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Combining Short-Term Interval Training with Caloric Restriction Improves ß-Cell Function in Obese Adults.
Francois, ME, Gilbertson, NM, Eichner, NZM, Heiston, EM, Fabris, C, Breton, M, Mehaffey, JH, Hassinger, T, Hallowell, PT, Malin, SK
Nutrients. 2018;10(6)
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The development of type 2 diabetes is characterised by insulin resistance and dysfunction of the pancreas. Over time, loss of function of the ß-cells of the pancreas leads to impaired tolerance of blood sugar and type 2 diabetes. Low-calorie diets have been shown to improve blood sugar regulation, but it is unclear what impact interval exercise has in addition to a low-calorie diet. This study tested the hypothesis that combining interval exercise with a low-calorie diet would enhance pancreatic function compared to a low calorie diet alone in adults with obesity. Twenty-six obese adults were assigned to 2 weeks of a LCD (1200 kcal/day), using meal replacement shakes for breakfast and lunch. Half the group also underwent 60 minutes of interval training a day; after each session they received a 350 kcal shake to compensate for the calories burned during training. A series of blood tests was carried out to measure glucose tolerance and insulin secretion rates. Combining a low calorie diet with interval training reduced glucose and insulin secretion rates, whereas the low calorie diet alone did not. Both interventions improved insulin sensitivity. The authors concluded that the data supports combining low calorie diets with interval training to preserve pancreatic function and prevent type 2 diabetes.
Abstract
Although low-calorie diets (LCD) improve glucose regulation, it is unclear if interval exercise (INT) is additive. We examined the impact of an LCD versus LCD + INT training on ß-cell function in relation to glucose tolerance in obese adults. Twenty-six adults (Age: 46 ± 12 year; BMI 38 ± 6 kg/m²) were randomized to 2-week of LCD (~1200 kcal/day) or energy-matched LCD + INT (60 min/day alternating 3 min at 90 and 50% HRpeak). A 2 h 75 g oral glucose tolerance test (OGTT) was performed. Insulin secretion rates (ISR) were determined by deconvolution modeling to assess glucose-stimulated insulin secretion ([GSIS: ISR/glucose total area under the curve (tAUC)]) and ß-cell function (Disposition Index [DI: GSIS/IR]) relative to skeletal muscle (Matsuda Index), hepatic (HOMA-IR) and adipose (Adipose-IRfasting) insulin resistance (IR). LCD + INT, but not LCD alone, reduced glucose and total-phase ISR tAUC (Interactions: p = 0.04 and p = 0.05, respectively). Both interventions improved skeletal muscle IR by 16% (p = 0.04) and skeletal muscle and hepatic DI (Time: p < 0.05). Improved skeletal muscle DI was associated with lower glucose tAUC (r = -0.57, p < 0.01). Thus, LCD + INT improved glucose tolerance more than LCD in obese adults, and these findings relate to ß-cell function. These data support LCD + INT for preserving pancreatic function for type 2 diabetes prevention.
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Calorie restriction regime enhances physical performance of trained athletes.
Pons, V, Riera, J, Capó, X, Martorell, M, Sureda, A, Tur, JA, Drobnic, F, Pons, A
Journal of the International Society of Sports Nutrition. 2018;15:12
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Athletes commonly aim to reduce body weight to improve their strength-to-mass ratio. In this study caloric restriction (CR) of 33% was achieved through alternate day fasting in trained athletes, which the authors hypothesised to be more easy to adhere to than daily reduced energy intake. The macronutrient composition remained the same as prior to calorie reduction. Study participants lost an average of 4.4% in body weight over 6 weeks, most of which came from fat, 15.1%. Despite also losing some lean mass (2.9%), exercise performance of the athletes improved, as did energy efficiency, possibly due to increased mitochondrial efficiency. Nutritional record analysis revealed that athletes ingested less than the RDA for several nutrients prior to the CR intervention, and intake was even lower with CR. The authors conclude that CR may be a good way for athletes to achieve weight loss as, unlike other body weight reduction techniques, the alternate day fasting CR improved physical performance. They suggest though that to ensure adequate micronutrient intake, supplementation may be required.
Abstract
BACKGROUND Caloric restriction induces mitochondrial biogenesis and improves physical fitness in rodents. We aimed to provide evidence of how caloric restriction affects the body composition and physical performance of trained athletes and to evaluate the possible impact of an every-other-day feeding diet on nutritional deficiencies of micronutrients and essential fatty acids. METHODS The study was performed with 12 healthy male athletes by carrying out a 33% caloric restriction with respect to their usual diet. Athletes performed a maximal exercise stress test both before and after the caloric restriction period. Blood samples were taken before and after the caloric restriction at basal conditions and 30 min post-exercise. Although energy intake was reduced by about 33%, the contribution of carbohydrates, proteins, and lipids to total energy intake during the caloric restriction was similar to the original diet. RESULTS The caloric restriction reduced the daily specific micronutrient intake to values lower than 90% of recommended dietary allowances. No effects were observed in blood parameters related to iron metabolism and tissue damage, glucose levels, lipid profiles, or erythrocyte fatty acid composition. In addition, oxidative damage markers decreased after the nutritional intervention. The caloric restriction intervention significantly reduced body weight and trunk, arm, and leg weights; it also caused a decrease in fat and lean body mass, the energy expenditure rate when performing a maximal exercise stress test, and the energy cost to run one meter at various exercise intensities. Furthermore, the intervention ameliorated the onset of the anaerobic phase of exercise. CONCLUSION A caloric restriction improves athletes' performance and energy efficiency, but reduces the daily intake of micronutrients; so, when caloric restriction programs are implemented micronutrient supplementation should be considered. TRIAL REGISTRATION The project was registered at ClinicalTrials.gov (NCT02533479).
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Resistance Training Prevents Muscle Loss Induced by Caloric Restriction in Obese Elderly Individuals: A Systematic Review and Meta-Analysis.
Sardeli, AV, Komatsu, TR, Mori, MA, Gáspari, AF, Chacon-Mikahil, MPT
Nutrients. 2018;10(4)
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Caloric restriction (55% carbohydrate, 15% protein, 30% fat) is associated with increased lifespans and the attenuation of the harmful effects of aging. Furthermore, it has been shown that resistance training increases lean body mass, promotes strength, and attenuates muscle loss and function in elderly people. The aim of the study is to determine the level of lean body mass that can be preserved when resistance training is associated with caloric restriction interventions in elderly obese humans. The study is a meta-analysis, based on data from randomised-controlled trials. The participants were older adults or elderly people with a mean age > 57 year. Results indicate that caloric restriction associated with resistance training prevents 93% lean body mass loss induced by caloric restriction. Authors conclude that caloric restriction with resistance training almost stopped caloric restriction induced lean body mass loss completely.
Abstract
It remains unclear as to what extent resistance training (RT) can attenuate muscle loss during caloric restriction (CR) interventions in humans. The objective here is to address if RT could attenuate muscle loss induced by CR in obese elderly individuals, through summarized effects of previous studies. Databases MEDLINE, Embase and Web of Science were used to perform a systematic search between July and August 2017. Were included in the review randomized clinical trials (RCT) comparing the effects of CR with (CRRT) or without RT on lean body mass (LBM), fat body mass (FBM), and total body mass (BM), measured by dual-energy X-ray absorptiometry, on obese elderly individuals. The six RCTs included in the review applied RT three times per week, for 12 to 24 weeks, and most CR interventions followed diets of 55% carbohydrate, 15% protein, and 30% fat. RT reduced 93.5% of CR-induced LBM loss (0.819 kg [0.364 to 1.273]), with similar reduction in FBM and BM, compared with CR. Furthermore, to address muscle quality, the change in strength/LBM ratio tended to be different (p = 0.07) following CRRT (20.9 ± 23.1%) and CR interventions (−7.5 ± 9.9%). Our conclusion is that CRRT is able to prevent almost 100% of CR-induced muscle loss, while resulting in FBM and BM reductions that do not significantly differ from CR.
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Efficacy of ketogenic diet on body composition during resistance training in trained men: a randomized controlled trial.
Vargas, S, Romance, R, Petro, JL, Bonilla, DA, Galancho, I, Espinar, S, Kreider, RB, Benítez-Porres, J
Journal of the International Society of Sports Nutrition. 2018;15(1):31
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This randomised controlled trial investigated the effects of a ketogenic diet on body composition in bodybuilders. 24 healthy body-builders were randomised to either a ketogenic diet (KD), non-ketogenic diet (NKD) or to control group (CG). During the trial period, both the KD and the NKD group received a surplus of calories and the same amount of protein, 2g/kg body weight per day to promote anabolic activity. Macronutrient ratios were carbohydrate 55%, protein 20% and fat 25% in the NKD group versus <10% carbohydrate, 20% protein and 70% fat in the KD group. Participants could eat when and how often they wanted to and both groups carried out the same training programme. After eight weeks the KD group showed significantly lower total fat mass and visceral (abdominal) fat, but no gain in either total body weight or lean mass. The NKD group, on the other hand, gained lean mass and body weight, but saw no changes in total or visceral fat mass. No significant changes in body composition were observed in the CG.
Abstract
BACKGROUND Ketogenic diets (KD) have become a popular method of promoting weight loss. More recently, some have recommended that athletes adhere to ketogenic diets in order to optimize changes in body composition during training. This study evaluated the efficacy of an 8-week ketogenic diet (KD) during energy surplus and resistance training (RT) protocol on body composition in trained men. METHODS Twenty-four healthy men (age 30 ± 4.7 years; weight 76.7 ± 8.2 kg; height 174.3 ± 19.7 cm) performed an 8-week RT program. Participants were randomly assigned to a KD group (n = 9), non-KD group (n = 10, NKD), and control group (n = 5, CG) in hyperenergetic condition. Body composition changes were measured by dual energy X-ray absorptiometry (DXA). Compliance with the ketosis state was monitored by measuring urinary ketones weekly. Data were analyzed using a univariate, multivariate and repeated measures general linear model (GLM) statistics. RESULTS There was a significant reduction in fat mass (mean change, 95% CI; p-value; Cohen's d effect size [ES]; - 0.8 [- 1.6, - 0.1] kg; p < 0.05; ES = - 0.46) and visceral adipose tissue (- 96.5 [- 159.0, - 34.0] g; p < 0.05; ES = - 0.84), while no significant changes were observed in the NKD and CG in fat mass (- 0,5 [- 1.2, 0.3] kg; p > 0.05; ES = - 0.17 and - 0,5 [- 2.4, 1.3] kg; p > 0.05; ES = - 0.12, respectively) or visceral adipose tissue (- 33.8 [- 90.4, 22.8]; p > 0.5; ES = - 0.17 and 1.7 [- 133.3, 136.7]; p > 0.05; ES = 0.01, respectively). No significant increases were observed in total body weight (- 0.9 [- 2.3, 0.6]; p > 0.05; ES = [- 0.18]) and muscle mass (- 0.1 [- 1.1,1.0]; p > 0,05; ES = - 0.04) in the KD group, but the NKD group showed increases in these parameters (0.9 [0.3, 1.5] kg; p < 0.05; ES = 0.18 and (1.3[0.5, 2.2] kg; p < 0,05; ES = 0.31, respectively). There were no changes neither in total body weight nor lean body mass (0.3 [- 1.2, 1.9]; p > 0.05; ES = 0.05 and 0.8 [- 0.4, 2.1]; p > 0.05; ES = 0.26, respectively) in the CG. CONCLUSION Our results suggest that a KD might be an alternative dietary approach to decrease fat mass and visceral adipose tissue without decreasing lean body mass; however, it might not be useful to increase muscle mass during positive energy balance in men undergoing RT for 8 weeks.
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Effects of Low Versus Moderate Glycemic Index Diets on Aerobic Capacity in Endurance Runners: Three-Week Randomized Controlled Crossover Trial.
Durkalec-Michalski, K, Zawieja, EE, Zawieja, BE, Jurkowska, D, Buchowski, MS, Jeszka, J
Nutrients. 2018;10(3)
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During athletic performance, adequate amounts of carbohydrates are required to prolong the onset of fatigue. Research on whether the glycaemic index (GI) of ingested carbohydrates effects performance has been explored but has produced equivocal results. The aim of this randomised crossover study was to assess the effect of low- and moderate- GI diets on the aerobic capacity and endurance performance in 21 runners. Participants consumed a low- and moderate- GI, high carbohydrate and nutrient balanced diets for three weeks each with a two-week washout period. Aerobic capacity and body composition were measured at the beginning and end of each diet period through various athletic performance tests. This study found that after a low-GI, high-carbohydrate diet, improvements were seen in time to exhaustion and running performance. Gas exchange was improved by both diets. The low-GI carbohydrate diet helped athletes to maintain a more stable blood glucose concentration during exertion tests. Based on these results the authors suggest considering GI when planning a diet for performance athletes, and also urge further research be completed to better understand the effects of long-term GI diets with regards to exercise performance.
Abstract
The glycemic index (GI) of ingested carbohydrates may influence substrate oxidation during exercise and athletic performance. Therefore, the aim of this study was to assess the effect of low- and moderate-GI three-week diets on aerobic capacity and endurance performance in runners. We conducted a randomized crossover feeding study of matched diets differing only in GI (low vs. moderate) in 21 endurance-trained runners. Each participant consumed both, low- (LGI) and moderate-GI (MGI) high-carbohydrate (~60%) and nutrient-balanced diets for three weeks each. At the beginning and end of each diet, participants had their aerobic capacity and body composition measured and performed a 12-min running test. After LGI, time to exhaustion during incremental cycling test (ICT) and distance covered in the 12-min run were significantly increased. The MGI diet led to an increase in maximal oxygen uptake ( V ˙ O₂max), but no performance benefits were found after the MGI diet. The LGI and MGI diets improved time and workload at gas exchange threshold (GET) during ICT. The results indicate that a three-week high-carbohydrate LGI diet resulted in a small but significant improvement in athletic performance in endurance runners. Observed increase in V ˙ O₂max on MGI diet did not affect performance.
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Does high-carbohydrate intake lead to increased risk of obesity? A systematic review and meta-analysis.
Sartorius, K, Sartorius, B, Madiba, TE, Stefan, C
BMJ open. 2018;8(2):e018449
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As overweight and obesity is rising globally, better understanding its cause is important to help with prevention and management of disease. The objective of this meta-analysis is to investigate the relationship between carbohydrate intake and obesity, particularly at the differences between low and high carbohydrate diets. Based on 22 articles that met the inclusion criteria, a high-carbohydrate diet, or increased proportion of energy intake in the form of carbohydrates, does not increase the risk of being obese. Based on these results, the authors iterate further studies are required to better understand obesity risk with regards different carbohydrate groups including refined versus unrefined carbohydrates.
Abstract
OBJECTIVES The present study aimed to test the association between high and low carbohydrate diets and obesity, and second, to test the link between total carbohydrate intake (as a percentage of total energy intake) and obesity. SETTING, PARTICIPANTS AND OUTCOME MEASURES We sought MEDLINE, PubMed and Google Scholar for observation studies published between January 1990 and December 2016 assessing an association between obesity and high-carbohydrate intake. Two independent reviewers selected candidate studies, extracted data and assessed study quality. RESULTS The study identified 22 articles that fulfilled the inclusion and exclusion criteria and quantified an association between carbohydrate intake and obesity. The first pooled strata (high-carbohydrate versus low-carbohydrate intake) suggested a weak increased risk of obesity. The second pooled strata (increasing percentage of total carbohydrate intake in daily diet) showed a weak decreased risk of obesity. Both these pooled strata estimates were, however, not statistically significant. CONCLUSIONS On the basis of the current study, it cannot be concluded that a high-carbohydrate diet or increased percentage of total energy intake in the form of carbohydrates increases the odds of obesity. A central limitation of the study was the non-standard classification of dietary intake across the studies, as well as confounders like total energy intake, activity levels, age and gender. Further studies are needed that specifically classify refined versus unrefined carbohydrate intake, as well as studies that investigate the relationship between high fat, high unrefined carbohydrate-sugar diets. PROSPERO REGISTRATION NUMBER CRD42015023257.
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Effects of Providing High-Fat versus High-Carbohydrate Meals on Daily and Postprandial Physical Activity and Glucose Patterns: a Randomised Controlled Trial.
Parr, EB, Devlin, BL, Callahan, MJ, Radford, BE, Blankenship, JM, Dunstan, DW, Hawley, JA
Nutrients. 2018;10(5)
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The timing of habitual meal consumption and composition is known to be an important factor in health status, particularly for blood glucose regulation. The aim of this randomised crossover study was to assess the effects of altering meal timing and diet composition on postprandial glucose and physical activity levels. Eight overweight or obese men with a sedentary lifestyle completed two 12-day measurement periods including a 7-day habitual period followed by a 5-day experimental period, with an 8-day washout period. The two conditions tested were a high-fat, low carbohydrate diet (HFD) and a high-carbohydrate, low-fat diet (HCD) and participants were instructed to consume meals at standardised times throughout both conditions. Body composition, oxygen consumption and blood glucose were measured at baseline and between each experimental condition. This trial found the provision of meals did not alter overall activity patterns or postprandial activity patterns. The authors observed increased sedentary activity across the day, and identify evening time as an important target for sedentary time to be minimised. Based on these results, the authors suggest that future dietary interventions consider habitual meal consumption and composition to best replicate real-world behaviours.
Abstract
We determined the effects of altering meal timing and diet composition on temporal glucose homeostasis and physical activity measures. Eight sedentary, overweight/obese men (mean ± SD, age: 36 ± 4 years; BMI: 29.8 ± 1.8 kg/m²) completed two × 12-day (12-d) measurement periods, including a 7-d habitual period, and then 5 d of each diet (high-fat diet [HFD]: 67:15:18% fat:carbohydrate:protein versus high-carbohydrate diet [HCD]: 67:15:18% carbohydrate:fat:protein) of three meals/d at ±30 min of 0800 h, 1230 h, and 1800 h, in a randomised order with an 8-d washout. Energy intake (EI), the timing of meal consumption, blood glucose regulation (continuous glucose monitor system (CGMS)), and activity patterns (accelerometer and inclinometer) were assessed across each 12-d period. Meal provision did not alter the patterns of reduced physical activity, and increased sedentary behaviour following dinner, compared with following breakfast and lunch. The HCD increased peak (+1.6 mmol/L, p < 0.001), mean (+0.5 mmol/L, p = 0.001), and total area under the curve (+670 mmol/L/min, p = 0.001), as well as 3-h postprandial meal glucose concentrations (all p < 0.001) compared with the HFD. In overweight/obese males, the provision of meals did not alter physical activity patterns, but did affect glycaemic control. Greater emphasis on meal timing and composition is required in diet and/or behaviour intervention studies to ensure relevance to real-world behaviours.
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Does adapted physical activity‑based rehabilitation improve mental and physical functioning? A randomized trial.
Røe, C, Preede, L, Dalen, H, Bautz-Holter, E, Nyquist, A, Sandvik, L, Saebu, M
European journal of physical and rehabilitation medicine. 2018;54(3):419-427
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Physical and mental functioning is reduced in people with chronic disability. Adapted physical activity (APA) programmes have been developed to facilitate physical activity in this population, but the mental effects have not yet been addressed. The aim of this study was to determine both the physical and mental effects of an APA programme in 202 patients with chronic disability. Participants were randomised to either join an in-patient APA rehabilitation programme or a waitlist control group. Those in the APA programme received 2-5 hours of guided activity every day for 6 days a week, as well as 1-3 hours of a social or cultural activities. Various questionnaires were completed at baseline and at the end of the intervention. This study found participants receiving the APA rehabilitation programme showed improvements in physical functioning, motivation, self-efficacy (a feeling that 'I can do' an action), pain and fatigue compared with the waitlist group. Based on these results, the authors conclude physical activity should be considered during the development of rehabilitation strategies for people with chronic disabilities.
Abstract
BACKGROUND Persons with chronic disabilities face a wide variety of problems with functioning that affect their level of physical activity and participation. We have limited knowledge about the effect of adapted physical activity (APA)-based rehabilitation on perceived mental and physical functioning. AIM: The main aim of this study was to evaluate the effect of APA‑based rehabilitation compared to waiting‑list on perceived mental and physical functioning. Secondly, we wanted to assess whether improvement in self‑efficacy, motivation, pain and fatigue during rehabilitation was related to the effect of the intervention. DESIGN Randomized controlled trial. SETTING In‑patient rehabilitation Center. POPULATION All subjects above 17 years who were referred by their physician to BHC between July 1, 2010 and August 1, 2012 without major cognitive or language problems were eligible for the study (N.=321). METHODS Persons above 17 years (men and women) with chronic disabilities who applied for a rehabilitation stay, were randomized to an adapted physical activity‑based rehabilitation intervention (N.=304) or waiting‑list with delayed rehabilitation. A total of 246 consented and were allocated to four week intervention or a waiting‑list control group. The main outcome was physical and mental functioning evaluated four weeks after rehabilitation using the Medical Outcomes Study 12-Item Short‑Form Health Survey (SF-12). RESULTS Compared to waiting‑list the adapted physical activity‑based intervention improved physical and mental functioning. Improvement in physical functioning during rehabilitation was related to reduced pain, improved motivation and self‑efficacy. CONCLUSIONS The results indicate that an adapted physical activity‑based rehabilitation program improves functioning. Improved efficacy for managing disability may mediate the improvement in mental functioning. CLINICAL REHABILITATION IMPACT Adapted physical activity‑based rehabilitation should be considered during the development of rehabilitation strategies for people with chronic disabilities. Motivational and self‑efficacy aspects must be addressed when organizing and evaluating rehabilitation programs.
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Effective nationwide school-based participatory extramural program on adolescent body mass index, health knowledge and behaviors.
Heo, M, Jimenez, CC, Lim, J, Isasi, CR, Blank, AE, Lounsbury, DW, Fredericks, L, Bouchard, M, Faith, MS, Wylie-Rosett, J
BMC pediatrics. 2018;18(1):7
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Adolescent obesity is a major public health concern that affects health status not only during adolescence but also during adulthood. The aim of this study was to test whether the HealthCorps program would improve weight status represented by body mass index (BMI; kg/m2) z-score and obesity class. A secondary aim was to identify knowledge and health behaviour domains that would be increased with the program. The study design was a two parallel arm quasi-experimental pre-post comparison design. A total of 2279 students from 62 schools participated in the HealthCorps program. Results indicate that HealthCorps program participation resulted in BMI z-score improvement among overweight/obese female students. Participation also resulted in increased knowledge in most domains regardless of sex and improved a few behaviour domains. However, it did not improve weight status among male students. Authors conclude that the HealthCorps was effective for BMI z-score improvements among female students in addition to significant positive effects on knowledge and a few behaviors in both sexes.
Abstract
BACKGROUND Adolescent obesity is a major public health concern. Open to all high school students regardless of weight status, HealthCorps is a nationwide program offering a comprehensive high school-based participatory educational program to indirectly address obesity. We tested a hypothesis that the HealthCorps program would decrease BMI z-scores among overweight or obese students, and reduce obesity rates, and evaluated its effects on health knowledge and behaviors. METHODS HealthCorps aimed to improve student knowledge and behaviors regarding nutrition quality, physical activity, sleep, breakfast intake, and mental resilience. Participating students received through HealthCorps coordinators weekly or bi-weekly classroom lessons either for a semester or a year in addition to various during- and after-school health-promoting activities and mentorship. Self-reported height and weight were collected along with questionnaires assessing knowledge and behaviors during 2013-2014 academic year among 14 HealthCorps-participating New York City high schools. This quasi experimental two-arm pre-post trial included 611 HealthCorps and 221 comparison arm students for the analytic sample. Sex-specific analyses stratified by weight status were adjusted for age and Hispanic ethnicity with clustering effects of schools and students taken into account. RESULTS HealthCorps female overweight/obese and obese student had a significant decrease in BMI z-scores (post-pre delta BMI z-score = -0.16 (95%CI = (-0.26, -0.05), p = 0.004 for the former; and = -0.23 (-0.44, -0.03), p = 0.028, for the latter) whereas comparison female counterparts did not. The HealthCorps students, but not the comparison students, had a significant increase for all knowledge domains except for the breakfast realm, and reported a greater number of significant behavior changes including fruit and vegetable intake and physical activities. CONCLUSIONS The HealthCorps program was associated with reduced BMI z-score in overweight/obese and obese female adolescents, with enhanced health knowledge and behavior for both sexes. With its wide reach, this may be a promising program to help combat adolescent obesity in schools. TRIAL REGISTRATION This study is registered as a clinical trial at the ClinicalTrials.gov registry with trial number NCT02277496 on September 10, 2014 (Retrospectively registered).
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Structured lifestyle education to support weight loss for people with schizophrenia, schizoaffective disorder and first episode psychosis: the STEPWISE RCT.
Holt, RI, Hind, D, Gossage-Worrall, R, Bradburn, MJ, Saxon, D, McCrone, P, Morris, TA, Etherington, A, Shiers, D, Barnard, K, et al
Health technology assessment (Winchester, England). 2018;22(65):1-160
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People with schizophrenia are often overweight. Losing weight and being more active can reduce the risk of type 2 diabetes mellitus, heart disease and dying early. The NHS recommends offering a weight loss programme; however, mental health care providers do not know the best way to do this. This study assessed whether an education programme to help people with psychosis to lose weight would be better than the usual care provided by the NHS. A total of 414 people took part. Half were selected at random to attend an education programme run by trained facilitators. The other half received their usual health care. The researchers found no difference in weight between the two groups, at either 3 months or 12 months. They also found that the programme did not provide good value for money. In interviews, service users said that they liked the education programme and that it helped them to eat healthily and lose weight. However, there was no change in their diet and activity levels in either group. Unfortunately, although some people benefited, the programme did not work for most people. The researchers concluded that they need to look for better ways to help people with psychosis to lose weight.
Abstract
BACKGROUND Obesity is twice as common in people with schizophrenia as in the general population. The National Institute for Health and Care Excellence guidance recommends that people with psychosis or schizophrenia, especially those taking antipsychotics, be offered a healthy eating and physical activity programme by their mental health care provider. There is insufficient evidence to inform how these lifestyle services should be commissioned. OBJECTIVES To develop a lifestyle intervention for people with first episode psychosis or schizophrenia and to evaluate its clinical effectiveness, cost-effectiveness, delivery and acceptability. DESIGN A two-arm, analyst-blind, parallel-group, randomised controlled trial, with a 1 : 1 allocation ratio, using web-based randomisation; a mixed-methods process evaluation, including qualitative case study methods and logic modelling; and a cost-utility analysis. SETTING Ten community mental health trusts in England. PARTICIPANTS People with first episode psychosis, schizophrenia or schizoaffective disorder. INTERVENTIONS Intervention group: (1) four 2.5-hour group-based structured lifestyle self-management education sessions, 1 week apart; (2) multimodal fortnightly support contacts; (3) three 2.5-hour group booster sessions at 3-monthly intervals, post core sessions. Control group: usual care assessed through a longitudinal survey. All participants received standard written lifestyle information. MAIN OUTCOME MEASURES The primary outcome was change in weight (kg) at 12 months post randomisation. The key secondary outcomes measured at 3 and 12 months included self-reported nutrition (measured with the Dietary Instrument for Nutrition Education questionnaire), objectively measured physical activity measured by accelerometry [GENEActiv (Activinsights, Kimbolton, UK)], biomedical measures, adverse events, patient-reported outcome measures and a health economic assessment. RESULTS The trial recruited 414 participants (intervention arm: 208 participants; usual care: 206 participants) between 10 March 2015 and 31 March 2016. A total of 341 participants (81.6%) completed the trial. A total of 412 participants were analysed. After 12 months, weight change did not differ between the groups (mean difference 0.0 kg, 95% confidence interval -1.59 to 1.67 kg; p = 0.964); physical activity, dietary intake and biochemical measures were unchanged. Glycated haemoglobin, fasting glucose and lipid profile were unchanged by the intervention. Quality of life, psychiatric symptoms and illness perception did not change during the trial. There were three deaths, but none was related to the intervention. Most adverse events were expected and related to the psychiatric illness. The process evaluation showed that the intervention was acceptable, with participants valuing the opportunity to interact with others facing similar challenges. Session feedback indicated that 87.2% of participants agreed that the sessions had met their needs. Some indicated the desire for more ongoing support. Professionals felt that the intervention was under-resourced and questioned the long-term sustainability within current NHS settings. Professionals would have preferred greater access to participants' behaviour data to tailor the intervention better. The incremental cost-effectiveness ratio from the health-care perspective is £246,921 per quality-adjusted life-year (QALY) gained and the incremental cost-effectiveness ratio from the societal perspective is £367,543 per QALY gained. CONCLUSIONS Despite the challenges of undertaking clinical research in this population, the trial successfully recruited and retained participants, indicating a high level of interest in weight management interventions; however, the STEPWISE intervention was neither clinically effective nor cost-effective. Further research will be required to define how overweight and obesity in people with schizophrenia should be managed. The trial results suggest that lifestyle programmes for people with schizophrenia may need greater resourcing than for other populations, and interventions that have been shown to be effective in other populations, such as people with diabetes mellitus, are not necessarily effective in people with schizophrenia. TRIAL REGISTRATION Current Controlled Trials ISRCTN19447796. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 65. See the NIHR Journals Library website for further project information.