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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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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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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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Diet Quality following Total Meal Replacement Compared with Food-Based Weight-Loss Diets in Postmenopausal Women with Obesity: A Secondary Analysis of the TEMPO Diet Trial.
Pattinson, AL, Seimon, RV, Harper, C, Nassar, N, Grech, A, Santoso, EA, Franklin, J, Inan-Eroglu, E, Gibson, AA, Sainsbury, A
The Journal of nutrition. 2021;(11):3299-3312
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BACKGROUND Severely energy-restricted diets that utilize meal-replacement products are the most effective dietary treatment for obesity. However, there are concerns they may fail to educate individuals on how to adopt a healthy food-based diet after weight loss. OBJECTIVES The aim of this research was to compare changes in diet quality following total meal replacement compared with food-based weight-loss diets. METHODS In this secondary analysis of a randomized controlled trial, 79 postmenopausal women aged 45-65 y, with a BMI (in kg/m2) of 30-40, were randomly assigned to either a total meal-replacement diet (energy intake restricted by 65-75% relative to requirements) for 16 wks, followed by a food-based diet (energy intake restricted by 25-35% relative to requirements) until 52 wks, or the food-based diet for the entire 52-wk period. Diet quality was scored at baseline and 52 wks using the Healthy Eating Index for Australian Adults, with score changes compared between groups using an independent t test. RESULTS Diet quality improved from baseline in both groups, but less so in the total meal-replacement group, with a mean (SD) increase of 3.6 (10.8) points compared with 11.8 (13.9) points in the food-based group, resulting in a mean between-group difference of -8.2 (P = 0.004; 95% CI: -13.8, -2.7) points. This improvement in diet quality within both groups was mostly driven by a reduction in the intake of discretionary foods. Intake remained below the recommendations at 52 wks for 4 of the 5 food groups in both dietary interventions. CONCLUSIONS In postmenopausal women with obesity, weight-loss interventions that involve either a total meal-replacement diet or a food-based diet both improve diet quality, however, not sufficiently to meet recommendations. This highlights the importance of addressing diet quality as a part of all dietary weight-loss interventions. This trial is registered with the Australia and New Zealand Clinical Trials Registry as 12612000651886.
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Effect of Ramadan Fasting on Weight and Body Composition in Healthy Non-Athlete Adults: A Systematic Review and Meta-Analysis.
Fernando, HA, Zibellini, J, Harris, RA, Seimon, RV, Sainsbury, A
Nutrients. 2019;11(2)
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Ramadan is the Islamic tradition of fasting for one month from sunrise to sunset. Generally, Ramadan is known to impact weight. This systematic review and meta-analysis specifically evaluated the effects of Ramadan on both weight and body mass (fat mass and fat-free mass), pre and post fasting, and in the context of there being no attempt to influence physical activity or diet. The meta-analysis was conducted on 70 publications, 90 comparison groups and 2947 participants. Data was also extracted for diverse sub-groups such as overweight/obese, gender and geographical location. The results showed that Ramadan promoted a significant reduction in weight pre and post fasting across all participants, and that the greater the BMI prior to Ramadan fasting, the greater the weight loss. No significant differences were noted between genders. Weight loss was significant in the Middle East + North Africa, South Asia and South East Asia, but not in Westernized countries. Ramadan fasting promoted a transient reduction in fat mass as a percentage of weight, and absolute fat mass, but quickly returned to pre-fasting levels at follow-up 2-5 weeks later. A significant reduction in fat-free mass was also noted but 30% less than total fat mass. There was insufficient data to analysis the possible impact of physical activity. The authors conclude that Ramadan represents an opportunity for promoting weight and fat loss for people with overweight or obesity but requires strategies for long-term maintenance
Abstract
BACKGROUND Ramadan involves one month of fasting from sunrise to sunset. In this meta-analysis, we aimed to determine the effect of Ramadan fasting on weight and body composition. METHODS In May 2018, we searched six databases for publications that measured weight and body composition before and after Ramadan, and that did not attempt to influence physical activity or diet. RESULTS Data were collected from 70 publications (90 comparison groups, 2947 participants). There was a significant positive correlation between starting body mass index and weight lost during the fasting period. Consistently, there was a significant reduction in fat percentage between pre-Ramadan and post-Ramadan in people with overweight or obesity (-1.46 (95% confidence interval: -2.57 to -0.35) %, p = 0.010), but not in those of normal weight (-0.41 (-1.45 to 0.63) %, p = 0.436). Loss of fat-free mass was also significant between pre-Ramadan and post-Ramadan, but was about 30% less than loss of absolute fat mass. At 2⁻5 weeks after the end of Ramadan, there was a return towards, or to, pre-Ramadan measurements in weight and body composition. CONCLUSIONS Even with no advice on lifestyle changes, there are consistent-albeit transient-reductions in weight and fat mass with the Ramadan fast, especially in people with overweight or obesity.
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Effect of Weight Loss via Severe vs Moderate Energy Restriction on Lean Mass and Body Composition Among Postmenopausal Women With Obesity: The TEMPO Diet Randomized Clinical Trial.
Seimon, RV, Wild-Taylor, AL, Keating, SE, McClintock, S, Harper, C, Gibson, AA, Johnson, NA, Fernando, HA, Markovic, TP, Center, JR, et al
JAMA network open. 2019;(10):e1913733
Abstract
IMPORTANCE Severely energy-restricted diets are the most effective dietary obesity treatment. However, there are concerns regarding potential adverse effects on body composition. OBJECTIVE To compare the long-term effects of weight loss via severe vs moderate energy restriction on lean mass and other aspects of body composition. DESIGN, SETTING, AND PARTICIPANTS The Type of Energy Manipulation for Promoting Optimum Metabolic Health and Body Composition in Obesity (TEMPO) Diet Trial was a 12-month, single-center, randomized clinical trial. A total of 101 postmenopausal women, aged 45 to 65 years with body mass index (calculated as weight in kilograms divided by height in meters squared) from 30 to 40, who were at least 5 years after menopause, had fewer than 3 hours of structured physical activity per week, and lived in the Sydney metropolitan area of New South Wales, Australia, were recruited between March 2013 and July 2016. Data analysis was conducted between October 2018 and August 2019. INTERVENTION Participants were randomized to either 12 months of moderate (25%-35%) energy restriction with a food-based diet (moderate intervention) or 4 months of severe (65%-75%) energy restriction with a total meal replacement diet followed by moderate energy restriction for an additional 8 months (severe intervention). Both interventions had a prescribed protein intake of 1.0 g/kg of actual body weight per day, and physical activity was encouraged but not supervised. MAIN OUTCOMES AND MEASURES The primary outcome was whole-body lean mass at 12 months after commencement of intervention. Secondary outcomes were body weight, thigh muscle area and muscle function (strength), bone mineral density, and fat mass and distribution, measured at 0, 4, 6, and 12 months. RESULTS A total of 101 postmenopausal women were recruited (mean [SD] age, 58.0 [4.2] years; mean [SD] weight, 90.8 [9.1] kg; mean [SD] body mass index, 34.4 [2.5]). Compared with the moderate group at 12 months, the severe group lost more weight (effect size, -6.6 kg; 95% CI, -8.2 to -5.1 kg), lost more whole-body lean mass (effect size, -1.2 kg; 95% CI, -2.0 to -0.4 kg), and lost more thigh muscle area (effect size, -4.2 cm2; 95% CI, -6.5 to -1.9 cm2). However, decreases in whole-body lean mass and thigh muscle area were proportional to total weight loss, and there was no difference in muscle (handgrip) strength between groups. Total hip bone mineral density (effect size, -0.017 g/cm2; 95% CI, -0.029 to -0.005 g/cm2), whole-body fat mass (effect size, -5.5 kg; 95% CI, -7.1 to -3.9 kg), abdominal subcutaneous adipose tissue (effect size, -1890 cm3; 95% CI, -2560 to -1219 cm3), and visceral adipose tissue (effect size, -1389 cm3; 95% CI, -1748 to -1030 cm3) loss were also greater for the severe group than for the moderate group at 12 months. CONCLUSIONS AND RELEVANCE Severe energy restriction had no greater adverse effect on relative whole-body lean mass or handgrip strength compared with moderate energy restriction and was associated with 2-fold greater weight and fat loss over 12 months. However, there was significantly greater loss of total hip bone mineral density with severe vs moderate energy restriction. Therefore, caution is necessary when implementing severe energy restriction in postmenopausal women, particularly those with osteopenia or osteoporosis. TRIAL REGISTRATION anzctr.org.au Identifier: 12612000651886.
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Recruitment Strategies for a Randomised Controlled Trial Comparing Fast Versus Slow Weight Loss in Postmenopausal Women with Obesity-The TEMPO Diet Trial.
Hsu, MSH, Harper, C, Gibson, AA, Sweeting, AN, McBride, J, Markovic, TP, Caterson, ID, Byrne, NM, Sainsbury, A, Seimon, RV
Healthcare (Basel, Switzerland). 2018;(3)
Abstract
Current research around effective recruitment strategies for clinical trials of dietary obesity treatments have largely focused on younger adults, and thus may not be applicable to older populations. The TEMPO Diet Trial (Type of Energy Manipulation for Promoting optimal metabolic health and body composition in Obesity) is a randomised controlled trial comparing the long-term effects of fast versus slow weight loss on body composition and cardio-metabolic health in postmenopausal women with obesity. This paper addresses the recruitment strategies used to enrol participants into this trial and evaluates their relative effectiveness. 101 post-menopausal women aged 45⁻65 years, with a body mass index of 30⁻40 kg/m² were recruited and randomised to either fast or slow weight loss. Multiple strategies were used to recruit participants. The total time cost (labour) and monetary cost per randomised participant from each recruitment strategy was estimated, with lower values indicating greater cost-effectiveness and higher values indicating poorer cost-effectiveness. The most cost-effective recruitment strategy was word of mouth, followed (at equal second place) by free publicity on TV and radio, and printed advertorials, albeit these avenues only yielded 26/101 participants. Intermediate cost-effective recruitment strategies were flyer distribution at community events, hospitals and a local tertiary education campus, internet-based strategies, and clinical trial databases and intranets, which recruited a further 40/101 participants. The least cost-effective recruitment strategy was flyer distribution to local health service centres and residential mailboxes, and referrals from healthcare professionals were not effective. Recruiting for clinical trials involving postmenopausal women could benefit from a combination of recruitment strategies, with an emphasis on word of mouth and free publicity via radio, TV, and print media, as well as strategic placement of flyers, supplemented with internet-based strategies, databases and intranets if a greater yield of participants is needed.
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Rationale for novel intermittent dieting strategies to attenuate adaptive responses to energy restriction.
Sainsbury, A, Wood, RE, Seimon, RV, Hills, AP, King, NA, Gibson, AA, Byrne, NM
Obesity reviews : an official journal of the International Association for the Study of Obesity. 2018;:47-60
Abstract
Eating patterns involving intermittent energy restriction (IER) include 'intermittent fasting' where energy intake is severely restricted for several 'fasting' days per week, with 'refeeding' days (involving greater energy intake than during fasting days) at other times. Intermittent fasting does not improve weight loss compared to continuous energy restriction (CER), where energy intake is restricted every day. We hypothesize that weight loss from IER could be improved if refeeding phases involved restoration of energy balance (i.e. not ongoing energy restriction, as during intermittent fasting). There is some evidence in adults with overweight or obesity showing that maintenance of a lower weight may attenuate (completely or partially) some of the adaptive responses to energy restriction that oppose ongoing weight loss. Other studies show some adaptive responses persist unabated for years after weight loss. Only five randomized controlled trials in adults with overweight or obesity have compared CER with IER interventions that achieved energy balance (or absence of energy restriction) during refeeding phases. Two reported greater weight loss than CER, whereas three reported similar weight loss between interventions. While inconclusive, it is possible that achieving energy balance (i.e. avoiding energy restriction or energy excess) during refeeding phases may be important in realizing the potential of IER.
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Experiences of using very low energy diets for weight loss by people with overweight or obesity: a review of qualitative research.
Harper, C, Maher, J, Grunseit, A, Seimon, RV, Sainsbury, A
Obesity reviews : an official journal of the International Association for the Study of Obesity. 2018;(10):1412-1423
Abstract
Although very low energy diets (VLEDs) are the most successful non-surgical, non-pharmacological treatment for obesity, they are underutilized, and little is known about experiences of people using VLEDs for weight loss. This systematic review synthesizes qualitative studies investigating participants' experiences of undertaking a VLED composed of total meal replacement products to lose weight. Of the 4,911 articles screened, three studies met criteria for inclusion. Thematic synthesis was used to analyse the study findings. Health and appearance were the main motivators to use a VLED for weight loss. Adherence was facilitated by group support meetings, rapid weight loss and ease of use of the diet. Being part of a clinical trial gave a sense of accountability and further reason to adhere to a VLED, and the VLED itself was well accepted by users. Barriers to adherence, such as temptations and social occasions, were overcome by avoidance and distraction strategies. In conclusion, this qualitative synthesis of users' experiences of VLEDs shows that VLEDs are well accepted and positively viewed by users. More in-depth research could facilitate understanding of how this weight loss strategy influences the weight maintenance period, in order to facilitate better long-term results.
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Rationale and Protocol for a Randomized Controlled Trial Comparing Fast versus Slow Weight Loss in Postmenopausal Women with Obesity-The TEMPO Diet Trial.
Seimon, RV, Gibson, AA, Harper, C, Keating, SE, Johnson, NA, da Luz, FQ, Fernando, HA, Skilton, MR, Markovic, TP, Caterson, ID, et al
Healthcare (Basel, Switzerland). 2018;(3)
Abstract
Very low energy diets (VLEDs), commonly achieved by replacing all food with meal replacement products and which result in fast weight loss, are the most effective dietary obesity treatment available. VLEDs are also cheaper to administer than conventional, food-based diets, which result in slow weight loss. Despite being effective and affordable, these diets are underutilized by healthcare professionals, possibly due to concerns about potential adverse effects on body composition and eating disorder behaviors. This paper describes the rationale and detailed protocol for the TEMPO Diet Trial (Type of Energy Manipulation for Promoting optimal metabolic health and body composition in Obesity), in a randomized controlled trial comparing the long-term (3-year) effects of fast versus slow weight loss. One hundred and one post-menopausal women aged 45⁻65 years with a body mass index of 30⁻40 kg/m² were randomized to either: (1) 16 weeks of fast weight loss, achieved by a total meal replacement diet, followed by slow weight loss (as for the SLOW intervention) for the remaining time up until 52 weeks ("FAST" intervention), or (2) 52 weeks of slow weight loss, achieved by a conventional, food-based diet ("SLOW" intervention). Parameters of body composition, cardiometabolic health, eating disorder behaviors and psychology, and adaptive responses to energy restriction were measured throughout the 3-year trial.
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Relation between weight loss and causes of death in patients with cardiovascular disease: finding from the SCOUT trial.
Maggioni, AP, Caterson, ID, Urso, R, Coutinho, W, Finer, N, Van Gaal, L, Legler, UF, Sharma, AM, Seimon, RV, Sweeting, A, et al
Journal of cardiovascular medicine (Hagerstown, Md.). 2017;(3):144-151
Abstract
AIMS: Obesity is associated with an increased incidence of mortality. The Sibutramine Cardiovascular Outcomes (SCOUT) trial can provide the first evidence of the effect of intentional weight loss on mortality in an obese population at high risk. METHODS SCOUT was a randomized, double-blind, placebo-controlled trial testing sibutramine vs. placebo. Eligibility for the trial required both men and women aged at least 55 years, with BMI of at least 27 kg/m and 45 kg/m or less. Study participants with type 2 diabetes mellitus (T2DM) only should have at least one other risk factor defined as hypertension, dyslipidaemia, smoking, or diabetic nephropathy, and/or they had a history of cardiovascular disease. Study participants were stratified in three groups: patients with T2DM, patients with a prior cardiovascular event but without diabetes, and patients with both T2DM and a prior cardiovascular event.The relationship between weight loss and mortality (all-cause, cardiovascular, and noncardiovascular) was investigated with Cox regression models. RESULTS The main study showed that all-cause mortality was not different in patients allocated to sibutramine or placebo. This ancillary analysis demonstrates that there is a general trend showing higher mortality in patients with the greatest weight loss (weight reduction >10 kg) and in those with increasing weight (>1 kg). If integrated weight loss (area under the curve from baseline to 12 months) is used, these observations are confirmed. The impact of substantial weight loss on mortality is marked in those dying of noncardiovascular causes, specifically cancer. CONCLUSION The relationship between weight change and mortality differs for cardiovascular and noncardiovascular mortality.