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

$\textit{Background}$ 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. $\textit{Methods}$ 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. $\textit{Findings}$ 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). $\textit{Interpretation}$ 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.This trial was funded by the National Prevention Research Initiative grant MR/J000493/1. The cost of the Weight Watchers® programme and the costs of blood sampling and analysis were funded by Weight Watchers International as part of an MRC Industrial Collaboration Award

Regional differences in portion size consumption behaviour: Insights for the global food industry

Abstract: Given the influence of globalization on consumer food behaviour across the world, the purpose of this paper is to contribute to the theoretical discourse around food portion size as a global consumption-related symbol and its underlying socio-economic drivers for food industry strategy. Overall, 25,000 global food consumers were surveyed across 24 countries to elicit insight on portion size consumption behaviour as well as consumer perception on eating and drinking small portion size within selected socio-economic classes. The data was quantitatively analysed to answer the pertinent research objectives. In 20 out of the 24 global markets surveyed, large food portion size was statistically established as a prevalent consumption-related symbol. The paper found that there are regional differences in portion size food consumption behaviour, and further disparities exist across age, gender and income status in 24 countries covering all regions, including Australia, China, Mexico, South Africa, United Kingdom and United States of America. The outlined food industry implications reveal that adaptation and standardisation strategies are still relevant in global food and nutrition strategy as revealed by the variations in the preference for food portion sizes across various countries of the world

Large portion sizes increase bite size and eating rate in overweight women

Objective: Larger food portions lead to increased intake but the mechanism behind this effect is unclear. We investigated the effect of portion size on bite size, eating rate, deceleration rate, and meal duration. Design and methods: Thirty-seven overweight women attended 5 visits after a 3h fast and consumed a 229, 303, 400, 529 or 700g portion of a lunch meal in random order. Meal eating parameters were measured with the Sussex Ingestion Pattern Monitor. Data were analyzed with mixed effects models. Results: Average bite size increased by 0.22g for every 100g increase in portion size (p=0.001); portion size had a non-linear effect on eating rate, increasing with portion sizes up to about 540g (p=0.01). Deceleration rate (reduction in speed of eating) decreased by 20% (p<0.001) and meal duration increased by 22.5% for every 100g increase in portion size (p<0.001), relative to the smallest portion. Conclusions: Increasing portion size led to a larger bite size and faster eating rate, but a slower reduction in eating speed during the meal. These changes may underlie greater energy intakes with exposure to large portions. Interventions to reduce bite size and slow eating rate may provide individuals with strategies to reduce the risk of overconsumption

Primary Care SHOPping intervention for cardiovascular disease prevention (PC-SHOP): protocol for a randomised controlled trial to reduce saturated fat intake.

Introduction A diet high in saturated fat (SFA) increases the risk of cardiovascular disease (CVD) and intakes in the UK exceed dietary recommendations. The Primary Care Shopping Intervention for Cardiovascular Disease Prevention (PC-SHOP) study aims to test the effect of an intervention for people with raised low-density lipoprotein (LDL) cholesterol involving health professional (HP) advice alone, or in combination with personalised feedback based on nutritional analysis of grocery store loyalty card data, on SFA intake and blood lipids in comparison with no intervention. Methods and analysis PC-SHOP is a three-arm parallel randomised controlled trial with an allocation ratio of 1:3:3 (‘no intervention’: n=16, ‘brief support’: n=48, ‘brief support plus shopping feedback’: n=48, respectively). Participants with raised LDL will be recruited from general practitioner (GP) practices for a 3-month intervention period. In brief support, an HP will deliver a behaviourally informed 10 min consultation and provide a written self-help guide to inform and motivate people to reduce their SFA intake. In brief support plus shopping feedback, the participants will receive the same HP-led behavioural support and, based on data from their grocery store loyalty card, personalised feedback on the SFA content of their grocery shopping, identifying high SFA purchases and suggesting swaps to similar but lower SFA items. Measurements for the primary and secondary outcomes will be collected at baseline and at follow-up (3 months). The primary outcome measure will be the between-group difference in the reduction of SFA intake between baseline and follow-up. Secondary outcomes include changes in blood lipids and SFA content of food purchases, with process measures to consider the feasibility and acceptability of the intervention. Ethics and dissemination This study has been reviewed and approved by the National Health Service Health Research Authority Research Ethics Committee (Ref: 17/SC/0168). The trial findings will be disseminated to academic and HPs through presentations at meetings and peer-reviewed journals and to the public through the media. If the intervention is effective, the results will be communicated to relevant stakeholders, including policymakers and retailers. Trial registration number ISRCTN14279335; Pre-results.</p

National Safety Associates nutritional supplementation trial of fruit and vegetable extracts and vascular function (NNTV): study protocol for a randomised controlled trial

Background Cardiovascular disease has a multifactorial aetiology with a number of both modifiable and non-modifiable risk factors. Although evidence indicates that dietary intake plays an important role, few studies have focused on the effect of fruit and vegetable consumption on early markers of vascular function. Therefore, we hypothesised that supplementation with capsules containing a combination of fruit and vegetable extracts over 12 weeks can significantly modulate biomarkers of vascular function compared with a control group receiving placebo. Methods/Design This is a double-blind, randomised controlled trial that includes overweight and obese but otherwise healthy participants. Participants are randomly allocated to one of two groups: active supplementation (encapsulated fruit and vegetable powder) or placebo taken twice daily for 12 weeks, whereas both groups will be given the ‘5-A-Day’ dietary advice. The primary outcome is to measure changes to the carotid intima media thickness (cIMT) between the two groups from baseline (test visit 1) to 12 weeks later (test visit 2). The secondary outcomes include macro- and microvascular changes and changes to blood markers. Discussion In addition to the primary and secondary objectives, this explanatory trial incorporates potential novel biomarkers such as trimethylamine-N-oxide (TMAO) and lipopolysaccharide (LPS)

National Safety Associates nutritional supplementation trial of fruit and vegetable extracts and vascular function (NNTV): study protocol for a randomised controlled trial

Background Cardiovascular disease has a multifactorial aetiology with a number of both modifiable and non-modifiable risk factors. Although evidence indicates that dietary intake plays an important role, few studies have focused on the effect of fruit and vegetable consumption on early markers of vascular function. Therefore, we hypothesised that supplementation with capsules containing a combination of fruit and vegetable extracts over 12 weeks can significantly modulate biomarkers of vascular function compared with a control group receiving placebo. Methods/Design This is a double-blind, randomised controlled trial that includes overweight and obese but otherwise healthy participants. Participants are randomly allocated to one of two groups: active supplementation (encapsulated fruit and vegetable powder) or placebo taken twice daily for 12 weeks, whereas both groups will be given the ‘5-A-Day’ dietary advice. The primary outcome is to measure changes to the carotid intima media thickness (cIMT) between the two groups from baseline (test visit 1) to 12 weeks later (test visit 2). The secondary outcomes include macro- and microvascular changes and changes to blood markers. Discussion In addition to the primary and secondary objectives, this explanatory trial incorporates potential novel biomarkers such as trimethylamine-N-oxide (TMAO) and lipopolysaccharide (LPS)

Impact of High Energy Nutritional Supplement Drinks on Energy Intake, Appetite Measures, Appetite Hormones, and Rate Of Gastric Emptying

No abstract available

Primary Care SHOPping intervention for cardiovascular disease prevention (PC-SHOP): protocol for a randomised controlled trial to reduce saturated fat intake.

Introductionandnbsp;A diet high in saturated fat (SFA) increases the risk of cardiovascular disease (CVD) and intakes in the UK exceed dietary recommendations. The Primary Care Shopping Intervention for Cardiovascular Disease Prevention (PC-SHOP) study aims to test the effect of an intervention for people with raised low-density lipoprotein (LDL) cholesterol involving health professional (HP) advice alone, or in combination with personalised feedback based on nutritional analysis of grocery store loyalty card data, on SFA intake and blood lipids in comparison with no intervention. Methods and analysisandnbsp;PC-SHOP is a three-arm parallel randomised controlled trial with an allocation ratio of 1:3:3 (andlsquo;no interventionandrsquo;: n=16, andlsquo;brief supportandrsquo;: n=48, andlsquo;brief support plus shopping feedbackandrsquo;: n=48,andthinsp;respectively). Participants with raised LDL will be recruited from general practitioner (GP) practices for a 3-month intervention period. In brief support, an HP will deliver a behaviourally informed 10andthinsp;min consultation and provide a written self-help guide to inform and motivate people to reduce their SFA intake. In brief support plus shopping feedback, the participants will receive the same HP-led behavioural support and, based on data from their grocery store loyalty card, personalised feedback on the SFA content of their grocery shopping, identifying high SFA purchases and suggesting swaps to similar but lower SFA items. Measurements for the primary and secondary outcomes will be collected at baseline and at follow-up (3 months). The primary outcome measure will be the between-group difference in the reduction of SFA intake between baseline and follow-up. Secondary outcomes include changes in blood lipids and SFA content of food purchases, with process measures to consider the feasibility and acceptability of the intervention. Ethics and disseminationandnbsp;This study has been reviewed and approved by the National Health Service Health Research Authority Research Ethics Committee (Ref: 17/SC/0168). The trial findings will be disseminated to academic and HPs through presentations at meetings and peer-reviewed journals and to the public through the media. If the intervention is effective, the results will be communicated to relevant stakeholders, including policymakers and retailers. Trial registration numberandnbsp;ISRCTN14279335; Pre-results.</p

PP197-MON IMPACT OF HIGH ENERGY NUTRITIONAL SUPPLEMENT DRINKS ON ENERGY INTAKE, APPETITE MEASURES, APPETITE HORMONES, AND RATE OF GASTRIC EMPTYING

No abstract available

Large portion sizes increase bite size and eating rate in overweight women

Objective Larger food portions lead to increased intake but the mechanism behind this effect is unclear. We investigated the effect of portion size on bite size, eating rate, deceleration rate, and meal duration. Design and methods Thirty-seven overweight women attended 5 visits after a 3 h fast and consumed a 229, 303, 400, 529 or 700 g portion of a lunch meal in random order. Meal eating parameters were measured with the Sussex Ingestion Pattern Monitor. Data were analyzed with mixed effects models. Results Average bite size increased by 0.22 g for every 100 g increase in portion size (p = 0.001); portion size had a non-linear effect on eating rate, increasing with portion sizes up to about 540 g (p = 0.01). Deceleration rate (reduction in speed of eating) decreased by 20% (p &lt; 0.001) and meal duration increased by 22.5% for every 100 g increase in portion size (p &lt; 0.001), relative to the smallest portion. Conclusions Increasing portion size led to a larger bite size and faster eating rate, but a slower reduction in eating speed during the meal. These changes may underlie greater energy intakes with exposure to large portions. Interventions to reduce bite size and slow eating rate may provide individuals with strategies to reduce the risk of overconsumption