To the Editor: The randomized trial by Dr Goodpaster and colleagues1 demonstrated a significant improvement in weight and cardiovascular risk in severely obese subjects who underwent a 1-year intensive lifestyle intervention consisting of diet and physical activity.
Randomized clinical trials are often the best approach to study the effect of therapeutic interventions. However, selection of the population for a trial involves excluding a variable proportion of patients, which can make it difficult to translate the results into clinical practice. This is particularly the case when dealing with a behavioral intervention.
For this study, 595 participants were considered eligible, but only 130 (21.8%) were eventually randomized. One group of 190 patients was excluded “after a brief explanation of study and initial assessment of eligibility.” This requires further explanation. Were they not severely obese? If they were, why did they not participate? A second group of 178 candidates was excluded because they “did not attend” or were “not interested.” These are patients for whom intervention might be beneficial but who might be harder to motivate. Finally, another group of 97 patients was also excluded for issues such as withdrawal, adherence issues, diabetes, and hypertension. These exclusions are a concern because obesity is a cause of social disparities, and an unfavorable social environment is a potential contributor to the development of obesity.2 - 4 Participants who are more predisposed to become obese may also be less inclined to attend a trial.
In our uncontrolled case series published in 2008,5 we documented a 1.3-point reduction in body mass index (calculated as weight in kilograms divided by height in meters squared) in the short term, and after a median of 358 days, only 21% of the patients who were studied continued to lose weight. The results are similar to those of Goodpaster et al1 in a different population. Despite this, we think that the authors should be more cautious in their conclusions since their results apply to a selected minority of the potentially eligible population.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
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