Effectiveness of a Medifast meal replacement program on weight, body composition and cardiometabolic risk factors in overweight and obese adults: a multicenter systematic retrospective chart review study.
ABSTRACT: BACKGROUND:Recent medical guidelines emphasize the importance of actively treating overweight and obesity with diet and lifestyle intervention to achieve ? 5% weight loss in a 6-month period. Commercial programs offer one approach provided there is evidence of their efficacy and safety. This study was conducted to evaluate the effectiveness of the Medifast® 4 & 2 & 1 Plan™ on weight loss, body composition and cardiometabolic risk factors in overweight and obese adults. METHODS:A systematic retrospective chart review of 310 overweight and obese clients following the Medifast 4 & 2 & 1 Plan at one of 21 Medifast Weight Control Centers® was conducted. Data were recorded electronically and key data points were independently verified. The primary endpoint was change from baseline body weight at 12 weeks. Within group paired t-tests were used to examine changes from baseline in a completers population. Differences between gender and age subgroups were examined using bivariate t-tests and mixed model regression analyses. RESULTS:For the primary endpoint at 12 weeks, body weight among completers (n = 185) was reduced by a mean of 10.9 ± 5.6 kg (-10.1%, p < 0.0001), and at 24 weeks (n = 81) mean weight was reduced by 16.0 ± 7.9 kg (-14.3%). At 12 and 24 weeks, 85% and 96% of those remaining on the plan, respectively, had lost ? 5% of their baseline body weight. Lean mass was preserved to within 5% of baseline throughout the 24 weeks, and fat mass represented ? 80% of the body weight lost from 12 weeks onward. Men, women, seniors (? 65 years), and non-seniors (<65 years) all had significant weight reductions with preservation of lean mass. Significant improvements in blood pressure, pulse and waist-to-hip ratio were observed. Mean weight regain among the subset who entered a formal maintenance phase was <2% during an average follow-up of 34 weeks. The meal plan was well tolerated, and program adherence was >85%. CONCLUSIONS:The 4 & 2 & 1 Plan used at Medifast Weight Control Centers was effective for weight loss, preservation of lean mass and improvement in cardiometabolic risk factors. The plan was generally well tolerated in a broad population of overweight and obese adults. #NCT02150837.
Project description:Abstract Weight loss among older adults remains controversial due to lean mass loss and potential exacerbation of disability risk. Using the Medifast for Seniors clinical trial (NCT02730988), which investigated high protein supplementation (?1.0 g/kg/d) during caloric restriction to preserve lean mass among 96 older adults (>70 years, 74% women, 27% black) with obesity (BMI: 35 kg/m^2), we applied untargeted metabolomics to identify small molecules associated with the highly variable change in lean muscle mass during weight loss. Forty-seven participants were randomized to high protein weight loss, and 92% lost at least 5% body weight over 24 weeks. Across DXA-ascertained measures of lean body mass, gynoid lean mass exhibited the broadest range of change: +4% to -12%. For 38 participants, untargeted metabolomics data was generated from fasted serum samples collected before and after intervention. 121 serum metabolites were identified and change from baseline was tested for correlation with percent change in gynoid muscle mass. Increasing nicotinamide levels were associated with a greater loss of gynoid muscle mass (R^2=0.22, p=0.0027). Pathway analysis was applied to identify Kyoto Encyclopedia of Genes and Genomes (KEGG) biochemical pathways containing multiple nominally-associated metabolites. The amino sugar and nucleotide sugar metabolism pathway was significantly enriched (p=0.006), containing four sugar metabolites associated with shifts in lean muscle mass. This pathway is important in the glycosylation of polysaccharides, a ubiquitous and important regulator of energy metabolism, but has not previously been linked to muscle mass and should be further interrogated in preservation of lean muscle during weight loss.
Project description:Objective:Lifestyle interventions remain the cornerstone for obesity treatment. Commercial programs offer one weight loss approach, yet the efficacy of few such programs have been rigorously investigated. The purpose of this study was to evaluate the efficacy of two commercial weight-loss programs, both utilizing pre-portioned meal replacements (MRs) and different levels of behavioural support, compared to a self-directed control diet in adults with overweight and obesity. Methods:In this 16-week study, participants were randomized to the low-calorie OPTAVIA® 5&1 Plan® with telephone coaching (OPT), the reduced-calorie Medifast® 4&2&1 self-guided plan (MED), or a self-directed, reduced-calorie control diet. Differences in weight, body composition (DXA) and body circumferences, all measured monthly, were assessed by analysis of covariance with sex and baseline measures as covariates. Results:Of 198 participants randomized (80.8% female, BMI 34.2 kg/m2, 45.7 years), 92.3% completed the study. The OPT and MED groups had significantly greater reductions in body weight (-5.7% and - 5.0%, respectively, p < 0.0001), fat and abdominal fat mass (p < 0.0001) and waist and hip circumferences (p ? 0.003) than control at 16 weeks. Weight change was correlated with MR usage and completion of coaching support calls. Conclusions:Both structured commercial programs were more efficacious than a self-directed, reduced-calorie diet for weight loss and other anthropometric measures. Evidence-based commercial programs can be an important tool to help adults with overweight and obesity lose clinically relevant amounts of weight.
Project description:The Medifast 5 & 1 Plan (MD) is a portion-controlled, nutritionally-balanced, low-fat weight-loss plan. We studied the effects of MD compared with a reduced-energy, food-based diet (FB) on body weight, waist circumference, fat mass and other measures in adults.We conducted a two-parallel-arm, randomized, controlled trial comparing MD to FB over 52 weeks. A total of 120 men and women aged 19-65 years with BMI ?35 and ?50?kg?m(-2) were randomized to MD (n=60) or FB (n=60). Follow-up included a 26-week weight-loss phase and 26-week weight-maintenance phase. Anthropometric, body composition, biochemical and appetite/satiety measures were performed at baseline and at 26 and 52 weeks. An intention-to-treat, linear mixed models analysis was the primary analysis.Fifty MD subjects (83.3%) and 45 FB subjects (75.0%) completed the study on assigned treatment. At 26 weeks, race-adjusted mean weight loss was 7.5?kg in MD subjects vs 3.8?kg in FB subjects (P=0.0002 for difference); reduction in waist circumference was 5.7?cm in MD vs 3.7?cm in FB (P=0.0064); and fat mass loss was 6.4?kg in MD vs 3.7?kg in FB (P=0.0011). At 52 weeks, the corresponding reductions were 4.7 vs 1.9?kg (P=0.0004); 5.0 vs 3.6?cm (P=0.0082); and 4.1 vs 1.9?kg (P=0.0019) in MD and FB subjects, respectively.In obese adults, MD resulted in significantly greater reductions in body weight and fat compared with an FB diet for 1 year after randomization.
Project description:BACKGROUND:Obesity has reached epidemic proportions in the United States. It is implicated in the development of a variety of chronic disease states and is associated with increased levels of inflammation and oxidative stress. The objective of this study is to examine the effect of Medifast's meal replacement program (MD) on body weight, body composition, and biomarkers of inflammation and oxidative stress among obese individuals following a period of weight loss and weight maintenance compared to a an isocaloric, food-based diet (FB). METHODS:This 40-week randomized, controlled clinical trial included 90 obese adults with a body mass index (BMI) between 30 and 50 kg/m2, randomly assigned to one of two weight loss programs for 16 weeks and then followed for a 24-week period of weight maintenance. The dietary interventions consisted of Medifast's meal replacement program for weight loss and weight maintenance, or a self-selected, isocaloric, food-based meal plan. RESULTS:Weight loss at 16 weeks was significantly better in the Medifast group (MD) versus the food-based group (FB) (12.3% vs. 6.9%), and while significantly more weight was regained during weight maintenance on MD versus FB, overall greater weight loss was achieved on MD versus FB. Significantly more of the MD participants lost >or= 5% of their initial weight at week 16 (93% vs. 55%) and week 40 (62% vs. 30%). There was no difference in satiety observed between the two groups during the weight loss phase. Significant improvements in body composition were also observed in MD participants compared to FB at week 16 and week 40. At week 40, both groups experienced improvements in biochemical outcomes and other clinical indicators. CONCLUSIONS:Our data suggest that the meal replacement diet plan evaluated was an effective strategy for producing robust initial weight loss and for achieving improvements in a number of health-related parameters during weight maintenance, including inflammation and oxidative stress, two key factors more recently shown to underlie our most common chronic diseases. TRIAL REGISTRATION:ClinicalTrials.gov NCT01011491.
Project description:Background:Weight loss, especially fat mass reduction, helps to improve blood glucose control, insulin sensitivity, and ?-cell function. This study aimed to compare the effect of exenatide and glargine on body composition in overweight and obese patients with type 2 diabetes (T2DM) who do not achieve adequate glycemic control with metformin. Methods:We performed a prospective, randomized study of 37 overweight or obese patients with T2DM who had inadequate glycemic control with metformin. The patients were treated with either exenatide or glargine for 16 weeks. Dual-energy X-ray absorptiometry was used to assess body composition. Results:Post-intervention weight, body mass index (BMI), waist circumference, body mass, and fat mass were lower in patients treated with exenatide, while weight and BMI significantly increased with glargine. Reductions in weight, BMI, body fat mass, and percent fat mass (except for gynoid) were greater with exenatide than with glargine, and percent lean tissue (other than the limbs) increased with exenatide. In all body regions except for the limbs, fat mass decreased with exenatide to a greater extent than lean tissue. Glucose control, insulin resistance, and ?-cell function were not different between the treatment groups. Conclusions:For overweight and obese patients whose T2DM was inadequately controlled with metformin, exenatide and glargine achieved similar improvements in glycemic control, insulin sensitivity, and ?-cell function.However, exenatide produced better weight and fat mass reduction, which were beneficial for blood glucose control. Our findings may guide the selection of appropriate drugs for glycemic and weight control. Trial registration:NCT02325960, registered 25 December 2014.
Project description:<h4>Purpose</h4>Obesity during adolescence has multisystem health consequences. The objective of this work was to determine whether preadolescent overweight/obese children's bones respond to a 9-month physical activity intervention by increasing bone density similar to healthy weight children.<h4>Methods</h4>Participants included overweight/obese (BMI > 85%) and healthy weight (15% < BMI < 85%) preadolescents (8-9 yr old). Participants in the physical activity group participated in a 9-month physical activity curriculum every day after school. The wait list control group received no intervention. Both groups had overweight/obese children and healthy weight controls. Whole-body bone mineral content, area, and bone mineral apparent density (BMAD) were assessed using dual x-ray absorptiometry) at the beginning and end of the 9-month trial in the physical activity and control group.<h4>Results</h4>Overweight/obese preadolescent children had higher BMAD than healthy weight children (P < 0.001 for spine, leg, and whole body). However, the density/weight (BMAD/lean mass) was lower in overweight/obese children than that in healthy weight children, indicating that the density of bones in overweight/obese children may not compensate sufficiently for the excessive load due to weight. The change in BMAD over 9 months was greater in healthy weight children than overweight/obese children in the whole body and leg, but not the lumbar spine. Physical activity caused a site-specific increase in bone density, affecting the legs more than the lumbar spine, but there was no significant difference in the effect of exercise between the healthy weight and the overweight/obese group.<h4>Conclusions</h4>The smaller change in BMAD over the 9 months and lower BMAD per unit lean mass in overweight/obese compared with healthy weight children may indicate a slower rate of bone mass accrual, which may have implications for bone health during skeletal growth in obese/overweight children.
Project description:The 'obesity paradox' of critical illness refers to better survival with a higher body mass index. We hypothesized that fat mobilized from excess adipose tissue during critical illness provides energy more efficiently than exogenous macronutrients and could prevent lean tissue wasting.In lean and premorbidly obese mice, the effect of 5?days of sepsis-induced critical illness on body weight and composition, muscle wasting, and weakness was assessed, each with fasting and parenteral feeding. Also, in lean and overweight/obese prolonged critically ill patients, markers of muscle wasting and weakness were compared.In mice, sepsis reduced body weight similarly in the lean and obese, but in the obese with more fat loss and less loss of muscle mass, better preservation of myofibre size and muscle force, and less loss of ectopic lipids, irrespective of administered feeding. These differences between lean and obese septic mice coincided with signs of more effective hepatic fatty acid and glycerol metabolism, and ketogenesis in the obese. Also in humans, better preservation of myofibre size and muscle strength was observed in overweight/obese compared with lean prolonged critically ill patients.During critical illness premorbid obesity, but not nutrition, optimized utilization of stored lipids and attenuated muscle wasting and weakness.
Project description:Past studies of asthma in overweight/obese children have been inconsistent. The reason overweight/obese children commonly report worse asthma control remains unclear.To determine qualitative differences in symptoms between lean and overweight/obese children with early-onset, atopic asthma.We conducted a cross-sectional analytic study of lean (20% to 65% body mass index) and overweight/obese (?85% body mass index) 10- to 17-year-old children with persistent, early-onset asthma. Participants completed 2 to 3 visits to provide a complete history, qualitative and quantitative asthma symptom characterization, and lung function testing. We determined associations between weight status and symptoms using multivariable linear and logistic regression methods.Overweight/obese and lean asthmatic children displayed similar lung function. Despite lower fraction of exhaled nitric oxide (30.0 vs 62.6 ppb; P = .037) and reduced methacholine responsiveness (PC20FEV1 1.87 vs 0.45 mg/mL; P < .012), overweight/obese children reported more than thrice frequent rescue treatments (3.7 vs 1.1 treatments/wk; P = .0002) than did lean children. Weight status affected the child's primary symptom reported with loss of asthma control (Fisher exact test; P = .003); overweight/obese children more often reported shortness of breath (odds ratio = 11.8; 95% CI, 1.41-98.7) and less often reported cough (odds ratio = 0.26; 95% CI, 0.08-0.82). Gastroesophageal reflux scores were higher in overweight/obese children (9.6 vs 23.2; P = .003) and appear to mediate overweight/obesity-related asthma symptoms.Overweight/obese children with early-onset asthma display poorer asthma control and a distinct pattern of symptoms. Greater shortness of breath and ?-agonist use appears to be partially mediated via esophageal reflux symptoms. Overweight children with asthma may falsely attribute exertional dyspnea and esophageal reflux to asthma, leading to excess rescue medication use.
Project description:The total body weight-based dosing strategy currently used in the prophylactic treatment of hemophilia A may not be appropriate for all populations. The assumptions that guide weight-based dosing are not valid in overweight and obese populations, resulting in overdosing and ineffective resource utilization. We explored different weight metrics including lean body weight, ideal body weight, and adjusted body weight to determine an alternative dosing strategy that is both safe and resource-efficient in normal and overweight/obese adult patients. Using a validated population pharmacokinetic model, we simulated a variety of dosing regimens using different doses, weight metrics, and frequencies; we also investigated the implications of assuming various levels of endogenous factor production. Ideal body weight performed the best across all of the regimens explored, maintaining safety while moderating resource consumption for overweight and obese patients.
Project description:Weight gain in pregnancy is an essential physiologic adaptation that supports growth and development of a fetus and is distributed among lean mass that includes total body water and fat mass gains. Although gestational weight gain provides a source of energy for the mother and fetus, excess gestational weight gain may underlie reported associations between parity and future metabolic disorders and is linked to postpartum weight retention and insulin resistance. Although weight gain often is proposed as a modifiable variable to mitigate adverse maternal and offspring health outcomes, our knowledge of specific maternal body composition changes with weight gain and the potential metabolic consequences is limited. Furthermore, although gestational weight gain alters maternal body composition, the impact of excess weight gain on fat and lean mass is not well-studied. Understanding the accrual of fat and lean body mass may improve our understanding of the role of excessive gestational weight gain and metabolic dysfunction.The purpose of our study was to quantify the relationship between gestational weight gain and maternal fat and lean body mass accrual and to compare fat and lean body mass accrual according to the 2009 Institute of Medicine Guidelines for Gestational Weight Gain in Pregnancy adherence. We hypothesized that exceeding current weight gain guidelines would be associated with greater fat, compared with lean body, mass accrual.This is a secondary analysis of a randomized controlled trial of 49 overweight/obese women; all 49 are included in this secondary analysis. Maternal weight and body composition were collected in early (13 0/6 to 16 6/7 weeks gestation) and late (34 0/7 to 36 6/7 weeks gestation) pregnancy with the use of air densitometry. Correlations were drawn between gestational weight gain and change in fat and lean body mass. We compared change in fat and lean body mass by adherence to the 2009 Institute of Medicine Guidelines for Gestational Weight Gain in Pregnancy. Nonparametric tests and chi-square analyses were performed; a probability value of <.05 was significant.Early pregnancy body mass index was 30.3 kg/m(2) (interquartile range [IQR], 28.5-35.2 kg/m(2)); women gained 9.0 kg (IQR, 5.3-13.2 kg). Overweight and obese women were equally likely to gain excess weight (48% vs 35%; P = .6). Weight gain correlated strongly with fat mass change (r = 0.87; P < .001); women with excess vs adequate vs inadequate weight gain had greater fat mass change overall (5.2 [IQR, 4.2-8.1] vs 0.2 [IQR, -0.4-2.2] vs -2.7 [IQR, -5.2- -0.7] kg, respectively; P < .001) and in all pairwise comparisons. Weight gain also correlated with lean body mass change (r = 0.52; P = .001), but women with excess vs adequate weight gain had similar lean body mass change (8.4 [IQR, 7.2-10.1] vs 7.8 [IQR, 6.0-8.7] kg; P = .1).Excess gestational weight gain is associated primarily with maternal fat, but not with lean body mass accrual. Our results may help explain the reason that excess gestational weight gain or fat mass accrual is associated with long-term obesity, metabolic dysfunction, and cardiovascular disease risk.