Nicholas R. Fuller

Primary care referral to a commercial provider for weight loss treatment versus standard care: a randomised controlled trial

Summary Background The increasing prevalence of overweight and obesity needs effective approaches for weight loss in primary care and community settings. We compared weight loss with standard treatment in primary care with that achieved after referral by the primary care team to a commercial provider in the community. Methods In this parallel group, non-blinded, randomised controlled trial, 772 overweight and obese adults were recruited by primary care practices in Australia, Germany, and the UK. Participants were randomly assigned with a computer-generated simple randomisation sequence to receive either 12 months of standard care as defined by national treatment guidelines, or 12 months of free membership to a commercial programme (Weight Watchers), and followed up for 12 months. The primary outcome was weight change over 12 months. Analysis was by intention to treat (last observation carried forward [LOCF] and baseline observation carried forward [BOCF]) and in the population who completed the 12-month assessment. This trial is registered, number ISRCTN85485463. Findings 377 participants were assigned to the commercial programme, of whom 230 (61%) completed the 12-month assessment; and 395 were assigned to standard care, of whom 214 (54%) completed the 12-month assessment. In all analyses, participants in the commercial programme group lost twice as much weight as did those in the standard care group. Mean weight change at 12 months was −5·06 kg (SE 0·31) for those in the commercial programme versus −2·25 kg (0·21) for those receiving standard care (adjusted difference −2·77 kg, 95% CI −3·50 to −2·03) with LOCF; −4·06 kg (0·31) versus −1·77 kg (0·19; adjusted difference −2·29 kg, −2·99 to −1·58) with BOCF; and −6·65 kg (0·43) versus −3·26 kg (0·33; adjusted difference −3·16 kg, −4·23 to −2·11) for those who completed the 12-month assessment. Participants reported no adverse events related to trial participation. Interpretation Referral by a primary health-care professional to a commercial weight loss programme that provides regular weighing, advice about diet and physical activity, motivation, and group support can offer a clinically useful early intervention for weight management in overweight and obese people that can be delivered at large scale. Funding Weight Watchers International, through a grant to the UK Medical Research Council.

An intragastric balloon in the treatment of obese individuals with metabolic syndrome: a randomized controlled study.

There are limited controlled data for intragastric balloons (IGB) in obesity treatment. This randomized, controlled study evaluated the efficacy and safety of an IGB in obese individuals with metabolic syndrome (MS).

The effect of a high-egg diet on cardiovascular risk factors in people with type 2 diabetes: the Diabetes and Egg (DIABEGG) study—a 3-mo randomized controlled trial

BACKGROUND Previously published research that examined the effects of high egg consumption in people with type 2 diabetes (T2D) produced conflicting results leading to recommendations to limit egg intake. However, people with T2D may benefit from egg consumption because eggs are a nutritious and convenient way of improving protein and micronutrient contents of the diet, which have importance for satiety and weight management. OBJECTIVE In this randomized controlled study, we aimed to determine whether a high-egg diet (2 eggs/d for 6 d/wk) compared with a low-egg diet (<2 eggs/wk) affected circulating lipid profiles, in particular high-density lipoprotein (HDL) cholesterol, in overweight or obese people with prediabetes or T2D. DESIGN A total of 140 participants were randomly assigned to one of the 2 diets as part of a 3-mo weight maintenance study. Participants attended the clinic monthly and were instructed on the specific types of foods and quantities to be consumed. RESULTS There was no significant difference in the change in HDL cholesterol from screening to 3 mo between groups; the mean difference (95% CI) between high- and low-egg groups was +0.02 mmol/L (-0.03, 0.08 mmol/L; P = 0.38). No between-group differences were shown for total cholesterol, low-density lipoprotein cholesterol, triglycerides, or glycemic control. Both groups were matched for protein intake, but the high-egg group reported less hunger and greater satiety postbreakfast. Polyunsaturated fatty acid (PUFA) and monounsaturated fatty acid (MUFA) intakes significantly increased from baseline in both groups. CONCLUSIONS High egg consumption did not have an adverse effect on the lipid profile of people with T2D in the context of increased MUFA and PUFA consumption. This study suggests that a high-egg diet can be included safely as part of the dietary management of T2D, and it may provide greater satiety. This trial was registered at the Australia New Zealand Clinical Trials Registry (http://www.anzctr.org.au/) as ACTRN12612001266853.

The Influence of Mediterranean, Carbohydrate and High Protein Diets on Gut Microbiota Composition in the Treatment of Obesity and Associated Inflammatory State

The role of the gut microbiota in understanding the onset and development of obesity is gaining importance. Dietary strategies are the main tool employed to counteract obesity, and nowadays they are focused on a wide range of different aspects of diet and not only on calorie restriction. Additionally, diet is known to be a major factor influencing modification of the gut microbiota. Therefore the influence of both macronutrient and micronutrient content of any dietary strategy to treat obesity on gut bacterial composition should now be taken into consideration, in addition to energy restriction. This review aims to collect the available data regarding the influence of different dietary components on gut microbiota in relation to obesity and inflammatory states in humans. Although more work is needed, specific dietary factors (carbohydrate, protein and Mediterranean foods) have been shown to have an influence on the gut microbiome composition, meaning that there is an opportunity to prevent and treat obesity based on microbiota outcomes.

A within-trial cost-effectiveness analysis of primary care referral to a commercial provider for weight loss treatment, relative to standard care—an international randomised controlled trial

Background:Due to the high prevalence of overweight and obesity there is a need to identify cost-effective approaches for weight loss in primary care and community settings.Objective:We evaluated the cost effectiveness of two weight loss programmes of 1-year duration, either standard care (SC) as defined by national guidelines, or a commercial provider (Weight Watchers) (CP).Design:This analysis was based on a randomised controlled trial of 772 adults (87% female; age 47.4±12.9 years; body mass index 31.4±2.6 kg m−2) recruited by health professionals in primary care in Australia, United Kingdom and Germany. Both a health sector and societal perspective were adopted to calculate the cost per kilogram of weight loss and the ICER, expressed as the cost per quality adjusted life year (QALY).Results:The cost per kilogram of weight loss was USD122, 90 and 180 for the CP in Australia, the United Kingdom and Germany, respectively. For SC the cost was USD138, 151 and 133, respectively. From a health-sector perspective, the ICER for the CP relative to SC was USD18 266, 12 100 and 40 933 for Australia, the United Kingdom and Germany, respectively. Corresponding societal ICER figures were USD31 663, 24 996 and 51 571.Conclusion:The CP was a cost-effective approach from a health funder and societal perspective. Despite participants in the CP group attending two to three times more meetings than the SC group, the CP was still cost effective even including these added patient travel costs. This study indicates that it is cost effective for general practitioners (GPs) to refer overweight and obese patients to a CP, which may be better value than expending public funds on GP visits to manage this problem.

The challenge of a 2-year follow-up after intervention for weight loss in primary care

Background:Many weight loss programmes show short-term success, but long-term data in larger studies are scarce, especially in community settings. Attrition is common and complicates the interpretation of long-term outcomes.Objective:To investigate 2-year outcomes and explore issues of attrition and missing data.Subjects:A total of 772 overweight and obese adults recruited by primary care practices in Australia, Germany and the UK and randomised to a 12-month weight loss intervention delivered in a commercial programme (CP) or in standard care (SC).Measurement:Weight change from 0–24 and 12–24 months including measured weights only and measured and self-reported weights, using last observation carried forward (LOCF), baseline observation carried forward (BOCF), completers-only and missing-at-random (MAR) analyses.Results:A total of 203 participants completed the 24-month visit. Using measured weights only, there was a trend for greater 24-month weight loss in CP than in SC, but the difference was only statistically significant in the LOCF and BOCF analyses: LOCF: −4.14 vs −1.99 kg, difference adjusted for centre −2.08 kg, P<0.001; BOCF: −1.33 vs −0.74 kg, adjusted difference −0.60 kg, P=0.032; completers: −4.76 vs −2.99 kg, adjusted difference −1.53 kg, P=0.113; missing at random: −3.00 vs −1.94 kg, adjusted difference −1.04 kg, P=0.150. Both groups gained weight from 12–24 months and weight regain was significantly (P<0.001) greater for CP than for SC in all analysis approaches. Inclusion of self-reported weights from a further 138 participants did not change the interpretation of the findings.Conclusion:Initial weight loss was poorly maintained during the no-intervention follow-up, but both groups did have lower weight over the 24 months. Attrition was high in both groups, and assumptions about missing data had considerable impact on the magnitude and statistical significance of treatment effects. It is vital that trials on weight loss interventions consider the plausibility of these differences in an analytical approach when interpreting research findings and comparing data between studies.

Egg Consumption and Human Cardio-Metabolic Health in People with and without Diabetes

The guidelines for dietary cholesterol and/or egg intake for both the general population and those at higher risk of cardiovascular disease (for example, people with type 2 diabetes mellitus (T2DM)) differ between countries, and even for different specialist societies in a country. The disparity between these guidelines is at least in part related to the conflicting evidence as to the effects of eggs in the general population and in those with T2DM. This review addresses the effect of eggs on cardiovascular disease (CVD) risk from both epidemiological research and controlled prospective studies, in people with and without cardio-metabolic disease. It also examines the nutritional qualities of eggs and whether they may offer protection against chronic disease. The evidence suggests that a diet including more eggs than is recommended (at least in some countries) may be used safely as part of a healthy diet in both the general population and for those at high risk of cardiovascular disease, those with established coronary heart disease, and those with T2DM. In conclusion, an approach focused on a person’s entire dietary intake as opposed to specific foods or nutrients should be the heart of population nutrition guidelines.

Cost effectiveness of primary care referral to a commercial provider for weight loss treatment, relative to standard care: a modelled lifetime analysis.

Background:Because of the high prevalence of overweight and obesity, there is a need to identify cost-effective approaches for weight loss in primary care and community settings.Objective:To evaluate the long-term cost effectiveness of a commercial weight loss programme (Weight Watchers) (CP) compared with standard care (SC), as defined by national guidelines.Methods:A Markov model was developed to calculate the incremental cost-effectiveness ratio (ICER), expressed as the cost per quality-adjusted life year (QALY) over the lifetime. The probabilities and quality-of-life utilities of outcomes were extrapolated from trial data using estimates from the published literature. A health sector perspective was adopted.Results:Over a patient’s lifetime, the CP resulted in an incremental cost saving of AUD 70 per patient, and an incremental 0.03 QALYs gained per patient. As such, the CP was found to be the dominant treatment, being more effective and less costly than SC (95% confidence interval: dominant to 6225 per QALY). Despite the CP delaying the onset of diabetes by ∼10 months, there was no significant difference in the incidence of type 2 diabetes, with the CP achieving <0.1% fewer cases than SC over the lifetime.Conclusion:The modelled results suggest that referral to community-based interventions may provide a highly cost-effective approach for those at high risk of weight-related comorbidities.

A 12-week, randomised, controlled trial to examine the acceptability of the Korean diet and its effectiveness on weight and metabolic parameters in an Australian overweight and obese population

SUMMARY BACKGROUND South Korea has a significantly lower prevalence of overweight and obesity compared to Western countries. This may be due to differences between the traditional Korean diet (KD) and western diet (WD). OBJECTIVE Our study investigated whether a Western population would accept a KD, compared to a WD, in a weight loss oriented lifestyle program. DESIGN 70 overweight or obese participants were randomised to a 12-week weight loss program. All participants followed a standardised lifestyle intervention incorporating diet, exercise and behavioural modification techniques. KD participants were provided with a traditional Korean lunch and dinner (Monday to Saturday). WD participants were provided with a weekly grocery food voucher. Weight and metabolic parameters were measured. RESULTS 60 participants completed the study (KD = 25; WD = 35). No significant difference was found for percentage weight loss (KD: -5.8 ± 4.7%; WD: -5.7 ± 4.1%; p = 0.93). On the 10-item Food Acceptability Questionnaire, there was a decline in acceptance for the KD group over the 12-week intervention. CONCLUSIONS When incorporated into a lifestyle intervention a traditional KD resulted in similar weight loss to a WD, despite a significantly higher energy intake. Food acceptability scores significantly favoured the WD for some of the measures at week 12, and the most common staple Korean foods were reported highest amongst the food returns, suggesting that the KD was not as well accepted and less enjoyable on a range of measures. More variability in the menu and flexibility in portion sizes of the KD may improve its acceptance and could further optimise its weight loss potential for Westerners.

Changes in physical activity during a weight loss intervention and follow-up: a randomized controlled trial

Physical activity is an important component in weight loss treatment and weight maintenance. We evaluated the physical activity component of two weight loss programmes, either standard care (SC) as defined by national guidelines, or a commercial programme (CP; Weight Watchers) over the period of weight loss and follow‐up. 772 adults (mean body mass index: 31.4 ± 2.6 kg m−2) were recruited by primary care practices in Australia, the United Kingdom, and Germany, and randomly assigned to 12 months SC, or the CP. They were then followed up at 24 months. Change in physical activity levels were assessed by the International Physical Activity Questionnaire (IPAQ)‐short form, and pedometer recordings. Both groups reported increases in physical activity using the IPAQ from baseline to 12 months and 24 months (within groups P < 0.0001) and in pedometer steps from baseline to 12 months only (within groups P < 0.0001). Differences between groups with both methods of assessment were not significant. There was a significant difference in weight loss between the groups at 12 months favouring the CP group; however, this statistical difference was not maintained at 24 months. In conclusion, despite similar increases in reported activity, there were significant differences in weight loss and regain between groups. Therefore, greater weight loss seen with the CP is unlikely to be due to increases in physical activity. Trends in pedometer steps mirrored changes in weight over time more closely than the IPAQ; however, both assessment tools have limitations. Better activity assessment measures are needed to more accurately gauge changes in physical activity during weight loss interventions.