Ethical Concerns about the DiRECT approach to diabetes

By Megrette Fletcher, M.Ed., RD, CDE

Everyday, assertions of the ‘latest approach’ to prevent type 2 diabetes continue to emerge.

However, when these claims are examined, ethical concerns arise. Specifically, one such claim from the article published in Clinical Endocrinology News on June 9, 2019 How to reverse type 2 diabetes with a crash diet: the DiRECT approach”.  This article reported on the research by Dr. Roy Taylor and the DiRECT trial, where the headline claims, “Seventy-percent of type 2 diabetes patients who lost more than 33 pounds on a liquid diet over a few months and kept it off, were free of the disease at 2 years”[1].

Thinking about the use of this as a ‘first line treatment’ is really problematic because the study started with 1510 potential people to enroll, but only 298 sign up. This is less than 1 in 5 people. In the intervention group, only 14 participants met the goal of  >=15 kg loss AND achieving remission (11%), which is less than 1% of the original potential enrollees. So not a roaring endorsement for acceptability or achievability. – Deb Burgard, PhD

The 70% number, in actual people, and not an eye-grabbing percent, was 17 people.  Deb Burgard, Ph.D., explains why lifestyle studies like this are concerning, “Thinking about the use of this as a ‘first line treatment’ is really problematic because the study started with 1510 potential people to enroll, but only 298 sign up. This is less than 1 in 5 people. In the intervention group, only 14 participants met the goal of  >=15 kg loss AND achieving remission (11%), which is less than 1% of the original potential enrollees. So not a roaring endorsement for acceptability or achievability.”  There were three control group participants who were able to meet the weight loss goals which is how the study was able to report 17 people achieved 15 kg weight loss and kept it off for 2 years.

Professionals should be hopeful about the idea of lifestyle change as part of diabetes management but not to focus on weight. In the DiRECT trial, there are 44 more people who achieve remission at 2 years even without 15kg weight loss.  This is important because it begins to shine a light on the flawed science, which assumes that it is weight loss that is creating the health change, when it is likely the behaviors themselves, regardless of weight change that is producing health improvements.

The result from DiRECT trial illustrates the need for research which focuses on behaviors, support and non-stigmatizing health care for people with diabetes. It is also why more and more professionals are shifting to a weight-neutral approach to help clients manage diabetes.

A weight-neutral approach states that it isn’t weight loss that is produces the beneficial outcomes but rather it is the actual behaviors associated with diabetes management, such as accessibility to regular meals, eating a balanced diet, activity, medication, stress management, monitoring and access to regular care that can produce beneficial outcomes. This change from a weight-focused approach to a behavioral approach shifts the effort from weight loss to education and support. Burgard explains why it is important to remember that “The vast majority of people in the intervention arm are not achieving the extreme weight loss (149-14=135, 91%)”.

When asked about the study, the professionals at Weight-Neutral for Diabetes Care, WN4DC.com explained their concerns.  “This study is an iatrogenic induced eating disorder. That means it is inducing an eating disorder as a type of treatment” explains Vicki Rhoades a Naturopathic Doctor.  This is a real concern and The National Eating Disorder Association (NEDA) reports that in the USA, up to 30 million people suffer from an eating disorder such as anorexia nervosa, bulimia nervosa, or binge eating disorder. This number is similar to the 2015 Centers for Disease Control and Prevention (CDC) findings that 30.3 million Americans have diabetes.[2]  Like diabetes, much of disordered eating goes unrecognized and untreated, and only one out of ten people with disordered eating will receive treatment.[3]  Yet the overlap of these two conditions is shockingly high. Disordered eating behaviors may affect up to 40% of patients with type 2 diabetes mellitus.[4]

What is missing from these types of headlines and news reports is the harm that they inflict, explains Kelly Demers RD. “Headlines claiming diabetes is ‘reversible’ are very dangerous!”  Many of these weight loss protocols cut calories to as low as 415 calories/day which isn’t an adequate number of calories to meet essential nutritional or energy needs.”  Louise Adams, a clinical psychologist in Australia explains, “…starving people might mean they’re too depleted to have diabetes symptoms, but this doesn’t mean a “cure”, it means they’re too sick to be sick!”

The typical messaging surrounding diabetes is overly simplistic encouraging an individual to focus on losing weight or lose 10% of their current body weight. Unfortunately, this messaging erroneously associates weight change with curing or treating diabetes. This unintentional association continues to be popularized in the media and press instead of focusing on the day-to-day support needed to manage diabetes. It is easy to concentrate or emphasize weight-based outcomes, which only reinforces the fallacious notion that weight loss is a behavior. The level of harm that is associated with promoting weight loss is far more complex than avoiding treatment, and it is woven into the research of weight stigma, weight bias and the impact of disordered eating.

This is an image from the WN4DC professionals Facebook group, that was taken on May 28th, 2019 where a member posted about a client delaying care because he thought eating ‘better’ would cure his diabetes.

Why A Weight-Neutral Approach to Diabetes Care is Essential

Shifting the focus from weight-centered to a weight-neutral approach can avoid harmful outcomes. Healthcare providers should think of weight-neutral care as a type of universal precaution to stop perpetuating disordered eating, weight cycling, weight stigma while improving overall wellbeing. Weight-neutral care takes the emphasis off of weight loss, which is scientifically unproven in both the DDP Outcome Study and the Look AHEAD trial and instead prescribes evidence-based interventions which promote health and wellbeing regardless of weight change.

A weight-neutral provider avoids triggering language and works to become aware of weight bias and weight stigma. Weight-neutral science separates health behaviors from outcomes and is designed to identify confounding variables including weight stigma, weight bias, social determinants of health, and social isolation and how these are impacting overall health.

About: Megrette Fletcher M.Ed., RD, CDE is a diabetes educator, dietitian, author, and owner of WN4DC.com. She is a co-host of the WN4DC Symposium, a 30-day, self-paced, online professional training that looks at the intersection of diabetes care, counseling, and disordered eating. To learn more about her visit www.megrette.com.

1] Otto, M. Alexander. “How to Reverse Type 2 Diabetes with a Crash Diet: the DiRECT Approach.” MD Edge, Endocrinology, 9 June 2019, www.mdedge.com/endocrinology/article/

[2]  CDC, July 2017 National Diabetes Statistics Report, 2017 Estimates of Diabetes and Its Burden in the United States. https://www.cdc.gov/media/releases/2017/p0718-diabetes-report.html

[3] South Carolina Department of Mental Health. “South Carolina Department of Mental Health.” Eating Disorder Statistics, 1 June 2019, http://www.state.sc.us/dmh/anorexia/statistics.htm.

[4] García-Mayor, Ricardo V., and Francisco J. García-Soidán. “Eating Disorders in Type 2 Diabetic People: Brief Review.” Diabetes & Metabolic Syndrome: Clinical Research & Reviews, vol. 11, no. 3, 2017, pp. 221–224., doi:10.1016/j.dsx.2016.08.004.


Learn more about weight-neutral diabetes care by attending the WN4DC Symposium, which starts July 8th.  Attend this 30-day self-paced guided training and learn from 18 of the world’s leading experts in the comfort of your home.