IT HAPPENED TO ME: I'm Part of a Clinical Trial for a Weight Loss Device

It's been an emotionally tense and introspective experience.
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Publish date:
June 5, 2015
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Tags:
weight loss, body image, mental health, Calorie Control, Weight Loss Study

I’m sitting blindfolded in the radiology department at my local hospital trying to work up the courage to swallow a pill about half the size of my thumb.

A small voice tells me to go for it whenever I’m ready. That sentiment is echoed by the voice of the supervising physician. My throat is tight and I’m having trouble readying myself for the year to come.

Maybe if I could see the pill this would be easier, but if I do, I forfeit my place in the study. As part of the controls of the weight loss study, if I remove the blindfold to see whether or not I have the placebo or am gifted with the weight loss device, I’m automatically dropped from the study. My hands move to the blindfold anyway as the physician reminds me gently that I’m doing this for my health.

Whether you believe in BMI as an adequate measure for health, by its definition I’m obese. When I say it, the weight of past scolding medical professionals falls around me in a way that feels more concrete than Chicken Little and the sky.

I was once told by my primary care physician that fat was inherently bad, despite no other poor health markers because it puts too much strain on your organ systems. The summation of his argument: If you are fat you are in poor health. That is final.

I wanted to ask him about my grandparents, who were both obese in their wedding photo but are still alive today without any of the co-morbidities associated with obesity. But I couldn't find the words. Of course they have aches, pains and other health issues, but what 80-plus-year-old doesn’t? He wouldn’t have had time for my anecdotal evidence anyway.

Joining the weight loss study was as simple as hearing an ad on the radio asking if I was obese. It came on a day, like many before it, that I couldn’t handle being fat anymore. I’d just gotten out of a boxing lesson and was upset that my body doesn’t look like I box. It feels like I owe it to society to be attractive and just can’t deliver. I’m not pretty but I always thought that if I could be thin, I could get away with it.

There was a time that I subscribed to HAES, but felt like I was an impostor because although I could see myself as healthy, I couldn’t understand why vegetables and exercise weren’t helping me lose weight.

For whatever reason, maybe a lack of confidence, or maybe societal pressure, I really just want to be thin. I’ve never gotten there even when I committed to sessions with various weight loss groups. From Overeaters Anonymous to Weight Watchers to Jenny Craig – you name it, I went to that meeting. You name that fitness craze; I participated in it. But I’ve remained obese.

A woman identifying herself as part of the bariatric department answered when I called the number in the radio ad. She asked a series of vague questions about my health, my height and weight, and whether or not I’ve had stomach surgery and if I was scheduled for or considering any surgical weight loss procedures.

Despite having health insurance, weight loss surgery was cost prohibitive. I met the criteria to begin preliminary medical testing for the weight loss study.

They call it the "Balloon Trial." It is a year-long medical research study wherein you swallow a pill tethered to a tiny catheter. That is then inflated with gas to 250ccs and there the balloon bobs precariously in your stomach mimicking the feeling of fullness and thus ensuring you eat less. You can have up to three inserted for a period of up to six months. 750ccs floating around in your stomach. Throughout the course of the study, the amount of balloons you receive depends on how quickly you are losing weight.

While the device is in a testing phase here in the U.S., the apparatus is currently approved for use in some European countries. Side effects include but are not limited to nausea, vomiting, ulcers, balloon deflation and the balloon getting lodged in your intestines. Yet, I was still willing to give it a try as a last ditch effort as I tried to save for surgery.

Step two was a little more invasive than a questionnaire. I was asked to set aside some time for a slew of medical procedures. In order to determine eligibility, I was subject to a brief mental health questionnaire, an EKG, an upper GI with contrast, h. pylori test and blood work.

By far, the least pleasant procedure was the upper GI. You have to hold barium (re: radioactive) contrast in your mouth and swallow when told to by the radiologist. They X-ray the contrast as it moves to your stomach. While fascinating to watch, contrast tastes like expired Pepto-Bismol with the consistency of runny cake batter.

Once all of the physical exams were out of the way and I was given a clean bill of health, it was time for study-specific nutritional counseling.

Once formally accepted into the study, this would occur every three weeks for a year. Six months with the balloon and six months to maintain weight loss. Should I have the placebo, and am still obese after the first six months, I can choose to take the balloon.

The initial nutritionist meeting was tense for me. I’d never examined my eating habits in such a way. Since I’d practiced intuitive eating in the past, I had minimal knowledge of how many calories I took in on a daily basis. I simply ate when I was hungry, stopped when I was full, and gave into a few too many cravings.

The nutritionist asked a series of questions including what I ate for breakfast, lunch, and dinner. If and how much I exercised and approximate meal times. Two roadblocks in my quest to weight loss were not eating breakfast and eating dinner after 9 p.m.

I explained to the nutritionist that I worked late and liked to cook my own meals, but her only word of advice was to try harder to eat earlier. With that, we wrote up three goals that I would work on in the weeks prior to receiving the device -- to eat breakfast, to eat dinner earlier, and to make more time to exercise during the work day.

We discussed how to eat in the days following balloon insertion: a day of clear liquids, a day of soft foods, and then back to normal. During the study period it was suggested that I try to eat 1300 to 1500 calories a day and try to exercise 2.5 hours a week. Oddly enough, we didn’t discuss what to eat, just a caloric number to hit.

Looking back, I wanted the weight loss study to point out unhealthy habits that were preventing me from weight loss, but I learned that the study was merely about weight loss and not correcting or uncovering habits.

My first clue was the dietician recommending soda and milkshakes if I felt too full during the study period to meet my caloric goal. Already exercising greater than 2.5 hours a week, I made sure to let the nutritionist know that I would not be decreasing it for the sake of the study.

Two weeks later, I was ready for balloon swallowing. To prep, I was to take an anti-spasmodic, anti-nausea and antacid. The first two are to be taken the day prior and for five days after insertion and as needed thereafter. The antacid is to be taken for the entirety of the course of the study. It felt like and still does feel like a lot of medication, for me at least.

The study is a blind study meaning the research knows but you, the patient do not. You may get the balloon or you get nothing. Yes, all of that testing and hope and I got a 50/50 shot of swallowing the actual balloon or swallowing a placebo.

The placebo is the same size and approximate weight of the balloon and filled with sugar. Even if you get the placebo, it is still attached to a catheter and they just pretend to fill it.

Study participants in prior medical studies for this device lost about half of their excess weight. From message boards that I’ve looked at outside of the tightly controlled test environment, people seem to have lost anywhere between zero and 30 pounds. There is no long term data for this device and study participants are not followed past a year.

I find out soon whether or not I have the placebo. But I will tell you: I’m not hopeful that I have the balloon because in the weeks since I swallowed the device, I have yet to lose any weight. After the big reveal, if I’m still considered obese, I have the option to have the balloon.

Thinking of the extreme measures I’ve taken to lose weight without success, I wonder why I’d put myself through something else. I do know that I want to love myself at any size, but I’m just not sure how to.