Once upon a time, some pundit declared that, in the real estate business, the three most important factors are location, location, and location. That witticism became a meme in the original sense — not a word and picture combo for the Internet, but a mental construct that catches on because of its infinite adaptability. This explains why, about a hundred years later, academics were inspired to title an article “The Secrets of a Successful Clinical Trial: Compliance, Compliance, and Compliance.”
Let it be understood that the authors are talking about drug trials. This is not an exact parallel to child obesity studies. But human nature has a way of being impressively consistent across disciplines, so there may be something here to learn. The report says:
The extent to which patient noncompliance has marred clinical research has in some cases been underestimated, and one step to improving the design of clinical trials may lie in better attempts to analyze patient compliance during drug testing and clinical development.
In drug trials, the earliest basic decisions, such as, “Should we proceed with this, or not?,” are determined inside the controlled boundaries of the laboratory. But this omniscient degree of oversight must eventually end. As the authors put it:
In contrast, once a compound has progressed to efficacy trials, both economic and logistic considerations most often dictate that studies will be done in an outpatient population.
This delineation might be roughly compared to the difference between an immersive, residential, inpatient weight-loss program, and the unsurveilled life of an obese person in the wild. In the laboratory or at the “fat farm,” the time duration of the intensely observed stage of the study is predefined.
Transition from the lab or the institution to the real world is a major parameter shift. Now, the person must deal with the prospect of an extended time period, or even an open-ended one, and psychologically that makes quite a difference.
For that and other reasons, adjustments need to be made in attitude and behavior if the experiment is to go well. Also, it is worth ascertaining whether the subject unconsciously doesn’t care if the experiment goes well or not.
Similarities between drug trials and obesity studies
The authors point out that pharmaceutical trials tend to attract “professional subjects,” which may describe college students trying to make ends meet, but is unlikely to be true of kids trying to end their obesity. The authors qualify this by adding that the untrustworthiness factor arises particularly…
[…] when entry criteria and endpoints are “soft,” such as trials using subjective rating scales which can be “gamed.”
Now the situation sounds more familiar to the child obesity prevention community. Because weight loss is a gradual, long-term process, and because of the impossibility of monitoring subjects 24/7, much information is gathered via self-reporting, which cannot help but be unreliable.
The system, in other words, can definitely be gamed. The challenge in both cases is to convince the participants not to. Subjects in the outpatient phase of a drug trial, and participants in Dr. Pretlow’s W8Loss2Go program share a very important similarity: the absolute necessity of personal integrity, responsibility and accountability.
Your responses and feedback are welcome!
Source: “The Secrets of a Successful Clinical Trial: Compliance, Compliance, and Compliance,” NIH.gov, April 2011
Photo credit: marvelousRoland on Visualhunt/CC BY-SA
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