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Eating Disorders In weight-related Therapy (EDIT) Collaboration: rationale and study design.
Lister, NB, Baur, LA, Paxton, SJ, Garnett, SP, Ahern, AL, Wilfley, DE, Maguire, S, Sainsbury, A, Steinbeck, K, Braet, C, et al
Nutrition research reviews. 2023;:1-11
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Abstract
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.
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Is binge eating associated with poor weight loss outcomes in people with a high body weight? A systematic review with meta-analyses.
Lobo, I, da Luz, FQ, Hay, P, Gaeta, TL, Teixeira, PC, Cordás, TA, Sainsbury, A, Salis, Z
Eating and weight disorders : EWD. 2023;(1):89
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Abstract
OBJECTIVES This systematic review aimed to compare the weight change in people with or without binge eating who underwent various weight loss treatments. METHODS We searched for studies in PubMed, American Psychological Association, and Embase from inception to January 2022. The studies selected included assessment of binge eating and body weight before and after weight loss treatment in people of any age. The meta-analyses were conducted using Comprehensive Meta-Analysis (CMA). We used Egger's regression test, the funnel plot, and the Trim and Fill test to assess the risk of publication bias. RESULTS Thirty-four studies were included in the systematic review, with a total of 10.184 participants. The included studies were divided into three categories according to types of weight loss treatments, namely, (1) bariatric surgery; (2) pharmacotherapy isolated or combined with behavioral interventions; and (3) behavioral and/or nutritional interventions. The meta-analyses showed no significant difference in weight loss between people with or without binge eating engaged in weight loss treatments, with an overall effect size of - 0.117 (95% CI - 0.405 to 0.171; P = 0.426). CONCLUSIONS Our findings showed no difference in weight loss in people with or without pre-treatment binge eating who received various weight loss treatments. Weight loss treatments should not be withheld on the basis that they will not be effective in people with pre-treatment binge eating, albeit their safety and longer term impacts are unclear. LEVEL OF EVIDENCE Level I, at least one properly designed randomized controlled trials; systematic reviews and meta-analyses; experimental studies.
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Eating disorders in weight-related therapy (EDIT): Protocol for a systematic review with individual participant data meta-analysis of eating disorder risk in behavioural weight management.
Jebeile, H, Lister, NB, Libesman, S, Hunter, KE, McMaster, CM, Johnson, BJ, Baur, LA, Paxton, SJ, Garnett, SP, Ahern, AL, et al
PloS one. 2023;(7):e0282401
Abstract
The Eating Disorders In weight-related Therapy (EDIT) Collaboration brings together data from randomised controlled trials of behavioural weight management interventions to identify individual participant risk factors and intervention strategies that contribute to eating disorder risk. We present a protocol for a systematic review and individual participant data (IPD) meta-analysis which aims to identify participants at risk of developing eating disorders, or related symptoms, during or after weight management interventions conducted in adolescents or adults with overweight or obesity. We systematically searched four databases up to March 2022 and clinical trials registries to May 2022 to identify randomised controlled trials of weight management interventions conducted in adolescents or adults with overweight or obesity that measured eating disorder risk at pre- and post-intervention or follow-up. Authors from eligible trials have been invited to share their deidentified IPD. Two IPD meta-analyses will be conducted. The first IPD meta-analysis aims to examine participant level factors associated with a change in eating disorder scores during and following a weight management intervention. To do this we will examine baseline variables that predict change in eating disorder risk within intervention arms. The second IPD meta-analysis aims to assess whether there are participant level factors that predict whether participation in an intervention is more or less likely than no intervention to lead to a change in eating disorder risk. To do this, we will examine if there are differences in predictors of eating disorder risk between intervention and no-treatment control arms. The primary outcome will be a standardised mean difference in global eating disorder score from baseline to immediately post-intervention and at 6- and 12- months follow-up. Identifying participant level risk factors predicting eating disorder risk will inform screening and monitoring protocols to allow early identification and intervention for those at risk.
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Effect of severe compared with moderate energy restriction on physical activity among postmenopausal female adults with obesity: a prespecified secondary analysis of the Type of Energy Manipulation for Promoting optimum metabolic health and body composition in Obesity (TEMPO) Diet randomized controlled Trial.
Jin, X, Gibson, AA, Salis, Z, Seimon, RV, Harper, C, Markovic, TP, Byrne, NM, Keating, SE, Stamatakis, E, Inan-Eroglu, E, et al
The American journal of clinical nutrition. 2022;(5):1393-1403
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Abstract
BACKGROUND An under-explored strategy for increasing physical activity is the dietary treatment of obesity, but empirical evidence is lacking. OBJECTIVES We aimed to compare the effects of weight loss via severe as opposed to moderate energy restriction on physical activity over 36 mo. METHODS A total of 101 postmenopausal female adults (45-65 y, BMI 30-40 kg/m2, <180 min/wk of structured exercise) were randomly assigned to either 12 mo of moderate energy restriction (25%-35% of energy requirement) with a food-based diet, or a severe intervention involving 4 mo of severe energy restriction (65%-75% of energy requirement) with a total meal replacement diet, followed by 8 mo of moderate energy restriction. Physical activity was encouraged, but no tailored or supervised exercise prescription was provided. Physical activity was assessed with an accelerometer worn for 7 d before baseline (0 mo) and 0.25, 1, 4, 6, 12, 24, and 36 mo after intervention commencement. RESULTS Compared with the moderate group, the severe group exhibited greater mean: total volume of physical activity; duration of moderate-to-vigorous-intensity physical activity (MVPA); duration of light-intensity physical activity; step counts, as well as lower mean duration of sedentary time. All these differences (except step counts) were apparent at 6 mo [e.g., 1006 metabolic equivalent of task (MET)-min/wk; 95% CI: 564, 1449 MET-min/wk for total volume of physical activity], and some were also apparent at 4 and/or 12 mo. There were no differences between groups in the 2 other outcomes investigated (self-efficacy to regulate exercise; and proportion of participants meeting the WHO's 2020 Physical Activity Guidelines for MVPA). When the analyses were adjusted for weight at each time point, the differences between groups were either attenuated or abolished. CONCLUSIONS Among female adults with obesity, including a dietary component to reduce excess body weight-notably one involving severe energy restriction-could potentially enhance the effectiveness of physical activity interventions.This trial was registered at www.anzctr.org.au as ACTRN12612000651886.
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Physical and mental health outcomes of an integrated cognitive behavioural and weight management therapy for people with an eating disorder characterized by binge eating and a high body mass index: a randomized controlled trial.
Hay, P, Palavras, MA, da Luz, FQ, Dos Anjos Garnes, S, Sainsbury, A, Touyz, S, Appolinario, JC, Claudino, AM
BMC psychiatry. 2022;(1):355
Abstract
BACKGROUND Bulimia nervosa (BN) and binge eating disorder (BED) are eating disorders (EDs) characterized by recurrent binge eating. They are associated with medical complications, impaired adaptive function and often a high BMI, for which a multidisciplinary treatment approach may be needed. This study explored the efficacy of a novel intervention integrating Cognitive Behavioural Therapy- Enhanced (CBT-E) and weight management for people with recurrent binge eating episodes and high BMI with respect to physical, psychopathological and quality of life outcomes. METHODS Ninety-eight adults diagnosed with BN, BED, or Other Specified/Unspecified Feeding or Eating Disorder (OSFED/UFED) and BMI ≥ 27 to <40 kg/m2 were randomized to a multidisciplinary approach, the Healthy APproach to weIght management and Food in Eating Disorders (HAPIFED) or to CBT-E. Metabolic parameters, health-related quality of life, general psychological and ED symptoms and ED diagnostic status outcomes are reported. Data were analyzed with mixed effects models adopting multiple imputed datasets where data were missing. RESULTS Both HAPIFED and CBT-E showed statistical significance for the time effect, with reduction in stress (p < 0.001), improvement in mental health-related quality of life (p = 0.032), reduction in binge eating severity (p < 0.001), and also in global ED symptoms scores (p < 0.001), with the significant changes found at end of treatment and sustained at 12-month follow-up. However, no statistical significance was found for differences between the interventions in any of the outcomes measured. Despite a high BMI, most participants (> 75%) had blood test results for glucose, insulin, triglycerides and cholesterol within the normal range, and 52% were within the normal range for the physical component of quality of life at baseline with no change during the trial period. CONCLUSION Integrating weight and ED management resulted in comparable outcomes to ED therapy alone. Although adding weight management to an ED intervention had no adverse effects on psychological outcomes, it also had no beneficial effect on metabolic outcomes. Therefore, more intense weight management strategies may be required where indicated to improve metabolic outcomes. Safety will need to be concurrently investigated. TRIAL REGISTRATION US National Institutes of Health clinical trial registration number NCT02464345 , date of registration 08/06/2015. Changes to the present paper from the published protocol paper (Trials 18:578, 2015) and as reported in the Trial registration (clinicaltrials.gov) are reported in Supplementary File 1.
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Effects of total diet replacement programs on mental well-being: A systematic review with meta-analyses.
Harris, RA, Fernando, HA, Seimon, RV, da Luz, FQ, Gibson, AA, Touyz, SW, Sainsbury, A
Obesity reviews : an official journal of the International Association for the Study of Obesity. 2022;(11):e13465
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Abstract
This systematic review with meta-analyses assessed the effects of total diet replacement (TDR) programs on mental well-being in clinical trial participants with a body mass index greater than or equal to 25 kg/m2 . TDR programs involve replacing all dietary requirements with nutritionally replete formula foods and are generally administered to induce rapid weight loss. To date, it is largely unclear what effects TDR programs may have on mental well-being, particularly in the long-term. To address this, we screened 25,976 references across six databases and extracted 35 publications. These 35 publications provided sufficient data to evaluate the effects of TDR programs on depression, anxiety, stress, positive affect, negative affect, vitality, role-emotional, social functioning, mental health, mental composite summary score, self-esteem, and general psychological health in 24 meta-analyses. Due to the lack of research comparing TDR programs to comparator groups, 22 of our 24 meta-analyses explored change in these mental well-being sub-domains over time in TDR programs without comparators. Specifically, we assessed the change from pre-diet (before the TDR program) to either post-diet (up to and including two months after the TDR program); and/or follow-up (more than two months after the TDR program). For depression and anxiety, we were also able to assess the change from pre-diet to mid-diet (which fell within two weeks of the diet half-way point). The remaining two meta-analyses assessed the difference in depression scores between a TDR group and a food-based comparator group from pre-diet to post-diet and from pre-diet to follow-up. Across all meta-analyses, our results found no marked adverse effects of TDR programs on any mental well-being sub-domain. In fact, clear improvements were observed for depression, anxiety, stress, vitality, role-emotional, and social functioning at post-diet. Interestingly, the improvements for depression, vitality and role-emotional were maintained at follow-up. All improvements were observed in meta-analyses without comparators. While the two comparator-based meta-analyses showed no difference between TDR programs and food-based diets in depression symptoms, there was low statistical power. For all meta-analyses containing three or more independent samples, we constructed prediction intervals to determine the range within which the mean of the true effects may fall for future populations. While these prediction intervals varied between sub-domains, we found that mean depression scores are only likely to increase (i.e., depression will worsen) in less than 3% of future TDR interventions which meet our inclusion/exclusion criteria. Taken together, we concluded that for adults with a body mass index greater than or equal to 25 kg/m2 , TDR programs are unlikely to lead to marked adverse effects on mental well-being. These findings do not support the exclusion of participants from trials or interventions involving TDR programs based on concerns that these programs may adversely affect mental well-being. In fact, by excluding these participants, they may be prevented from improving their metabolic health and mental well-being.
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Efficacy of dietary supplements containing isolated organic compounds for weight loss: a systematic review and meta-analysis of randomised placebo-controlled trials.
Bessell, E, Maunder, A, Lauche, R, Adams, J, Sainsbury, A, Fuller, NR
International journal of obesity (2005). 2021;(8):1631-1643
Abstract
BACKGROUND/OBJECTIVES A systematic review with meta-analysis was conducted to synthesise evidence on the efficacy of dietary supplements containing isolated organic compounds for weight loss. SUBJECTS/METHODS Four electronic databases (Medline, Embase, Web of Science, Cinahl) were searched until December 2019. Sixty-seven randomised placebo-controlled trials of dietary supplements containing isolated organic compounds for weight loss were included. Meta-analyses were conducted for chitosan, glucomannan, conjugated linoleic acid and fructans, comparing mean weight difference post-intervention between participants receiving the dietary supplement or placebo. RESULTS Statistically significant weight differences compared to placebo were observed for chitosan (-1.84 kg; 95% confidence interval [CI] -2.79, -0.88; p < 0.01), glucomannan (-1.27 kg; 95%CI -2.45, -0.09; p = 0.04), and conjugated linoleic acid (-1.08 kg; 95%CI -1.61, -0.55; p < 0.01). None met our threshold for clinical significance (≥2.5 kg). There was no statistically significant effect on weight for fructans compared to placebo (p = 0.24). For dietary supplements with an inadequate number of trials for meta-analysis, a statistically and borderline clinically significant weight difference compared to placebo was found for modified cellulose, manno-oligosaccharides (in males), blood orange juice extract, and three multiple-ingredient dietary supplements. These were only reported in one trial of each. Thus, more evidence is needed before recommending them for weight loss. CONCLUSIONS While some dietary supplements containing isolated organic compounds warrant further investigation to determine efficacy and safety, there is currently insufficient evidence to recommend any of these dietary supplements for weight loss.
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A Pilot Randomized Controlled Trial of a Partial Meal Replacement Preconception Weight Loss Program for Women with Overweight and Obesity.
Muirhead, R, Kizirian, N, Lal, R, Black, K, Prys-Davies, A, Nassar, N, Baur, L, Sainsbury, A, Sweeting, A, Markovic, T, et al
Nutrients. 2021;(9)
Abstract
About half of Australian women have a body mass index in the overweight or obese range at the start of pregnancy, with serious consequences including preterm birth, gestational hypertension and diabetes, caesarean section, stillbirth, and childhood obesity. Trials to limit weight gain during pregnancy have had limited success and reducing weight before pregnancy has greater potential to improve outcomes. The PreBabe Pilot study was a randomised controlled pilot trial to assess the feasibility, acceptability and potential weight loss achieved using a commercial online partial meal replacement program, (MR) vs. telephone-based conventional dietary advice, (DA) for pre-conception weight-loss over a 10-week period. Women 18-40 years of age with a BMI ≥ 25 kg/m2 planning pregnancy within the next 6 to 12 months were included in the study. All participants had three clinic visits with a dietitian and one obstetric consultation. In total, 50 women were enrolled in the study between June 2018 and October 2019-26 in MR and 24 in DA. Study retention at the end of 10 week intervention 81% in the MR arm and 75% in the DA arm. In the-intention-to-treat analysis, women using meal replacements lost on average 5.4 ± 3.1% body weight compared to 2.3 ± 4.2% for women receiving conventional advice (p = 0.029). Over 80% of women in the MR arm rated the support received as excellent, compared to 39% in the DA arm (p < 0.001). Women assigned to the MR intervention were more likely to achieve pregnancy within 12 months of the 10 week intervention (57% (12 of 21) women assigned to MR intervention vs. 22% (4 of 18) assigned to the DA group (p = 0.049) became pregnant). The findings suggest that a weight loss intervention using meal replacements in the preconception period was acceptable and may result in greater weight loss than conventional dietary advice alone.
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A 1-week diet break improves muscle endurance during an intermittent dieting regime in adult athletes: A pre-specified secondary analysis of the ICECAP trial.
Peos, JJ, Helms, ER, Fournier, PA, Krieger, J, Sainsbury, A
PloS one. 2021;(2):e0247292
Abstract
Athletes undergoing energy restriction for weight/fat reduction sometimes apply 'diet breaks' involving increased energy intake, but there is little empirical evidence of effects on outcomes. Twenty-six resistance-trained athletes (11/26 or 42% female) who had completed 12 weeks of intermittent energy restriction participated in this study. Participants had a mean (SD) age of 29.3 (6.4) years, a weight of 72.7 (15.9) kg, and a body fat percentage of 21.3 (7.5) %. During the 1-week diet break, energy intake was increased (by means of increased carbohydrate intake) to predicted weight maintenance requirements. While the 1-week diet break had no significant effect on fat mass, it led to small but significant increases in mean body weight (0.6 kg, P<0.001), fat-free mass (0.7 kg, P<0.001) and in resting energy expenditure, from a mean (and 95% confidence interval) of 7000 (6420 to 7580) kJ/day to 7200 (6620 to 7780) kJ/day (P = 0.026). Overall, muscle endurance in the legs (but not arms) improved after the diet break, including significant increases in the work completed by the quadriceps and hamstrings in a maximum-effort 25-repetition set, with values increasing from 2530 (2170 to 2890) J to 2660 (2310 to 3010) J (P = 0.018) and from 1280 (1130 to 1430) J to 1380 (1220 to 1540) J (P = 0.018) following the diet break, respectively. However, muscle strength did not change. Participants reported significantly lower sensations of hunger (P = 0.017), prospective consumption (P = 0.020) and irritability (P = 0.041) after the diet break, and significantly higher sensations of fullness (P = 0.002), satisfaction (P = 0.002), and alertness (P = 0.003). In summary, a 1-week diet break improved muscle endurance in the legs and increased mental alertness, and reduced appetite and irritability. With this considered, it may be wise for athletes to coordinate diet breaks with training sessions that require muscle endurance of the legs and/or mental focus, as well as in the latter parts of a weight loss phase when increases in appetite might threaten dietary adherence. Trial registration: Australian New Zealand Clinical Trials Registry Reference Number: ACTRN12618000638235 anzctr.org.au.
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Integrated weight loss and cognitive behavioural therapy (CBT) for the treatment of recurrent binge eating and high body mass index: a randomized controlled trial.
Palavras, MA, Hay, P, Mannan, H, da Luz, FQ, Sainsbury, A, Touyz, S, Claudino, AM
Eating and weight disorders : EWD. 2021;(1):249-262
Abstract
PURPOSE The association between binge eating and obesity is increasing. Treatments for disorders of recurrent binge eating comorbid with obesity reduce eating disorder (ED) symptoms, but not weight. This study investigated the efficacy and safety of introducing a weight loss intervention to the treatment of people with disorders of recurrent binge eating and a high body mass index (BMI). METHODS A single-blind randomized controlled trial selected adults with binge eating disorder or bulimia nervosa and BMI ≥ 27 to < 40 kg/m2. The primary outcome was sustained weight loss at 12-month follow-up. Secondary outcomes included ED symptoms. Mixed effects models analyses were conducted using multiple imputed datasets in the presence of missing data. RESULTS Ninety-eight participants were randomized to the Health Approach to Weight Management and Food in Eating Disorders (HAPIFED) or to the Cognitive Behavioural Therapy-Enhanced (CBT-E). No between-group differences were found for percentage of participants achieving weight loss or secondary outcomes, except for reduction of purging behaviour, which was greater with HAPIFED (p = 0.016). Binge remission rates specifically at 12-month follow-up favoured HAPIFED (34.0% vs 16.7%; p = 0.049). Overall, significant improvements in the reduction of ED symptoms were seen in both groups and these were sustained at the 12-month follow-up. CONCLUSION HAPIFED was not superior to CBT-E in promoting clinically significant weight loss and was not significantly different in reducing most ED symptoms. No harm was observed with HAPIFED, in that no worsening of ED symptoms was observed. Further studies should test approaches that target both the management of ED symptoms and the high BMI. LEVEL OF EVIDENCE Level I, randomized controlled trial TRIAL REGISTRATION US National Institutes of Health clinical trial registration number NCT02464345, date of registration 1 June 2015.