-level data from international weight management trials. Combining all available data on eating disorder risk from weight management trials will allow sufficient sample size to interrogate our hypothesis: that individuals undertaking weight management interventions will vary in their eating disorder risk profile, on the basis of personal characteristics and intervention strategies available to them. The collaboration includes the integration of health consumers in project development and translation. An important knowledge gain from this project is a comprehensive understanding of the impact of weight management interventions on eating disorder risk.

Association between weight change and incidence of cardiovascular disease events and mortality among adults with type 2 diabetes: a systematic review of observational studies and behavioural intervention trials.

AIMS/HYPOTHESIS: Weight loss is often recommended in the treatment of type 2 diabetes. While evidence has shown that large weight loss may lead to diabetes remission and improvement in cardiovascular risk factors, long-term impacts are unclear. We performed a systematic review of studies of weight loss and other weight changes and incidence of CVD among people with type 2 diabetes. METHODS: Observational studies of behavioural (non-surgical and non-pharmaceutical) weight changes and CVD events among adults with type 2 diabetes, and trials of behavioural interventions targeting weight loss, were identified through searches of MEDLINE, EMBASE, Web of Science, CINAHL, and The Cochrane Library (CENTRAL) until 9 July 2019. Included studies reported change in weight and CVD and/or mortality outcomes among adults with type 2 diabetes. We performed a narrative synthesis of observational studies and meta-analysis of trial data. RESULTS: Of 13,227 identified articles, 17 (14 observational studies, three trials) met inclusion criteria. Weight gain (vs no change) was associated with higher hazard of CVD events (HRs [95% CIs] ranged from 1.13 [1.00, 1.29] to 1.63 [1.11, 2.39]) and all-cause mortality (HRs [95% CIs] ranged from 1.26 [1.12, 1.41] to 1.57 [1.33, 1.85]). Unintentional weight loss (vs no change) was associated with higher risks of all-cause mortality, but associations with intentional weight loss were unclear. Behavioural interventions targeting weight loss showed no effect on CVD events (pooled HR [95% CI] 0.95 [0.71, 1.27]; I2 = 50.1%). Risk of bias was moderate in most studies and was high in three studies, due to potential uncontrolled confounding and method of weight assessment. CONCLUSIONS/INTERPRETATION: Weight gain is associated with increased risks of CVD and mortality, although there is a lack of data supporting behavioural weight-loss interventions for CVD prevention among adults with type 2 diabetes. Long-term follow-up of behavioural intervention studies is needed to understand effects on CVD and mortality and to inform policy concerning weight management advice and support for people with diabetes. PROSPERO registration CRD42019127304.

Perceived weight-related stigma, loneliness, and mental wellbeing during COVID-19 in people with obesity: A cross-sectional study from ten European countries.

BACKGROUND: Increased weight-related stigma during the COVID-19 pandemic has amplified the need to minimise the impacts on mental wellbeing. We investigated the relationship between the perceived changes in the representation of obesity in the media and mental wellbeing during the pandemic in a sample of people with obesity across 10 European countries. We also investigated the potential moderating effect of loneliness. METHODS: Between September to December 2020 during the COVID-19 pandemic, participants reported data on demographics, mental wellbeing (measured by World Health Organisation Five Wellbeing Index and Patient Health Questionaire-4), loneliness (measured by De Jong Gierveld short scale), and perceived change in the representation of obesity in media (measured by a study-specific question) using the online, cross-sectional EURopean Obesity PatiEnt pANdemic Survey (EUROPEANS). Data were analysed using linear mixed-effects models, controlling for age, gender, body mass index, and shielding status, with random incept for country. RESULTS: The survey was completed by 2882 respondents. Most identified as female (56%) and reported their ethnicity as White or White-mix (92%). The total sample had a mean age of 41 years and a BMI of 35.4 kg/m2. During the peak of the pandemic, compared to pre-pandemic, perceiving more negative representation of people with obesity on social media was associated with worse psychological distress, depression, and wellbeing. Perceiving more positive representation, compared to no change in representation, of people with obesity on television was associated with greater wellbeing, yet also higher psychological distress and anxiety. Loneliness, as a moderator, explained ≤0.3% of the variance in outcomes in any of the models. CONCLUSIONS: Perceiving negative representation of obesity on social media was associated with poorer mental wellbeing outcomes during the pandemic; positive representation on television was associated with both positive and negative mental wellbeing outcomes. We encourage greater media accountability when representing people with obesity.

Mechanisms of Action in a Behavioral Weight-Management Program: Latent Growth Curve Analysis.

BACKGROUND: A greater understanding of the mechanisms of action of weight-management interventions is needed to inform the design of effective interventions. PURPOSE: To investigate whether dietary restraint, habit strength, or diet self-regulation mediated the impact of a behavioral weight-management intervention on weight loss and weight loss maintenance. METHODS: Latent growth curve analysis (LGCA) was conducted on trial data in which adults (N = 1,267) with a body mass index (BMI) ≥28 kg/m2 were randomized to either a brief intervention (booklet on losing weight), a 12 week weight-management program or the same program for 52 weeks. LGCA estimated the trajectory of the variables over four time points (baseline and 3, 12 and 24 months) to assess whether potential mechanisms of action mediated the impact of the weight-management program on BMI. RESULTS: Participants randomized to the 12 and 52 week programs had a significantly greater decrease in BMI than the brief intervention. This direct effect became nonsignificant when dietary restraint, habit strength, and autonomous diet self-regulation were controlled for. The total indirect effect was significant for both the 12 (estimate = -1.33, standard error [SE] = 0.41, p = .001) and 52 week (estimate = -2.13, SE = 0.52, p < .001) program. Only the individual indirect effect for dietary restraint was significant for the 12 week intervention, whereas all three indirect effects were significant for the 52 week intervention. CONCLUSIONS: Behavior change techniques that target dietary restraint, habit strength, and autonomous diet self-regulation should be considered when designing weight loss and weight loss maintenance interventions. Longer interventions may need to target both deliberative and automatic control processes to support successful weight management.

Using health economic modelling to inform the design and development of an intervention: estimating the justifiable cost of weight loss maintenance in the UK.

BACKGROUND: There is a need to develop cost-effective weight loss maintenance interventions to prolong the positive impact of weight loss on health outcomes. Conducting pre-trial health economic modelling is recommended to inform the design and development of behavioural interventions. We aimed to use health economic modelling to estimate the maximum cost per-person (justifiable cost) of a cost-effective behavioural weight loss maintenance intervention, given an estimated intervention effect for individuals with: i) a Body Mass Index (BMI) of 28 kg/m2 or above without diabetes and ii) a diagnosis of type 2 diabetes prescribed a single non-insulin diabetes medication. METHODS: The School for Public Health Research Diabetes prevention model was used to estimate the lifetime Quality-adjusted life year (QALY) gains, healthcare costs, and maximum justifiable cost associated with a weight loss maintenance intervention. Based on a meta-analysis, the estimated effect of a weight loss maintenance intervention following a 9 kg weight loss, was a regain of 1.33 kg and 4.38 kg in years one and two respectively compared to greater regain of 2.84 kg and 5.6 kg in the control group. Sensitivity analysis was conducted around the rate of regain, duration of effect and initial weight loss. RESULTS: The justifiable cost for a weight loss maintenance intervention at an ICER of £20,000 per QALY was £104.64 for an individual with a BMI of 28 or over and £88.14 for an individual with type 2 diabetes. Within sensitivity analysis, this varied from £36.42 to £203.77 for the former, and between £29.98 and £173.05 for the latter. CONCLUSIONS: Researchers developing a weight loss maintenance intervention should consider these maximum justifiable cost estimates and the potential impact of the duration of effect and initial weight loss when designing intervention content and deciding target populations. Future research should consider using the methods demonstrated in this study to use health economic modelling to inform the design and budgetary decisions in the development of a behavioural interventions.

Modification of cardiovascular disease risk by health behaviour change following type 2 diabetes diagnosis.

AIMS: Among adults with type 2 diabetes (T2D), unhealthy behaviours are associated with increased risk of cardiovascular disease (CVD) events. To date, little research has considered whether healthy changes in behaviours following T2D diagnosis reduce CVD risk. METHODS: A cohort of 867 adults with screen-detected T2D, participating in the Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care (ADDITION)-Cambridge trial, were followed for 10 years for incidence of CVD events. Diet, alcohol consumption, moderate/vigorous physical activity and smoking were assessed by questionnaire at the time of T2D screening and 1 year later. We estimated associations between health behaviours and CVD using Cox regression. We assessed modification of the associations by behaviour change in the year following T2D diagnosis. RESULTS: Smoking [hazard ratio (HR): 1.73 (95% CI: 1.04, 2.87)] and high fat intake [HR: 1.70 (95% CI: 1.02, 2.85)] were associated with a higher hazard of CVD, while high plasma vitamin C [HR: 0.44 (95% CI: 0.22, 0.87)] and high fibre intake [HR: 0.60 (95% CI: 0.36, 0.99)] were associated with a lower hazard of CVD. Reduction in fat intake following T2D diagnosis modified associations with CVD. In particular, among those with the highest fat intake, decreasing intake attenuated the association with CVD [HR: 0.75 (95% CI: 0.36, 1.56)]. CONCLUSION: Following T2D diagnosis, decreasing fat intake was associated with lower long-term CVD risk. This evidence may raise concerns about low-carbohydrate, high-fat diets to achieve weight loss following T2D diagnosis. Further research considering the sources of fat is needed to inform dietary recommendations. TRIAL REGISTRATION: This trial is registered as ISRCTN86769081. Retrospectively registered on 15 December 2006.

The impact of participant mental health on attendance and engagement in a trial of behavioural weight management programmes: secondary analysis of the WRAP randomised controlled trial.

BACKGROUND: Low attendance and engagement in behavioural weight management trials are common. Mental health may play an important role, however previous research exploring this association is limited with inconsistent findings. We aimed to investigate whether mental health was associated with attendance and engagement in a trial of behavioural weight management programmes. METHODS: This is a secondary data analysis of the Weight loss referrals for adults in primary care (WRAP) trial, which randomised 1267 adults with overweight or obesity to brief intervention, WW (formerly Weight Watchers) for 12-weeks, or WW for 52-weeks. We used regression analyses to assess the association of baseline mental health (depression and anxiety (by Hospital Anxiety and Depression Scale), quality of life (by EQ5D), satisfaction with life (by Satisfaction with Life Questionnaire)) with programme attendance and engagement in WW groups, and trial attendance in all randomised groups. RESULTS: Every one unit of baseline depression score was associated with a 1% relative reduction in rate of WW session attendance in the first 12 weeks (Incidence rate ratio [IRR] 0.99; 95% CI 0.98, 0.999). Higher baseline anxiety was associated with 4% lower odds to report high engagement with WW digital tools (Odds ratio [OR] 0.96; 95% CI 0.94, 0.99). Every one unit of global quality of life was associated with 69% lower odds of reporting high engagement with the WW mobile app (OR 0.31; 95% CI 0.15, 0.64). Greater symptoms of depression and anxiety and lower satisfaction with life at baseline were consistently associated with lower odds of attending study visits at 3-, 12-, 24-, and 60-months. CONCLUSIONS: Participants were less likely to attend programme sessions, engage with resources, and attend study assessments when reporting poorer baseline mental health. Differences in attendance and engagement were small, however changes may still have a meaningful effect on programme effectiveness and trial completion. Future research should investigate strategies to maximise attendance and engagement in those reporting poorer mental health. TRIAL REGISTRATION: The original trial ( ISRCTN82857232 ) and five year follow up ( ISRCTN64986150 ) were prospectively registered with Current Controlled Trials on 15/10/2012 and 01/02/2018.

Positive maternal attitudes to following healthy infant feeding guidelines attenuate the associations between infant appetitive traits and both infant milk intake and weight.

Appetitive traits influence food intake and weight gain throughout the life-course. Here, we investigated whether maternal attitudes to following healthy infant feeding guidelines could modify this association. Baseline data from 544 mother-infant formula-feeding dyads recruited to the Baby Milk Trial were included in this observational, cross-sectional analysis. Infant appetitive traits (food responsiveness and satiety responsiveness), maternal attitudes to following healthy infant feeding guidelines (self-efficacy, outcome-expectancy, intentions) and infant milk intakes were reported by mothers through questionnaires. Infant weight was measured using standard procedures. Associations between the maternal attitudes score or infant appetitive traits with infant milk intake and infant weight were evaluated in linear regression models adjusted for infant sex and age. To identify effect modification, the interaction term between the maternal attitudes score and infant appetitive trait was added to the model. Infants' mean age and weight were 2.3 months (SD = 0.9) and 5.5 kg (SD = 0.9), respectively. The mean daily infant milk intake reported by mothers was 895 ml/day (SD = 215). Higher maternal attitudes score was associated with lower infant milk intake (Beta = -68.4 ml/day/unit (95% CI: 96.6, -40.2)) and infant weight (Beta = -0.13 SD/unit (-0.25, -0.02)). The maternal attitudes score showed interactions with infant food responsiveness on infant milk intake (p = 0.049), and with infant satiety responsiveness on infant weight (p = 0.01). In both cases, a higher maternal attitudes score attenuated the associations between infant appetitive traits and those outcomes. This analysis provides evidence that positive maternal attitudes to following healthy infant feeding guidelines attenuate the effects of infant appetitive traits on infant milk intake and body weight.

The effect of referral to an open-group behavioural weight-management programme on the relative risk of normoglycaemia, non-diabetic hyperglycaemia and type 2 diabetes: Secondary analysis of the WRAP trial.

AIM: To examine the impact of open-group behavioural weight-management programmes on the risk of diabetes among those with a body mass index (BMI) of ≥28 kg/m2 and those with non-diabetic hyperglycaemia (NDH). METHODS: This was a secondary analysis of data from the WRAP trial, in which participants (N = 1267; aged ≥18 years, BMI ≥ 28 kg/m2 ) were randomized to brief intervention (BI; self-help booklet), a weight-management programme (WW; formerly Weight Watchers) for 12 weeks, or WW for 52 weeks. We used multinomial logistic regression to examine the effect of intervention group on the risk of hyperglycaemia and diabetes at 12 months in all participants with glycaemic status at both time points (N = 480; 38%) and those with NDH at baseline (N = 387; 31%). We used mixed effects models and linear fixed effects models to examine the effect of intervention group on body weight and HbA1c at 12 months in people with NDH. RESULTS: There was a 61% relative reduction in the risk of NDH at the 12-month follow-up (12 weeks vs. BI: relative risk ratio [RRR] = 0.39 [95% CI 0.18, 0.87], P = .021; 52 weeks vs. BI: RRR = 0.38 [95% CI 0.17, 0.86], P = .020). For intervention effects on the risk of diabetes, confidence intervals were wide and overlapped 1 [12 weeks vs. BI: RRR = 0.49 [95% CI 0.12, 1.96], P = .312; 52 weeks vs. BI: RRR = 0.40 [95% CI 0.10, 1.63], P = .199). Participants with hyperglycaemia at baseline in the weight-management programme were more probable to have normoglycaemia at the 12-month follow-up [12-week programme vs. BI: RRR = 3.57 [95% CI 1.24, 10.29], P = .019; 52-week programme vs. BI: RRR = 4.14 [95% CI 1.42, 12.12], P = .009). CONCLUSIONS: Open-group behavioural weight-management programmes can help to prevent the development of NDH in people with overweight and obesity and to normalize glycaemia in people with NDH.

Moderate weight change following diabetes diagnosis and 10 year incidence of cardiovascular disease and mortality.

AIMS/HYPOTHESIS: Adults with type 2 diabetes are at high risk of developing cardiovascular disease (CVD). Evidence of the impact of weight loss on incidence of CVD events among adults with diabetes is sparse and conflicting. We assessed weight change in the year following diabetes diagnosis and estimated associations with 10 year incidence of CVD events and all-cause mortality. METHODS: In a cohort analysis among 725 adults with screen-detected diabetes enrolled in the Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care (ADDITION)-Cambridge trial, we estimated HRs for weight change in the year following diabetes diagnosis and 10 year incidence of CVD (n = 99) and all-cause mortality (n = 95) using Cox proportional hazards regression. We used linear regression to estimate associations between weight loss and CVD risk factors. Models were adjusted for age, sex, baseline BMI, smoking, occupational socioeconomic status, cardio-protective medication use and treatment group. RESULTS: Loss of ≥5% body weight in the year following diabetes diagnosis was associated with improvements in HbA1c and blood lipids and a lower hazard of CVD at 10 years compared with maintaining weight (HR 0.52 [95% CI 0.32, 0.86]). The associations between weight gain vs weight maintenance and CVD (HR 0.41 [95% CI 0.15, 1.11]) and mortality (HR 1.63 [95% CI 0.83, 3.19]) were less clear. CONCLUSIONS/INTERPRETATION: Among adults with screen-detected diabetes, loss of ≥5% body weight during the year after diagnosis was associated with a lower hazard of CVD events compared with maintaining weight. These results support the hypothesis that moderate weight loss may yield substantial long-term CVD reduction, and may be an achievable target outside of specialist-led behavioural treatment programmes.

Changes in behaviors after diagnosis of type 2 diabetes and 10-year incidence of cardiovascular disease and mortality.

BACKGROUND: Large changes in health behaviors achieved through intensive lifestyle intervention programs improve cardiovascular disease (CVD) risk factors among adults with type 2 diabetes. However, such interventions are not widely available, and there is limited evidence as to whether changes in behaviors affect risk of CVD events. METHODS: Among 852 adults with screen-detected type 2 diabetes in the ADDITION-Cambridge study, we assessed changes in diet, physical activity, and alcohol use in the year following diabetes diagnosis. Participants were recruited from 49 general practices in Eastern England from 2002 to 2006, and were followed through 2014 for incidence of CVD events (n = 116) and all-cause mortality (n = 127). We used Cox proportional hazards regression to estimate hazard ratios (HR) for the associations of changes in behaviors with CVD and all-cause mortality. We estimated associations with CVD risk factors using linear regression. We considered changes in individual behaviors and overall number of healthy changes. Models adjusted for demographic factors, bodyweight, smoking, baseline value of the health behavior, and cardio-protective medication use. RESULTS: Decreasing alcohol intake by ≥ 2 units/week was associated with lower hazard of CVD vs maintenance [HR: 0.56, 95% CI 0.36, 0.87]. Decreasing daily calorie intake by ≥ 300 kcal was associated with lower hazard of all-cause mortality vs maintenance [HR: 0.56, 95% CI 0.34, 0.92]. Achieving ≥ 2 healthy behavior changes was associated with lower hazard of CVD vs no healthy changes [HR: 0.39, 95% CI 0.18, 0.82]. CONCLUSIONS: In the year following diabetes diagnosis, small reductions in alcohol use were associated with lower hazard of CVD and small reductions in calorie intake were associated with lower hazard of all-cause mortality in a population-based sample. Where insufficient resources exist for specialist-led interventions, achievement of moderate behavior change targets is possible outside of treatment programs and may reduce long-term risk of CVD complications. Trial registration This trial is registered as ISRCTN86769081. Retrospectively registered 15 December 2006.

Extended and standard duration weight-loss programme referrals for adults in primary care (WRAP): a randomised controlled trial.

BACKGROUND: Evidence exist that primary care referral to an open-group behavioural programme is an effective strategy for management of obesity, but little evidence on optimal intervention duration is available. We aimed to establish whether 52-week referral to an open-group weight-management programme would achieve greater weight loss and improvements in a range of health outcomes and be more cost-effective than the current practice of 12-week referrals. METHODS: In this non-blinded, parallel-group, randomised controlled trial, we recruited participants who were aged 18 years or older and had body-mass index (BMI) of 28 kg/m2 or higher from 23 primary care practices in England. Participants were randomly assigned (2:5:5) to brief advice and self-help materials, a weight-management programme (Weight Watchers) for 12 weeks, or the same weight-management programme for 52 weeks. We followed-up participants over 2 years. The primary outcome was weight at 1 year of follow-up, analysed with mixed-effects models according to intention-to-treat principles and adjusted for centre and baseline weight. In a hierarchical closed-testing procedure, we compared combined behavioural programme arms with brief intervention, then compared the 12-week programme and 52-week programme. We did a within-trial cost-effectiveness analysis using person-level data and modelled outcomes over a 25-year time horizon using microsimulation. This study is registered with Current Controlled Trials, number ISRCTN82857232. FINDINGS: Between Oct 18, 2012, and Feb 10, 2014, we enrolled 1269 participants. 1267 eligible participants were randomly assigned to the brief intervention (n=211), the 12-week programme (n=528), and the 52-week programme (n=528). Two participants in the 12-week programme had been found to be ineligible shortly after randomisation and were excluded from the analysis. 823 (65%) of 1267 participants completed an assessment at 1 year and 856 (68%) participants at 2 years. All eligible participants were included in the analyses. At 1 year, mean weight changes in the groups were -3·26 kg (brief intervention), -4·75 kg (12-week programme), and -6·76 kg (52-week programme). Participants in the behavioural programme lost more weight than those in the brief intervention (adjusted difference -2·71 kg, 95% CI -3·86 to -1·55; p<0·0001). The 52-week programme was more effective than the 12-week programme (-2·14 kg, -3·05 to -1·22; p<0·0001). Differences between groups were still significant at 2 years. No adverse events related to the intervention were reported. Over 2 years, the incremental cost-effectiveness ratio (ICER; compared with brief intervention) was £159 per kg lost for the 52-week programme and £91 per kg for the 12-week programme. Modelled over 25 years after baseline, the ICER for the 12-week programme was dominant compared with the brief intervention. The ICER for the 52-week programme was cost-effective compared with the brief intervention (£2394 per quality-adjusted life-year [QALY]) and the 12-week programme (£3804 per QALY). INTERPRETATION: For adults with overweight or obesity, referral to this open-group behavioural weight-loss programme for at least 12 weeks is more effective than brief advice and self-help materials. A 52-week programme produces greater weight loss and other clinical benefits than a 12-week programme and, although it costs more, modelling suggests that the 52-week programme is cost-effective in the longer term. FUNDING: National Prevention Research Initiative, Weight Watchers International (as part of an UK Medical Research Council Industrial Collaboration Award).

Greater improvements in diet quality among overweight participants following a group-based commercial weight loss programme than those receiving support to lose weight in primary care.

BACKGROUND: Relatively little is known about dietary changes and their relationships with weight change during behavioural weight loss interventions. In a secondary analysis of data from a multicentre RCT, we investigated whether greater improvements in diet would be achieved by overweight adults following a 12 month group-based commercial weight loss programme (CP) than those receiving standard care (SC) in primary practice, and if these dietary changes were associated with greater weight loss. METHODS: Adults with a BMI 27-35 kg/m2 and >1 risk factor for obesity-related disorders were recruited in study centres in Australia and the UK during 2007-2008. Dietary intake and body weight were measured at baseline, 6 and 12 months. Linear mixed effects models compared mean changes in dietary macronutrient intake, fibre density and energy density over time between groups, and their relationships with weight loss. RESULTS: The CP group demonstrated greater mean weight loss than the SC group at 6 months (3.3 kg, 95% CI: 2.2, 4.4) and 12 months (3.3 kg, 95% CI: 2.1, 4.5). Diet quality improved in both intervention groups at 6 and 12 months. However, the CP group (n = 228) achieved significantly greater mean reductions in energy intake (mean difference; 95% CI: - 503 kJ/d; - 913, - 93), dietary energy density (- 0.48 MJ/g; - 0.81, - 0.16), total fat (- 6.9 g/d; - 11.9, - 1.8), saturated fat (- 3.3 g/d; - 5.4, - 1.1), and significantly greater mean increases in fibre density (0.30 g/MJ; 0.15, 0.44) at 6 months than the SC group (n = 239). Similar differences persisted at 12 months and the CP group showed greater mean increases in protein density (0.65 g/MJ). In both groups, weight loss was associated with increased fibre density (0.68 kg per g/MJ, 95% CI: 0.08, 1.27) and protein density (0.26 kg per g/MJ, 95% CI: 0.10, 0.41). CONCLUSIONS: Following a group-based commercial program led to greater improvements in diet quality than standard care. Increases in dietary protein and fibre density were independently associated with weight loss in both behavioural weight loss interventions. Greater increases in protein and fibre density in the commercial program likely contributed to their greater weight loss. TRIAL REGISTRATION: ISRCTN: ISRCTN85485463 Registered 03/08/2007 Retrospectively Registered.

Impact of weight maintenance and loss on diabetes risk and burden: a population-based study in 33,184 participants.

BACKGROUND: Weight loss in individuals at high risk of diabetes is an effective prevention method and a major component of the currently prevailing diabetes prevention strategies. The aim of the present study was to investigate the public health potential for diabetes prevention of weight maintenance or moderate weight loss on a population level in an observational cohort with repeated measurements of weight and diabetes status. METHODS: Height, weight and diabetes status were objectively measured at baseline and 10 year follow-up in a population-based cohort of 33,184 participants aged 30-60 years between 1990 and 2013 in Västerbotten County, Sweden. The association between risk of incident diabetes and change in BMI or relative weight was modelled using multivariate logistic regression. Population attributable fractions (PAF) were used to assess population impact of shift in weight. RESULTS: Mean (SD) BMI at baseline was 25.0 (3.6) kg/m2. Increase in relative weight between baseline and follow-up was linearly associated with incident diabetes risk, odds ratio (OR) 1.05 (95% confidence interval (CI) 1.04-1.06) per 1% change in weight. Compared to weight maintenance (±1.0 kg/m2), weight gain of > +1.0 kg/m2 was associated with an increased risk of incident diabetes, OR 1.52 (95% CI 1.32, 1.74), representing a PAF of 21.9% (95% CI 15.8, 27.6%). For moderate weight loss (-1.0 to -2.0 kg/m2) the OR was 0.72 (95% CI 0.52, 0.99). CONCLUSIONS: Weight maintenance in adulthood is strongly associated with reduced incident diabetes risk and there is considerable potential for diabetes prevention in promoting this as a whole population strategy.