American College of Lifestyle Medicine Partners with True Health Initiative to Develop New Method for Evaluating Strength of Evidence of Lifestyle Interventions

The American College of Lifestyle Medicine, in collaboration with True Health Initiative, has announced the development of Hierarchies of Evidence Applied to Lifestyle Medicine (HEALM), a new method for evaluating strength of evidence (SOE) appropriate for assessing Lifestyle Medicine interventions. Prior to HEALM, current methods for assessing strength of scientific evidence relied on the contributions of randomized controlled trials (RCTs) to assign a “Grade A” level of evidence. The objective of this newly published study was to conduct a systematic review to characterize strength of evidence (SOE) tools in recent use, identify their application to lifestyle interventions for improved longevity, vitality, or successful aging, and to assess implications of the findings. The results of the systematic review informed the development of HEALM.

The American College of Lifestyle Medicine (ACLM), in collaboration with the True Health Initiative (THI), today announced the development of Hierarchies of Evidence Applied to Lifestyle Medicine (HEALM), a new method for evaluating strength of evidence (SOE) appropriate for assessing Lifestyle Medicine interventions. This systematic review was completed by investigators David Katz, Micaela Karlsen, Marissa Shams-White and Ayumi Saito. They were guided by an expert panel that included Mei Chung, Lawrence Green, Jonathan Fielding and Walter Willett. The work was published in BMC Medical Research Methodology volume 19, Article number: 178 (2019).

Unhealthy lifestyle behaviors are a leading cause of chronic illness, with more than 80 percent of deaths resulting from noncommunicable diseases. Lifestyle Medicine, using a whole food, plant-predominant dietary lifestyle, regular physical activity, restorative sleep, stress management, avoidance of risky substances and positive social connection, is emerging as a uniquely effective and beneficial medical specialty for the prevention, treatment and reversal of chronic disease. Until now, however, current methods for evaluating SOE have relied on the contributions of randomized controlled trials (RCTs) to assign a “Grade A” level of evidence. This dependence on randomized controlled trials has hindered the ability to issue strong recommendations and prohibitions around specific lifestyle behaviors. HEALM provides an answer for this problem by allowing the strongest rating of evidence to be achieved in several different combinations of different types of research studies, not solely with RCTs.

“Evaluating strength of evidence is a crucial step in issuing health guidelines and recommendations,” said panel member David Katz, MD, MPH, FACLM. “Currently, SOE is based on a hierarchy that places randomized control studies (RCTs) as the gold standard in scientific research. While HEALM acknowledges the value of RCTs, we also recognize that the current system for evaluating the strength of evidence is best suited to examine conventional medicine such as pharmacotherapy and discrete procedures.”

When applied to lifestyle interventions, RCTs have certain limitations: 

  • It is difficult or impossible to assign study participants to a specific behavior and expect adherence over decades or the lifespan
  • Cost would make such decades-long RCTs prohibitively expensive
  • The results may only be relevant to the study population, and may be less generalizable to the larger population
  • Ethical considerations prevent assigning specific behaviors in a long-term research setting (such as smoking more or eating more unhealthy foods)

The authors also suggest a formalized process by which an investigator can choose which SOE tool is the appropriate one to use for a given research question. Titled Evidence Threshold Pathway Mapping (ETPM), this process will identify when HEALM is the right SOE tool to use, or another existing tool, such as Grading of Recommendations, Assessment, Development and Evaluation (GRADE) is the right tool.

With HEALM, there is more than one path by which research can arrive at a “Grade A” level of evidence, and it does not necessarily require RCTs.

“Evidence is strongest when research results from different types of studies are consistent, and conclusions are strongest when the specific contributions of different methods are acknowledged,” said co-investigator Micaela Karlsen, PhD, director of the Lifestyle Medicine Economic Research Consortium, a special project of ACLM’s. “Using HEALM, scientists can draw conclusions about the effects of lifestyle behaviors and assign the strongest rating of evidence without waiting for studies (RCTs) that will never be feasible to conduct.”

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“The establishment of a tool for qualifying prescriptive practices in lifestyle intervention is a monumental step in the application of lifestyle as medicine,” said George Guthrie, MD, MPH, FACLM and past-president of ACLM who initiated the project. “We trust that HEALM will be validated by others and find widespread use as tool to evaluate the science as it relates to Lifestyle Medicine. This should help us to issue clear recommendations for health behaviors to prevent disease and restore health to those suffering from many of our chronic Western diseases.”

ABOUT ACLM: ACLM is the medical professional society providing quality education and certification to those dedicated to clinical and worksite practice of Lifestyle Medicine as the foundation of a transformed and sustainable health care system. Lifestyle Medicine treats, often reverses and prevents chronic disease through the combined use of evidence-based lifestyle therapeutic approaches, such as a predominantly whole food, plant-based diet, regular physical activity, adequate sleep, stress management, avoiding use of risky substances and positive social connection. ACLM members are united in their desire to identify and eradicate the root cause of disease, and create a new systems approach to health. Learn more at http://www.LifestyleMedicine.org. To register for the Lifestyle Medicine 2019 conference, visit http://www.LMConference.org.

ABOUT THE TRUE HEALTH INITIATIVE: As an organization spun out of ACLM in 2016, THI is a global coalition of world-renowned specialists, fighting fake facts and combating false doubts to create a culture free of preventable disease, while conjointly safeguarding planetary health using the time-honored and evidence-based practices of lifestyle as medicine. As the authoritative voice on lifestyle as medicine, we are working to change policy, by enlisting leading experts and commissioning a collection of research to fight fake facts and fix a broken system; change minds, by demonstrating and disseminating the global consensus on the fundamental, evidence-based truths of lifestyle as medicine; and improve lives, by working with communities to create a healthier culture that adds life to years and years to life. Learn more at http://truehealthinitiative.org

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“This should help us to issue clear recommendations for health behaviors to prevent disease and restore health.”