Weight and Healthcare

with Ragen Chastain

Examining the intersections of weight science, weight stigma, and healthcare and what evidence, ethics, and lived experience teach us about healthcare and public health best practices for higher-weight people. weightandhealthcare.substack.com

  1. Aug 15

    Looking Back at Look AHEAD Part 2 - The 10% Group

    This is the Weight and Healthcare newsletter! If you like what you are reading, please consider subscribing and/or sharing! In part 1 we looked at the basics of the Look AHEAD Trial of weight loss to improve cardiovascular outcomes. The trial was cancelled 9.6 years into its intended 13.5 year follow up for “futility” when analysis found no statistically significant difference in cardiovascular outcomes between a group that engaged in “intensive” caloric restriction, exercise, and, in some cases, diet drugs, and a group that got three counseling sessions a year about diabetes management. One of the claims that I often see people make is that the group that maintained at least a 10% loss had better outcomes. We saw this recently in the write-up of the Foundayo trial, in which they claimed, without context that “patients who had a weight loss of 10% or more through a lifestyle intervention had a 21% reduction in cardiovascular events.” I mentioned in that piece that this was an analysis of a small subgroup. There are some real caveats around this and other claims about the 10% weight loss group so let’s dig into it. For this we’ll look at “Four-year weight losses in the Look AHEAD study: factors associated with long-term success” by Wadden et al. As always I’ll indent the quotes so you can skip the weight stigma. In their writing ILI is the abbreviation for the weight loss group and DSE is the abbreviation for the control group. In general they discuss the weight loss: “At year 4, 35% of ILI and 18% of DSE participants achieved the study-wide goal of losing ≥7% of initial weight (P Said another way, the study goal was to produce weight loss of just 7% or more of body weight and 65% of the people who were subjected to these “intensive” interventions including diet drugs didn’t hit even that modest goal. Also, 23% of the ILI group lost 10% or more of body weight, but 10% of people in the control group that didn’t do any of these interventions did so as well. This again raises questions about the necessity of such extreme restriction even for people who believe that weight loss creates health benefits (which, again, this study does not show, since there is no way to determine if any health differences are from weight loss or behaviors, and research that actually sought to answer that question found no relationship between small amounts of weight loss and health changes in correlational analysis, and posited that it was more likely that behaviors, social support, and engagement in the healthcare system were likely to be driving the health outcomes.) The authors of the Look AHEAD paper also point out that: “significantly more DSE than ILI participants (45% vs. 26%) had gained above their baseline weight at year 4 (all P values What they aren’t being clear about is that the DSE (control) group had modest weight gain from baseline while not participating in a weight loss intervention. Meanwhile, just four years in, more than a quarter the ILI (intervention) group weighed more than when they started. Now, there is nothing wrong with being higher-weight or gaining weight, but I would say that there is something seriously wrong with a so-called healthcare intervention that subjects people to “intensive” food restriction, physical activity, and diet drugs and then has the opposite of the intended effect for at least 26% of the participants. This particularly does not age well given that we now know that the intervention would be cancelled for futility for failing to impact the intended health outcomes. When it comes to the group who lost 10% the Look AHEAD authors write that: “[Figure] 3 shows 887 ILI participants who lost ≥10% of initial weight in the first year and shows the number of these participants who achieved a loss of this size at year 4 (N = 374) or, alternatively, maintained losses of 5.0–9.9% (N = 251), 0–4.9% (N = 174), or gained above their baseline weight (N = 88). As shown, fully 42% of this subsample achieved a loss ≥10% at year 4, and a total of 70.5% maintained a loss ≥5%. It should be made clear that “fully 42% of this subsample” refers to 42% of 35% of the original sample. So out of the 2570 original people in the intervention arm, 887 participants (about 35%) lost ≥ 10% at year 1. But at year four, only 374 (about 14.5% of the original group) were still at 10%. Percentage wise, that means fewer than half of the people who had lost 10% or more of their body weight in the first year were still at or over 10% by year four and that, overall, only about 15% of the total group managed 10% weight loss for even 4 years. But there is more to this story, let’s look at their Figure 3A that shows the weight trajectory of this group: Image text: Figure 3 A. Weight loss trajectories over 4 years in the 887 participants in the Intensive Lifestyle Intervention (ILI) who, at year 1, lost ≥ 10% of initial weight. The figure shows the number of participants who, at year 4, maintained a loss of 10% or more of initial weight (N = 374), of 5.0–9.9% (N = 251), or of 0–4.9% (N = 174) or who gained above their baseline weight (N = 88). You’ll note that everyone has regained from their low point, 9.9% (88 people) had already regained more weight than they lost and the majority are still on a trajectory to continue to gain weight after this follow up. If we go back to their quote, they claim that this figure shows percentages of people who “maintained losses of 5.0–9.9% (N = 251), 0–4.9% (N = 174).” I do not think that the word “maintained” reflects the reality that these people’s weight trajectory is going straight up. Catching a group of people at 5% weight loss on their way up is not the same thing as “maintaining” a 5% weight loss. Content note: This next section talks about calories, exercise, disordered eating/eating disorders, if that may be harmful to you you can scroll down to “Discussion.” The researchers note that “Participants who maintained the [10%] loss, compared with those who did not, attended more treatment sessions and reported more favorable physical activity and food intake at year 4.” Again, this begs the question as to whether behavior or weight loss actually created any health difference. It also begs another, much more troubling question. Below is their Figure 4 which shows the characteristics of the subset of subjects who took self-reported surveys about their food and exercise behaviors. Note that those who maintained a 10% loss in general were consuming about 1565.5 calories a day (fewer than the 1,570 calories subjects in the Minnesota STARVATION study were given during the starvation stage) and burning about 2,000 calories weekly through exercise. Applying the Paffenburger Activity Questionnaire that these authors are using to the Minnesota STARVATION study participants, those participants were expending about 2200 calories per week. One thing the authors don’t mention in this sub analysis, or the original analysis, is the possibility that they created disordered eating/eating disorders in part of their population and then celebrated it as “long-term success.” Discussion The first sentence of their discussion section states: “Participants in the Intensive Lifestyle Intervention achieved a 4.7% reduction in initial weight at year 4. This loss is among the largest reported at this length of follow-up for individuals in a randomized controlled trial who were treated by a lifestyle intervention” I do not think that this is the flex they think it is. Giving people less food and similar activity to a study on starvation over four years produces 4.7% weight loss - an amount of weight that some people fluctuate monthly through their menstrual cycle? The phrase “who cares?” comes to mind. To further demonstrate the issues with this study, in the discussion section these authors compare their “maintainers” to the National Weight Control Registry which I have discussed before as perhaps the worst example of the truly ridiculous methodology that passes for “science” when it comes to weight loss and health. In general, when people cite the Look AHEAD study as proof of efficacy of weight loss interventions, you can suggest that they look back at the actual findings of the study. Even these authors are honest that “Look AHEAD’s study design prevents us from definitively determining the contribution to long-term weight loss of the lifestyle intervention’s different treatment components.” What they aren’t so clear about is that Look AHEAD’s study design prevents them from knowing if weight loss had anything to do with any of the health benefits. Especially since, as we talked about in part 1, research finds that weight-neutral interventions can produce similar or greater benefits with less risk. In general, whenever someone claims that a study shows that weight loss creates health benefits, the first question you can ask is “what mechanism was used to determine whether weight loss or behavior change created the differences in outcomes?” If there isn’t one, then they can’t conclude that weight loss did anything at all. If you want to learn how to read between the lines of weight and health research, this month’s online workshop is about exactly that. I’ll teach you the basics of breaking down research and analyzing media article and social media to break through the BS and get to the truth of what the research finds (and what it doesn’t). There is a pay-what-you-can option so money isn’t a barrier and all registrants get a video. Details and Registration here! If you appreciate the work I do here, you can support my ability to do it by becoming a free or paid subscriber! Liked the piece? Share the piece! More researchThe Research Post More resourcesThe Resource Post *Note on language: I use “fat” as a neutral descriptor as used by the fat activist community,

  2. Jul 18

    GLP-1 Study is an EPIC Fail Part 2 - Analysis

    In Part 1 we started discussing the study Two Years After Stopping GLP-1s, Most Patients Sustain at Least Some Weight Loss by Bartelt et al. which I identified as possibly the worst, and definitely among the top 3 worst, studies I’ve ever analyzed. In part 1 we talked about the platform (Epic Research), the researchers, and the basic methodology for reporting. Today we’re going to get into the analysis. Remember that there are two sources, the first is the actual article, the second is what I am calling the supplementary materials that is a pdf that is linked (though not at all clearly) in the article. We’ll compare the claims made in the article to the data shown in the supplementary materials. I think as we get into this it may be helpful (and maybe just a bit comforting) to remember that this was not published in a peer reviewed journal - it’s Epic publishing Epic’s research on Epic’s website. We’ll begin with the most basic claim: “we studied 188,722 patients who stopped using a GLP-1 medication after being on it for at least 90 days and who lost at least 5 pounds while on it.” You might be thinking “wait - in Part 1 you said the study population was 323,782, what happened to the other 135,060 people? Let’s go on this journey together. We’ll start by looking at their data. In the supplementary materials, Table 1: Characteristics of the Study Population looks like this: So they say in the article that they studied 188,722 patients but the very first line of the supplementary materials chart about the study population says that the total number of patients was 323,782. But it gets a bit weirder, if you add up all the participants in the different age categories you get 323,750, 32 short. If you add up the totals across the drug groups you do get 188,722, if you add up the participants in the weight loss category you get 323,782. If you add up the diabetic status you get 323,782. What is going on here? Maybe they originally looked at 323,782 records of which only 188,722 were not excluded for some reason, and maybe 32 of the participants did not have an age on their electronic health record? At least the number of people across the drug groups in the supplementary materials chart matches the number of people they claim to have studied but this is, in the absolute more charitable description, an extremely confusing way to present this data. In part 1 we discussed the fact that the inclusion criteria were not particularly stringent but the biggest issue, to me, is that the researchers appear to have just done calculations with whatever data they happened to have, but reported it and drew conclusions as if they had consistent data on all participants. For each of the three drug groups (semaglutide, liraglutide, tirzepatide), they present an interactive graph that shows “the proportion of patients by amount of weight regained or lost after stopping [liraglutide/semaglutide/tirzepatide].” Let’s dig in. In the article we find Figure 1 - Proportion of Patients by Weight Change After Stopping Semaglutide we can see in the lower left “n=139,972 patients.” But if you look at the supplementary materials you find Table 2 Proportion of Patients by Weight Change After Stopping Semaglutide. This is the table from which they are drawing the data for Figure 1. The final column of the supplemental table is “patients” and the number in that column represents the number of the original 139,972 patients who had taken (and subsequently stopped taking) semaglutide for which the researchers had a weight at each month of their calculation. At month 1, the researchers had a weight for 68,754 of the patients and this number trends steadily downward until month 24 when they only had weights for 2,650 of the original 139,972 patients. At literally no point does Figure 1 in the original article give data for the n=139,972 patients the label claims. In the liraglutide group the graph in the article says n = 23,377. The supplementary tables show that in month 1 they had weights for 11,580. That steadily declined until month 24 they had weights for 1,268 of the population. In the tirzepatide group, the article says n= 25,373 patients. At month 1 they had weights for 12,909 patients which steadily declined until at at month 24 they only had a weight for 145 people (that is not a typo, they were doing the two year calculation upon which they drew their bold conclusions with only one hundred and forty five of the original 25k+ people represented!) This is such a bonkers way to do this that I actually emailed them, using the semaglutide table as an example, to make sure I was understanding this correctly. They assured me that I was: “Yes – there were 139,972 total patients on semaglutide who met the conditions in the study cohort. The patient count in Table 2 represents the number of patients that had a weight reading in a given month, so patients can be represented in multiple months.” So let’s discuss the “key findings” At 24 months post-cessation, 56% of semaglutide, 52% of liraglutide, and 55% of tirzepatide patients kept the weight off or lost additional weight. Complete weight regain occurred in 23% of semaglutide, 21% of tirzepatide, and 27% of liraglutide users at 24 months. Weight trajectories stabilized after 12 months, with only small variations in the distribution of weight outcomes through year two. Remember that when they state these 24 month findings (or when in the title they say “Most Patients Sustain at Least Some Weight Loss,”) these statistics are drawn from information for only 1.9% of the semaglutide group, 5.4% of the liraglutide group, and 0.57% of the tirzepatide group. When they say kept the weight off or lost additional weight, subjects would qualify if they maintained 1% of the weight they lost. EDIT - I’m adding this paragraph for additional clarification based on a great comment below. If you look at their percentages, it can seem like a lot of people didn’t regain weight. For example in the Semaglutide group, for example, at 1 month the “doubled their weight loss group” was 5.01% of 68,754 participants. That’s that’s about 892 people which is 0.64% of the original 139,972 people. At 24 months it was 25.89% of 2,650 people. That’s about 686 people which is about 0.49% of the original 139,972 people. As I mentioned in part 1, we also don’t know if this miniscule percentage of the total group even actually stopped taking the drugs, or if they started getting them from a different source that did not add them to their medical chart. What happened to the 98.1% of the semaglutide group, 94.6% of the liraglutide group, and the staggering 99.43% of the tirzepatide group for whom the researchers did NOT have a weight at 24 months? Is it more likely that people who were regaining weight did not come back to get weighed in? These researchers have absolutely no idea and they don’t seem to care. (They said that weight trajectories stabilized at 12 months so even if we look at the data at 12 months they only had weights for 12.7% of the semaglutide group, 18.5% of the liraglutide group, and 8.1% of the tirzepatide group.) Under limitations they state “We allow a patient to be included in each month, using their highest weight in that month. Patients who have repeated weight measurements might be the extremes of weight change.” Gentle readers, I would say that this is the least of their limitations. The fact that they are stating these incredibly broad conclusions about weight regain (including in the title!) based on a tiny fraction of the data they’ve led us to believe is included, and that they AT NO POINT disclose any of that in the main paper is, to me, unforgivable. Horrifyingly, in researching this piece I found other studies that actually cited this one so I’ll end this by saying that this study completely lacks the academic rigor or appropriate methodology necessary to be used to counter research showing high rates of weight regain after GLP-1 cessation. GLP-1s are being taken by a huge percentage of people and being prescribed (and in some cases pushed) by many prescribers, research like this has the potential to do incredible harm by generating blatant misinformation. We have to do a whole lot better than this. This month’s online workshop is How to Be Your Own Medical Advocate. You’ll learn strategies to advocate for yourself to help you get the evidence-based, compassionate, healthcare you deserve, and what your options are if you don’t. There’s a pay-what-you-can option to make sure money isn’t a barrier and all registrants get a video in case you can’t make it live. Details and registration are here! If you appreciate the work I do here, you can support my ability to do more becoming a free or paid subscriber! Liked the piece? Share the piece! More researchThe Research Post More resourcesThe Resource Post *Note on language: I use “fat” as a neutral descriptor as used by the fat activist community, I use “ob*se” and “overw*ight” to acknowledge that these are terms that were created to medicalize and pathologize fat bodies, with roots in racism and specifically anti-Blackness. Please read Sabrina Strings’ Fearing the Black Body – the Racial Origins of Fat Phobia and Da’Shaun Harrison’s Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this. Get full access to Weight and Healthcare at weightandhealthcare.substack.com/subscribe

4.2
out of 5
26 Ratings

About

Examining the intersections of weight science, weight stigma, and healthcare and what evidence, ethics, and lived experience teach us about healthcare and public health best practices for higher-weight people. weightandhealthcare.substack.com