A review and critique of published real-world weight management program studies

ABSTRACT

Background: Beyond the essential but somewhat artificial conditions that typify formal clinical studies, real-world evidence (RWE) of weight loss program effectiveness is paramount for an accurate assessment of such programs and refinement of best practices.

Objectives: To evaluate the current state of RWE studies and publications on weight loss, identify the range of weight loss components being used in RWE programs, and to provide a general overview of the consistency or lack of consistency with regard to measuring and reporting outcomes.

Methods: A structured search of PubMed was performed to identify relevant English-language publications from 2006 to December 2017 that reported real-world studies of weight loss among adults. Duplicates, non-relevant publications, articles on weight loss surgery, pediatric studies, randomized controlled trials, studies with self-reported weight loss, no objective weight measures, or that failed to include weight loss results were excluded.

Results: This review included 62 RWE publications. Forty-nine studies included dietary intervention, 37 included exercise, 29 included motivational counseling, and 5 contained some patients who had pharmacologic treatment as part of their weight loss regimen. The numbers of participants per study ranged from 10 to more than 3 million. The interventions reported in the publications included diet, exercise, counseling to promote diet and/or exercise, motivational counseling, and pharmacotherapy, and various combinations of these.

Conclusions: Despite general acceptance that weight loss programs are capable of facilitating successful outcomes, this review revealed substantial inconsistency in the design and reporting of such programs, making it very difficult to draw conclusions about the comparative merits of different real-world weight loss strategies/components. In addition, there was a marked lack of congruence with current weight loss management guidelines, and notably few studies incorporating anti-obesity medications. There clearly is a need for greater rigor and standardization among designing and reporting RWE weight-loss studies.

KEYWORDS:

• Real-world evidence
• weight management
• effectiveness
• outcomes
• anti-obesity medications
• dietary intervention

Acknowledgments

Writing assistance was provided by Ed Kimball, PhD through Churchill Communications (Maplewood, NJ), and funded by Novo Nordisk, Inc.

Declaration of interest

C Primack served on an advisory board and speakers bureau for Novo Nordisk, Inc. and Orexigen Pharmaceuticals, Inc. Postgraduate Medicine peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This study was funded by Novo Nordisk, Inc.