Dieters on Medifast do typically lose weight, especially in the beginning. The diet calls for only to 1, calories to be ingested on a daily basis. However, the level of weight loss success ultimately depends on the ability of a participant to stick to all the rules set forth by Medifast. Even though weight loss can be expected by those following the diet program to a tee, the amount of weight loss is greatly contested. I think the results are overstated in a lot of the publicity and that was the biggest drawback for me.

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Commercial programs offer one approach provided there is evidence of their efficacy and safety. Data were recorded electronically and key data points were independently verified. 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. Significant improvements in blood pressure, pulse and waist-to-hip ratio were observed. The plan was generally well tolerated in a broad population of overweight and obese adults. The online version of this article doi Overweight and obesity are linked to a multitude of serious comorbidities, and obesity carries an additional risk of greater all-cause and cardiovascular disease mortality [ 1 ].

While recent trends seem to indicate that overall increases in the prevalence of obesity may be leveling off, the rates of obesity in men significantly increased between and , and the age-adjusted rates indicate women aged 60 and older have the highest rates of obesity at Unfortunately, there is a paucity of research in both men and older adults as most existing weight loss intervention studies have under-represented or excluded these populations [ 6 , 7 ].

For overweight or obese individuals, even a relatively small amount of weight loss can reduce the risk of developing related co-morbidities, such as cardiovascular disease, type 2 diabetes and some forms of cancers [ 1 , 8 — 11 ]. Commercial programs that provide a comprehensive lifestyle intervention are also supported as an option for weight loss within these guidelines, provided they are backed by evidence of their safety and efficacy.

Additionally, evidence also supports the use of meal replacements as part of a structured approach to obesity treatment, as meal replacements have been shown to be a safe and effective tool for limiting calorie intake and promoting weight loss and weight maintenance among overweight and obese individuals [ 14 , 15 ]. Secondary objectives included assessing effects of this plan on body composition and cardiometabolic risk factors.

Once identified, charts were pre-screened at each MWCC for the presence of a signed personal health information PHI consent form which included permission to use their data for research purposes , and then shipped to corporate headquarters for formal screening and data abstraction.

The study was approved by an independent institutional review board Western Institutional Review Board, Puyallup, WA which concluded that the study met the requirements for a waiver from the informed consent process per 45 CFR This study adhered to current methodological standards for retrospective chart reviews [ 19 ] and was registered in the ClinicalTrials.

The weight management program offered at the MWCC consists of weekly one-on-one in-person sessions with MWCC counselors who utilize motivational interviewing and a series of personalized behavior change strategies designed to develop behaviors that promote long-term weight management through a healthy lifestyle.

MWCC counselors are trained using a combination of on-the-job and corporate-based training to ensure thorough knowledge of the Medifast products and programs and an understanding of the behavior change strategies used at MWCC.

Programs generally include active Weight Loss, Transition, and Maintenance phases. Following the Weight Loss phase, some MWCCs may include a Transition phase, during which calorie intake and conventional food choices are gradually increased.

All individuals who meet their weight loss goal or who have completed their prescribed weight loss weeks then have the option to enter the Maintenance phase. Data were recorded in client charts at MWCCs by counselors. Counselors were trained to use consistent procedures when obtaining weights and anthropometric measurements.

Weight was measured to the nearest 0. Blood pressure and pulse were measured using digital arm blood pressure monitors. This information was reviewed and categorized by a registered nurse, and simple frequencies were tabulated.

Chart data were abstracted by trained study personnel directly into electronic case report forms developed using IBM SPSS Data Collection Author and Interviewer Version 7, according to conventions developed for this study. A two-user, independent double-data data entry procedure was used for verification of all key data points. Data were analyzed according to a pre-defined statistical analysis plan.

Normality testing was performed. Wilcoxon signed rank tests i. When appropriate, results from parametric and non-parametric tests were performed to ensure they provided similar findings. Similar analyses were conducted on secondary outcomes. An intention-to-treat ITT last observation carried forward LOCF analysis, pre-specified in the protocol, was also performed for the primary outcome for comparison.

Additionally, in order to maximize the use of all data, including those with missing data, a pre-specified mixed model regression approach was used on the primary outcome, weight, with time as the independent variable and baseline weight as a covariate.

Weight results were converted from lbs to kg and circumference measurements were converted from inches to cm. Differences between groups were examined using bivariate t-tests as well as mixed model regression analyses.

Of the charts received for screening, met the study entry criteria and were included in the study. Flow diagram. Chart disposition at week 12 primary endpoint , week 24 and Final Visit. The Completers population included all individuals that had weight data within the specified visit window.

The group was comprised of The mean age was Percent change from baseline body weight. Absolute weight changes in kg are shown below the graph. In the completers analysis, half Analysis of the Completers population which included all individuals with weight data at the given visit; sample sizes are designated below the graph. Fat mass was ultimately reduced by Change from baseline body weight, lean body mass and body fat mass. Weight loss was first examined by gender.

The mean baseline body weight of females This finding was confirmed by a random effects regression model, controlling for baseline weight and time, which showed a main effect of gender: males lost on average 1.

Body composition was also examined by gender. Both males and females had considerable reductions from baseline in body fat mass Similarly, in absolute terms, with the exception of weeks 16 and 24, males lost significantly more fat mass, and other than week 12, not more lean mass than females Additional file 5. Percent change from baseline in a body weight and b lean and fat mass by gender. In a random effects regression model, controlling for baseline weight and time, there was not a main effect of age i.

Percent change from baseline a body weight and b lean and fat mass by age group. Completers included all individuals with weight data at the given visit; sample sizes are designated below the graph.

Body composition was also examined by age group. Percent changes from baseline in both lean and fat mass were similar between groups, with only small, sporadic differences noted Fig. Average reductions in blood pressure were Heart rates decreased, on average, by 3.

When examined with bivariate analyses comparing adherent and non-adherent groups, no relationship was found between attendance at weekly MWCC counseling sessions and weight loss on this plan. During this time, they lost, on average, an additional 2.

Despite this regain, the weight of these individuals remained Signs, symptoms and incidents notated in the charts represented lay accounts, and their descriptions were typically quite general in nature; relatedness and severity often could not be assessed from the information provided. This latter term was too general to categorize or assess further.

High blood pressure not necessarily worsening was noted in 6. There were 9 reports 2. The ruptured hemorrhoid was secondary to constipation.

Four of clients 1. The use of portion-controlled meal replacements as a part of a structured meal plan has been shown to be a safe and effective method for increasing dietary compliance and providing clinically meaningful, sustainable weight loss and improvements in weight-related disease risk factors [ 14 , 16 , 17 , 21 — 23 ].

MWCC weight loss programs include weekly visits with behavioral counseling. Similar to other studies, after controlling for baseline weight, men lost more weight than women in both age categories [ 24 ]. One explanation may be the set calorie level provided by the plan, which would generally represent a greater caloric deficit for men who, as a group, weighed more than women at baseline.

Although some loss of lean mass is always expected during weight loss [ 26 ], minimizing lean mass loss is an important health and safety consideration in order to maintain strength and physical function and also to maximize basal metabolic rate for long term weight maintenance. Although the changes in the proportion of lean to total body weight during energy deficit can vary considerably depending on many factors e.

This program fared well against these estimates. While increases in activity were encouraged, the program did not include a structured exercise regimen; therefore, the nutritional composition of this meal plan is likely an important contributing factor in the retention of lean mass.

Recent research suggests protein intake in the range of at least 1. Conservation of lean mass is a particularly important safety consideration in seniors due to naturally-occurring sarcopenia and concerns over loss of muscle mass and possible concomitant loss in physical function [ 7 ].

For this reason, body composition between seniors and non-seniors was compared. To account for the fact that the non-seniors group weighed more at baseline, lean and fat masses were examined as a percentage of their respective baseline values. This analysis showed seniors and non-seniors had nearly identical changes in lean and fat mass. Indeed, a recent week pilot study in older adults who used four Medifast Meal Replacements daily reported 7. Body composition was also examined by gender as previous reports have suggested that changes in body composition during energy deficit may be gender specific [ 27 , 34 ].

Males lost significantly more fat mass absolute and as a proportion of baseline fat mass but similar absolute and proportional lean mass compared to females.

An important medical goal of intentional weight loss is to reduce cardiovascular risk factors. Adherence is generally a key factor in weight loss success [ 36 , 37 ]. Results from previous studies have shown that the use of highly structured meal plans [ 38 , 39 ], consumption of portion-controlled meal replacements [ 14 , 21 , 23 , 36 ], and support session attendance [ 16 , 36 , 37 ] may promote greater adherence and are all positively associated with improved weight loss outcomes.

In this study, program adherence was assessed based on self-reported consumption of meal replacements and by attendance at weekly visits. Adherence to meal replacement consumption was positively related to weight loss, whereas an association with visit attendance was not detected in this study. Despite differences in data collection and analysis methods, meal replacement adherence was significantly associated with weight loss in both studies, reinforcing the importance of this factor to weight loss success on these programs.

The higher overall rate of attendance adherence in the current study may have made an association more difficult to detect than in the previous study. To address the concern of missing data, data for the primary outcome were analyzed by three different methods completers, ITT LOCF and mixed model regression analyses ; all methods provided consistent results.

Another observation in this study was the relatively large variability in responses. This is similar to other retrospective weight loss studies [ 16 , 40 ] and likely reflects the fact that the study included real customers who were not following a defined study protocol.


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