A Randomized, Controlled, Supervised, Excerise Trial in Young Overweight Men and Women: The Midwest Exercise Trial II (MET2)

We evaluated weight loss response to 16 months of supervised exercise (45 minutes/d, 5 d/wk, 75% heart-rate-reserve) in sedentary, overweight/obese participants without energy restriction in the Midwest Exercise Trial (MET1). Results indicated men lost weight, women did not. The gender differences were associated with differences in the energy expenditure of exercise (EEEx) (men = 667 ± 116; women = 439 ± 88 kcal/session) when exercise was prescribed by frequency, intensity and duration. MET2 is a randomized control trial designed and powered to examine differences in weight loss and gender in response to EEEx for men and women of 400 or 600 kcal/session, 5d/wk, for 10 months without energy restriction. One hundred forty one participants will be randomized to 1 of 2 exercise groups or a non-exercise control. EEEx will be verified by indirect calorimetry monthly during the intervention. This study will evaluate: (1) the weight change response to two levels of EEEx versus non-exercise control; (2) gender differences in weight response to two levels of EEEx; (3) potential compensatory changes in energy intake and/or daily physical activity that may explain the observed weight changes. Results from this study may impact how exercise is prescribed for weight loss and prevention of weight regain and may clarify if men and women differ in response to exercise

Weight management by phone conference call: A comparision with a traditional face-to-face clinic. Rationale and design for a randomized equivalence trial

State-of-the-art treatment for weight management consists of a behavioral intervention to facilitate decreased energy intake and increased physical activity. These interventions are typically delivered face-to-face (FTF) by a health educator to a small group of participants. There are numerous barriers to participation in FTF clinics including availability, scheduling, the expense and time required to travel to the clinic site, and possible need for dependent care. Weight management clinics delivered by conference call have the potential to diminish or eliminate these barriers. The conference call approach may also reduce burden on providers, who could conduct clinic groups from almost any location without the expenses associated with maintaining FTF clinic space. A randomized trial will be conducted in 395 overweight/obese adults (BMI 25–39.9 kg/m2) to determine if weight loss (6 months) and weight maintenance (12 months) are equivalent between weight management interventions utilizing behavioral strategies and pre-packaged meals delivered by either a conference call or the traditional FTF approach. The primary outcome, body weight, will be assessed at baseline, 6, 12 and 18 months. Secondary outcomes including waist circumference, energy and macronutrient intake, and physical activity and will be assessed on the same schedule. In addition, a cost analysis and extensive process evaluation will be completed

The Midwest Exercise Trial for the Prevention of Weight Regain: MET POWeR

Weight reduction in overweight and obese individual’s results in physiological and behavioral changes that make the prevention of weight regain more difficult than either initial weight loss or the prevention of weight gain. Exercise is recommended for the prevention of weight regain by both governmental agencies and professional organizations. To date, the effectiveness of exercise recommendations for the prevention of weight regain has not been evaluated in a properly designed, adequately powered trial. Therefore, we will conduct a randomized trial to evaluate the effectiveness of 3 levels of exercise on the prevention of weight regain, in initially overweight and obese sedentary men and women. Participants will complete a 3 month weight loss intervention of decreased energy intake (EI) and increased exercise (100 minutes/week). Participants achieving clinically significant weight loss (≥ 5% of initial weight), will then be randomly assigned to 12 months of verified exercise at 3 levels (150, 225 or 300 minutes/week). This study will evaluate: 1) the effectiveness of 3 levels of exercise on the prevention of weight regain over 12 months subsequent to clinically significant weight loss (≥ 5%); 2) gender differences in weight regain in response to 3 levels of exercise; and 3) potential compensatory changes in daily physical activity (PA) and EI on weight regain in response to 3 levels of exercise. Results of this investigation will provide information to develop evidenced based recommendations for the level of exercise associated with the prevention of weight regain

Aerobic exercise alone results in clinically significant weight loss for men and women: Midwest Exercise Trial-2

This is the peer reviewed version of the following article: Donnelly, J. E., Honas, J. J., Smith, B. K., Mayo, M. S., Gibson, C. A., Sullivan, D. K., Lee, J., Herrmann, S. D., Lambourne, K. and Washburn, R. A. (2013), Aerobic exercise alone results in clinically significant weight loss for men and women: Midwest exercise trial 2. Obesity, 21: E219–E228. doi:10.1002/oby.20145, which has been published in final form at http://doi.org/10.1002/oby.20145. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.Exercise is recommended by public health agencies for weight management; however, the role of exercise is generally considered secondary to energy restriction. Few studies exist that have verified completion of exercise, measured the energy expenditure of exercise, and prescribed exercise with equivalent energy expenditure across individuals and genders. OBJECTIVE The objective of this study was to evaluate aerobic exercise, without energy restriction, on weight loss in sedentary overweight and obese men and women. DESIGN AND METHODS This investigation was a randomized, controlled, efficacy trial in 141 overweight and obese participants (body mass index, 31.0 ± 4.6 kg/m2; age 22.6 ± 3.9 years). Participants were randomized (2:2:1 ratio) to exercise at either 400 kcal/session or 600 kcal/session or to a non-exercise control. Exercise was supervised, 5 days/week, for 10 months. All participants were instructed to maintain usual ad libitum diets. Due to the efficacy design, completion of ≥ 90% of exercise sessions was an a priori definition of per protocol, and these participants were included in the analysis. RESULTS Weight loss from baseline to 10 months for the 400 and 600 kcal/session groups was 3.9 ± 4.9kg (4.3%) and 5.2 ± 5.6kg (5.7%), respectively compared to weight gain for controls of 0.5 ± 3.5kg (0.5%) (p<0.05). Differences for weight loss from baseline to 10 months between the exercise groups and differences between men and women within groups were not statistically significant. CONCLUSIONS Supervised exercise, with equivalent energy expenditure, results in clinically significant weight loss with no significant difference between men and women

Characterising the dynamics of cerebral metabolic dysfunction following traumatic brain injury: A microdialysis study in 619 patients.

Funder: National Institute for Health Research (NIHR)Traumatic brain injury (TBI) is a major cause of death and disability, particularly amongst young people. Current intensive care management of TBI patients is targeted at maintaining normal brain physiology and preventing secondary injury. Microdialysis is an invasive monitor that permits real-time assessment of derangements in cerebral metabolism and responses to treatment. We examined the prognostic value of microdialysis parameters, and the inter-relationships with other neuromonitoring modalities to identify interventions that improve metabolism. This was an analysis of prospective data in 619 adult TBI patients requiring intensive care treatment and invasive neuromonitoring at a tertiary UK neurosciences unit. Patients had continuous measurement of intracranial pressure (ICP), arterial blood pressure (ABP), brain tissue oxygenation (PbtO2), and cerebral metabolism and were managed according to a standardized therapeutic protocol. Microdialysate was assayed hourly for metabolites including glucose, pyruvate, and lactate. Cerebral perfusion pressure (CPP) and cerebral autoregulation (PRx) were derived from the ICP and ABP. Outcome was assessed with the Glasgow Outcome Score (GOS) at 6 months. Relationships between monitoring variables was examined with generalized additive mixed models (GAMM). Lactate/Pyruvate Ratio (LPR) over the first 3 to 7 days following injury was elevated amongst patients with poor outcome and was an independent predictor of ordinal GOS (p70mmHg, PRx 18mmHg, and brain glucose >1mM. Deranged cerebral metabolism is an important determinant of patient outcome following TBI. Variations in cerebral perfusion, oxygenation and glucose supply are associated with changes in cerebral LPR and suggest therapeutic interventions to improve cerebral metabolism. Future prospective studies are required to determine the efficacy of these strategies

Weight management for individuals with intellectual and developmental disabilities: Rationale and design for an 18 month randomized trial

Weight management for individuals with intellectual and developmental disabilities (IDD) has received limited attention. Studies on weight management in this population have been conducted over short time frames, in small samples with inadequate statistical power, infrequently used a randomized design, and have not evaluated the use of emerging effective dietary strategies such as pre-packaged meals (PMs). Low energy/fat PMs may be useful in individuals with IDD as they simplify meal planning, limit undesirable food choices, teach appropriate portion sizes, are convenient and easy to prepare, and when combined with fruits and vegetables provide a high volume, low energy dense meal. A randomized effectiveness trial will be conducted in 150 overweight/obese adults with mild to moderate IDD, and their study partners to compare weight loss (6 months) and weight maintenance (12 months) between 2 weight management approaches: 1. A Stop Light Diet enhanced with reduced energy/fat PMs (eSLD); and 2. A recommended care reduced energy/fat meal plan diet (RC). The primary aim is to compare weight loss (0–6 months) and weight maintenance (7–18 months) between the eSLD and RC diets. Secondarily, changes in chronic disease risk factors between the eSLD and RC diets including blood pressure, glucose, insulin, LDL-cholesterol, and HDL-cholesterol will be compared during both weight loss and weight maintenance. Finally, potential mediators of weight loss including energy intake, physical activity, data recording, adherence to the diet, study partner self-efficacy and daily stress related to dietary change will be explored

Effects of dairy intake on weight maintenance

Background: To compare the effects of low versus recommended levels of dairy intake on weight maintenance and body composition subsequent to weight loss. Design and Methods: Two site (University of Kansas-KU; University of Tennessee-UT), 9 month, randomized trial. Weight loss was baseline to 3 months, weight maintenance was 4 to 9 months. Participants were maintained randomly assigned to low dairy ( 3 servings/d) diets for the maintenance phase. Three hundred thirty eight men and women, age: 40.3 ± 7.0 years and BMI: 34.5 ± 3.1, were randomized; Change in weight and body composition (total fat, trunk fat) from 4 to 9 months were the primary outcomes. Blood chemistry, blood pressure, resting metabolism, and respiratory quotient were secondary outcomes. Energy intake, calcium intake, dairy intake, and physical activity were measured as process evaluation. Results: During weight maintenance, there were no overall significant differences for weight or body composition between the low and recommended dairy groups. A significant site interaction occurred with the low dairy group at KU maintaining weight and body composition and the low dairy group at UT increasing weight and body fat. The recommended dairy group exhibited reductions in plasma 1,25-(OH)2-D while no change was observed in the low dairy group. No other differences were found for blood chemistry, blood pressure or physical activity between low and recommended dairy groups. The recommended dairy group showed significantly greater energy intake and lower respiratory quotient compared to the low dairy group. Conclusion: Weight maintenance was similar for low and recommended dairy groups. The recommended dairy group exhibited evidence of greater fat oxidation and was able to consume greater energy without greater weight gain compared to the low dairy group. Recommended levels of dairy products may be used during weight maintenance without contributing to weight gain compared to diets low in dairy products. Trial Registration: ClinicalTrials.gov NCT0068642

Physical activity across the curriculum: year one process evaluation results

<p>Abstract</p> <p>Background</p> <p>Physical Activity Across the Curriculum (PAAC) is a 3-year elementary school-based intervention to determine if increased amounts of moderate intensity physical activity performed in the classroom will diminish gains in body mass index (BMI). It is a cluster-randomized, controlled trial, involving 4905 children (2505 intervention, 2400 control).</p> <p>Methods</p> <p>We collected both qualitative and quantitative process evaluation data from 24 schools (14 intervention and 10 control), which included tracking teacher training issues, challenges and barriers to effective implementation of PAAC lessons, initial and continual use of program specified activities, and potential competing factors, which might contaminate or lessen program effects.</p> <p>Results</p> <p>Overall teacher attendance at training sessions showed exceptional reach. Teachers incorporated active lessons on most days, resulting in significantly greater student physical activity levels compared to controls (p < 0.0001). Enjoyment ratings for classroom-based lessons were also higher for intervention students. Competing factors, which might influence program results, were not carried out at intervention or control schools or were judged to be minimal.</p> <p>Conclusion</p> <p>In the first year of the PAAC intervention, process evaluation results were instrumental in identifying successes and challenges faced by teachers when trying to modify existing academic lessons to incorporate physical activity.</p

Physical Activity Across the Curriculum (PAAC): a randomized controlled trial to promote physical activity and diminish overweight and obesity in elementary school children

Objective Physical Activity Across the Curriculum (PAAC) was a three-year cluster randomized controlled trial to promote physical activity and diminish increases in overweight and obesity in elementary school children. Methods Twenty-four elementary schools were cluster randomized to the PAAC intervention or served as control. All children in grades two and three were followed to grades four and five. PAAC promoted 90 minutes/wk of moderate to vigorous intensity physically active academic lessons delivered by classroom teachers. BMI was the primary outcome, daily PA and academic achievement were secondary outcomes. Results The three-year change in BMI for PAAC was 2.0 ± 1.9 and control 1.9 ± 1.9, respectively (NS). However, change in BMI from baseline to three years was significantly influenced by exposure to PAAC. Schools with ≥75 minutes of PAAC/wk showed significantly less increase in BMI at three years compared to schools that had <75 minutes of PAAC (1.8 ± 1.8 vs. 2.4 ± 2.0, p=0.02). PAAC schools had significantly greater changes in daily PA and academic achievement scores. Conclusions The PAAC approach may promote daily PA and academic achievement in elementary school children. Additionally, 75 minutes of PAAC activities may attenuate increases in BMI

Diverse Intestinal Bacteria Contain Putative Zwitterionic Capsular Polysaccharides with Anti-inflammatory Properties

Zwitterionic capsular polysaccharides (ZPSs) are bacterial products that modulate T cells, including inducing anti-inflammatory IL-10-secreting T regulatory cells (Tregs). However, only a few diverse bacteria are known to modulate the host immune system via ZPS. We present a genomic screen for bacteria encoding ZPS molecules. We identify diverse host-associated bacteria, including commensals and pathogens with known anti-inflammatory properties, with the capacity to produce ZPSs. Human mononuclear cells stimulated with lysates from putative ZPS-producing bacteria induce significantly greater IL-10 production and higher proportions of Tregs than lysates from non-ZPS-encoding relatives or a commensal strain of Bacteroides cellulosilyticus in which a putative ZPS biosynthetic operon was genetically disrupted. Similarly, wild-type B. cellulosilyticus DSM 14838, but not a close relative lacking a putative ZPS, attenuated experimental colitis in mice. Collectively, this screen identifies bacterial strains that may use ZPSs to interact with the host as well as those with potential probiotic properties